AIGISRx Envelope for Prevention of Infection Following Replacement With an Implantable Cardioverter-Defibrillator (ICD) (CITADEL)
This study is currently recruiting participants.
Verified July 2011 by TYRX, Inc.
Sponsor:
TYRX, Inc.
Information provided by:
TYRX, Inc.
ClinicalTrials.gov Identifier:
NCT01043861
First received: January 5, 2010
Last updated: July 19, 2011
Last verified: July 2011
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Purpose
The purpose of this study is to compare the incidence of cardiac rhythm management device (CRMD) infection and CRMD mechanical complication after CRMD replacement with an Implantable Cardioverter-Defibrillator (ICD) and AIGISRx Anti-Bacterial Envelope, to the incidence after replacement with an ICD and no AIGISRx.
| Condition |
|---|
|
Implantable Cardioverter-Defibrillator Infection |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | AIGISRx Anti-Bacterial Envelope and Custom Mesh for Prevention of Infection Following Cardiac Rhythm Management Device Replacement With an Implantable Cardioverter-Defibrillator (ICD) |
Resource links provided by NLM:
Further study details as provided by TYRX, Inc.:
Primary Outcome Measures:
- Major CRMD Infection [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- CRMD Mechanical Complication [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2300 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
CRMD replacement with ICD and AIGISRx
Patients who have undergone CRMD replacement with an ICD and the AIGISRx Anti-bacterial envelope, with or without lead revision (Prospective Arm)
|
Detailed Description:
Cardiac rhythm management device (CRMD) infection is associated with significant morbidity and expense. The frequency of CRMD infection is increasing faster than the frequency of CRMD implants, suggesting more effective prophylactic strategies are needed.
The AIGISRx Anti-Bacterial Envelope is an FDA-cleared polypropylene mesh that is intended to securely hold a pacemaker pulse generator or defibrillator (ICD) in order to create a stable environment when implanted in the body. It contains the antimicrobial agents, rifampin and minocycline, which have been shown to reduce infection in an in vivo model of bacterial contamination following surgical implant of the generator or defibrillator.
This is a prospective, observational, multicenter registry of subjects undergoing CRMD replacement with an ICD and AIGISRx, with or without lead revision/addition. The registry subjects will be compared to a published historical control group undergoing CRMD replacement with an ICD and no AIGISRx, with or without lead revision/addition. The primary study endpoints are major CRMD infection and CRMD mechanical complication during the 12 months following CRMD replacement with a ICD.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients who have undergone CRMD replacement with an ICD, with or without an AIGISRx Anti-bacterial Envelope, at US medical centers.
Criteria
Inclusion Criteria:
- Qualifying CRMD Implant procedure was replacement with a ICD and AIGISRx, with or without lead revision/addition
- Received a complete AIGISRx Anti-Bacterial Envelope Model# 3122 or #3133 according to the Instructions for Use (IFU)
- Clinically stable to tolerate procedure
- 18 years or older
- Able to return for follow-up care through the 12-month visit, or able to have referring physician provide follow-up data to study site by telephone
Exclusion Criteria:
- Unable/unwilling to provide informed consent
- Contraindication to receiving the AIGISRx device, in accordance with the package labeling
- Pregnant or was at risk for becoming pregnant in the 30 day period following the Qualifying CRMD Implant
- Current CRMD infection, or the indication for Qualifying CRMD Implant was replacement of CRMD that was explanted for infection
- Clinical diagnosis of an active infection at the time of CRMD implant, including pneumonia, urinary tract infection, endovascular, cellulitis, bacteremia, or other major systemic infection. (Note: asymptomatic bacteriuria without UTI is not an exclusion criterion)
- Generator replacement required planned lead extraction
- Participating in another clinical study evaluating a drug or device designed to reduce cardiovascular rhythm management device infections
- Life expectancy of less than 6 months
- Expected to receive a heart transplant within 6 months
- With the exception of the elderly in good mental health, all vulnerable subjects as defined by the FDA Office of Human Research Protection or local IRB will be excluded
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01043861
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Contacts
| Contact: Steve A. Sisk, MsSc. Pharm | 609-894-2289 | ssisk@tyrx.com |
| Contact: Robert J Hamlin, BSc | 732-964-1123 | rhamlin@tyrx.com |
Hide Study LocationsLocations
| United States, Alabama | |
| Stringfellow Memorial Hospital and Regional Medical | Recruiting |
| Anniston, Alabama, United States, 36207 | |
| Contact: Mohammad Kamran, M.D. 256-240-8079 mkamran@1962@yahoo.com | |
| Principal Investigator: Mohammad Kamran, MD | |
| Princeton Medical Center | Recruiting |
| Birmingham, Alabama, United States, 35211 | |
| Contact: Ibrahim R Hanna, MD 205-780-4330 cwatson@cardiologypc.com | |
| Contact: Carrie Watson 205-780-4330 cwatson@cardiologypc.com | |
| Principal Investigator: Ibrahim R Hanna, MD | |
| Decatur General Hospital | Recruiting |
| Decatur, Alabama, United States, 35601 | |
| Contact: Tracy Neal, MD 256-341-2890 | |
| Contact: Julie Smith 256-341-2890 | |
| Principal Investigator: Tracy Neal, MD | |
| Eliza Coffee Memorial Hospital | Recruiting |
| Florence, Alabama, United States, 35630 | |
| Contact: Sabrina Whitten 256-766-8570 sdswhitten@gmail.com | |
| Principal Investigator: Hisham Baalbaki, MD | |
| Riverview Regional Hospital | Recruiting |
| Gadsden, Alabama, United States, 35901 | |
| Contact: Mary Sharpe, RN 256-546-6200 ext 104 mwsharpe@bellsouth.net | |
| Principal Investigator: B.J. Patel, MD | |
| United States, Arizona | |
| Arizona Heart Hospital | Recruiting |
| Scottsdale, Arizona, United States, 85251 | |
| Contact: Amanda Fuller 480-246-3085 Afuller@aacheart.com | |
| Principal Investigator: David Riggio, MD | |
| United States, California | |
| Cardiac Rehabilitation Sansum Clinic | Withdrawn |
| Santa Barbara, California, United States, 93105 | |
| Community Memorial Hospital | Recruiting |
| Ventura, California, United States, 93003 | |
| Contact: Ishu V Rao, MD 805-653-0101 deanna.romero@hotmail.com | |
| Contact: Deanna Romero 805-653-0101 deanna.romero@hotmail.com | |
| Principal Investigator: Ishu V Rao, MD | |
| Watsonville Community Hospital | Recruiting |
| Watsonville, California, United States, 95076 | |
| Contact: Benjamin N Potkin, MD 831-332-3617 robodon3@hotmail.com | |
| Contact: Robby O'Donovan 831-332-3617 robodon3@hotmail.com | |
| Principal Investigator: Benjamin N Potkin, MD | |
| United States, Florida | |
| Citrus Memorial Hospital | Recruiting |
| Inverness, Florida, United States, 34452 | |
| Contact: Sherry Strickland, RN 352-751-3356 sstrickland@citruscardiology.com | |
| Principal Investigator: Stephen Stark, MD | |
| Osceola Regional Medical Center | Recruiting |
| Kissimmee, Florida, United States, 34741 | |
| Contact: Sheila Villaver 407-846-0626 | |
| Principal Investigator: Nashaud Shaik, MD | |
| University of Miami | Not yet recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Wedad Kassira, MD 305-243-5852 wkassira2@med.miami.edu | |
| Principal Investigator: Roger Carillo, MD | |
| Orlando Regional Hospital | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Peter Taylor, MD 407-351-5384 Eps77797@gmail.com | |
| Contact: Lily Goul 407-625-7884 or 407-947-2297 Eps77797@gmail.com | |
| Principal Investigator: Peter Taylor, MD | |
| West Hospital Florida | Withdrawn |
| Pensacola, Florida, United States, 32514 | |
| Tallahassee Memorial Hospital | Recruiting |
| Tallahassee, Florida, United States, 32308 | |
| Contact: Farhat S Khairallah, MD 850-216-0100 patty.knap@tmh.org | |
| Contact: Patty Knap 850 431 5024 patty.knap@tmh.org | |
| Principal Investigator: Farhat S Khairallah | |
| Palm Beach Gardens Hospital | Withdrawn |
| Wellington, Florida, United States, 33449 | |
| United States, Georgia | |
| Piedmont Medical Center | Recruiting |
| Atlanta, Georgia, United States, 30309 | |
| Contact: Kristi Picardi, RN, CCRC 404-694-9754 kristi.picardi@piedmont.org | |
| Principal Investigator: Dan Dan, MD | |
| Veteran's Administration Medical Center | Recruiting |
| Atlanta, Georgia, United States, 30345 | |
| Contact: Jody Crouch jody.crouch@va.gov | |
| Principal Investigator: Heather Bloom, MD | |
| Emory University Hospital | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Deanna Hill 404-727-4939 dmhill@emory.edu | |
| Principal Investigator: Jonathan Langberg, MD | |
| Wellstar Kennestone Hospital | Recruiting |
| Marietta, Georgia, United States, 30060 | |
| Contact: Narendra Kanuru, MD 770-793-5975 jennifer.lacorte@wellstar.org | |
| Contact: Jennifer LaCorte 770-793-5975 jennifer.lacorte@wellstar.org | |
| Principal Investigator: Narendra Kanuru, MD | |
| United States, Illinois | |
| Trinity Medical Center | Recruiting |
| Rock Island, Illinois, United States, 61201 | |
| Contact: Cindy Antonio 309-779-2458 antonioc@IHS.org | |
| Principal Investigator: Helbert Acosta, MD | |
| St. John's Hospital | Recruiting |
| Springfield,, Illinois, United States, 62769 | |
| Contact: Danielle Kolakowski, RN 217-492-9100 Dkolakowski@prairieresearch.com | |
| Principal Investigator: Ziad Issa, MD | |
| United States, Indiana | |
| St. Mary's Medical | Recruiting |
| Hobart, Indiana, United States, 46342 | |
| Contact: Ravi Bhagwat, MD 219-931-8708 | |
| Contact: Cynthia Lopez 219-931-8708 clopez@canwi.com | |
| Principal Investigator: Ravi Bhagwat, MD | |
| Community Hospital, Munster | Recruiting |
| Munster, Indiana, United States, 46321 | |
| Contact: Dr. Arvind Ghandi, Ghandi 219-934-4200 | |
| Contact: Ricardo Guedes 219 934 4200 ext 225 rguedes@canni.com | |
| Principal Investigator: Arvind Gandhi, MD | |
| St. Margaret Mercy | Recruiting |
| Munster, Indiana, United States, 46321 | |
| Contact: Melissa Trott 219-947-6766 mtrott@comhs.org | |
| Principal Investigator: Raghuram Dasari, MD | |
| United States, Louisiana | |
| Burkett Heart Clinic | Recruiting |
| Monroe, Louisiana, United States, l | |
| Contact: J'Laine Jones 318-323-2328 burkettheart@gmail.com | |
| Principal Investigator: Scott Burkett, MD | |
| P & S Surgical | Recruiting |
| Monroe, Louisiana, United States, 71201 | |
| Contact: Dan O'Quain 318-791-2242 danoquain@pssurgery.com | |
| Principal Investigator: Assad Mouhaffel, MD | |
| United States, Maryland | |
| Johns Hopkins University Hospital | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| Contact: Charles A Henrikson, MD 443-287-3472 kavara1@jhmi.edu | |
| Contact: Kathleen Avara 410-502-5616 kavara1@jhmi.edu | |
| Principal Investigator: Charles A Henrikson, MD | |
| Harford Memorial Hospital | Withdrawn |
| Bel Air, Maryland, United States, 21014 | |
| Penninsula Regional Medical Center | Active, not recruiting |
| Salisbury, Maryland, United States, 21804 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02144 | |
| Contact: Elizabeth Kelly 617-726-5554 eakelly@partners.org | |
| Principal Investigator: Theofania Mela, MD | |
| University of Massachusetts Medical School | Recruiting |
| Worcester, Massachusetts, United States, 01655 | |
| Contact: Lawrence S Rosenthal, MD, PhD 508-334-0481 bridgett.monville@umassmed.edu | |
| Contact: Bridgett Monville 508-856-5953 bridgett.monville@umassmed.edu | |
| Principal Investigator: Lawrence S Rosenthal, MD, PhD | |
| United States, Michigan | |
| Henry Ford Health System | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Sandy Alexander 313-916-5494 salexan4@hfhs.org | |
| Principal Investigator: Claudio Schuger, MD | |
| Sparrow Hospital | Recruiting |
| Lansing, Michigan, United States, 48910 | |
| Contact: Tracey Zambon 517-483-7538 | |
| Principal Investigator: Ranjan K. Thakur, MD | |
| United States, Mississippi | |
| Keesler Air Force Base Hospital | Recruiting |
| Biloxi, Mississippi, United States, 39534 | |
| Contact: Sabrina Sumner, MD, Captain 904-505-9111 sabrina.sumner.1@us.af.mil | |
| Contact: Adam Ackerman, MD, Captain aadam.ackerman.3@us.af.mil | |
| Principal Investigator: Sabrina Sumner, MD | |
| Gulfport Memorial Hospital | Recruiting |
| Biloxi, Mississippi, United States, 39532 | |
| Contact: Paul E Mullen, MD 228-392-7429 cccresearch@cableone.net | |
| Contact: Sherry Raziano 228-392-7429 cccresearch@cableone.net | |
| Principal Investigator: Paul E Mullen, MD | |
| Southern Heart Center | Recruiting |
| Hattiesburg, Mississippi, United States, 39401 | |
| Contact: Eric W Enger, MD 601-268-5800 fraces.findley@hattiesburgclinic.com | |
| Contact: Frances Findley 601-268-5800 fraces.findley@hattiesburgclinic.com | |
| Principal Investigator: Eric W Enger, MD | |
| United States, Nebraska | |
| Alegent Health | Recruiting |
| Omaha, Nebraska, United States, 68124 | |
| Contact: Kent J Gleed, MD 402-960-8298 Marilyn.herbst@alegent.org | |
| Contact: Marilyn Herbst 402-343-8515 Marilyn.herbst@alegent.org | |
| Principal Investigator: Kent J Gleed, MD | |
| United States, New Jersey | |
| Englewood Hospital and Medical Center | Recruiting |
| Englewood, New Jersey, United States, 07631 | |
| Contact: Grant R Simons, MD 201-894-3533 | |
| Contact: Meryna Manandhar 201-894-3907 | |
| Principal Investigator: Grant R Simons, MD | |
| St. Francis Hospital | Terminated |
| Hamilton, New Jersey, United States, 08690 | |
| Newark Beth Israel Hospital | Recruiting |
| Newark, New Jersey, United States, 07112 | |
| Contact: Marc Roelke, MD 973-731-9598 dlovato@njcaheart.com | |
| Contact: Diane Lovato 973-877-5463 dlovato@njcaheart.com | |
| Principal Investigator: Marc Roelke, MD | |
| Valley Hospital | Recruiting |
| Ridgewood, New Jersey, United States, 07450 | |
| Contact: Mark W Preminger, MD 201-447-8261 ksayles@valleyhealth.com | |
| Contact: Kathleen Sayles 201-447-8261 ksayles@valleyhealth.com | |
| Principal Investigator: Mark W Preminger, MD | |
| Our Lady of Lourdes Hospital | Recruiting |
| Sewell, New Jersey, United States, 08080 | |
| Contact: Steven A Levi, MD 856-582-2000 ext 5207 mcoleferry@cadvhearthouse.com | |
| Contact: Michele Cole-Ferry 856-582-2000 ext 5243 mcoleferry@cadvhearthouse.com | |
| Principal Investigator: Steven A Levi, MD | |
| United States, New York | |
| St. Luke's - Roosevelt Hospital | Recruiting |
| New York, New York, United States, 10025 | |
| Contact: Suneet Mittal, MD 212-523-3281 AAlburo@chpnet.org | |
| Contact: Ammy Molinay 212-523-3281 AAlburo@chpnet.org | |
| Principal Investigator: Suneet Mittal, MD | |
| United States, North Carolina | |
| Carolinas Medical Center Northeast | Recruiting |
| Concord, North Carolina, United States, 28025 | |
| Contact: Janet Patterson 704-403-3000 Janet.Patterson@carolinashealthcare.org | |
| Principal Investigator: Thomas Christopher, MD | |
| Frye Regional Medical Center | Recruiting |
| Hickory, North Carolina, United States, 28601 | |
| Contact: Richard Schultz 828-261-0009 ext 290 aerwin@piedmontcardio.com | |
| Contact: Anne Erwin 828-261-0009 ext 290 aerwin@piedmontcardio.com | |
| Principal Investigator: Richard Schultz, MD | |
| United States, Ohio | |
| Catholic Health Partners | Recruiting |
| Youngstown, Ohio, United States, 44510 | |
| Contact: Wlater P Paladino, MD 330-744-2883 Dianalyn_Evans@hmis.org | |
| Contact: Diane Evans 330-480-3369 Dianalyn_Evans@hmis.org | |
| Principal Investigator: Walter P Paladino, MD | |
| United States, Pennsylvania | |
| Doylestown Hospital | Recruiting |
| Doylestown, Pennsylvania, United States, 18901 | |
| Contact: Robert M Sangrigoli, MD 215-345-6050 jmoore@cbspecialists.com | |
| Contact: Judy Moore, MD 215-345-6050 jmoore@cbspecialists.com | |
| Principal Investigator: Robert M Sangrigoli, MD | |
| Pinnacle Health Harrisburg Hospital | Recruiting |
| Harrisburg, Pennsylvania, United States, 17110 | |
| Contact: David L Scher, MD 717-920-4430 agerow@ac-pc.com | |
| Contact: Alice Gerow 717 920 4430 agerow@ac-pc.com | |
| Principal Investigator: David L Scher, MD | |
| University of Pittsburgh Medical Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Samir F Saba, MD 412-648-9701 mularskisa@upmc.edu | |
| Contact: Susan Mularski 412-648-9701 mularskisa@upmc.edu | |
| Principal Investigator: Samir F Saba, MD | |
| York Hospital | Recruiting |
| York, Pennsylvania, United States, 17403 | |
| Contact: Lyle Siddoway, MD 717-851-3472 | |
| Contact: Barbara Delio-Cox, RN 717-851-3472 bdeliocox@wellspan.org | |
| Principal Investigator: Lyle Siddoway, MD | |
| United States, Rhode Island | |
| Landmark Medical Center | Recruiting |
| Woonsocket, Rhode Island, United States, 02895 | |
| Contact: Hani M. Sabbour, MD 401-334-4929 asjedhussain@gmail.com | |
| Contact: Asjed Hussain 401 334 4929 asjedhussain@gmail.com | |
| Principal Investigator: Hani M. Sabbour, MD | |
| United States, Tennessee | |
| Stern Cardiovascular Foundation | Recruiting |
| Germantown, Tennessee, United States, 38138 | |
| Contact: Barbara Hamilton Barbara.hamilton@stemcardio.com | |
| Contact: Susan Bass Susan.bass@stemcardio.com | |
| Principal Investigator: Eric Johnson, MD | |
| University of TN Medical Center, Knoxville | Recruiting |
| Knoxville, Tennessee, United States | |
| Contact: Tiffany Skinner 865-246-7170 tskinner@mc.utmck.edu | |
| Principal Investigator: Jeffrey Hirsh, MD | |
| United States, Texas | |
| Texas Heart Institute - St. Luke's Episcopal Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Abdi Rasekh, MD 713-529-5530 mharlan54@gmail.com | |
| Contact: Mary Harlan 713-529-5530 mharlan54@gmail.com | |
| Principal Investigator: Abdi Rasekh, MD | |
| NE Methodist | Recruiting |
| San Antonio, Texas, United States, 78258 | |
| Contact: Roman Pachulski, MD 210-408-2343 Rtpach@mac.com | |
| Contact: Mary Pachulski, RN 210-364-1956 Mjpach@mac.com | |
| Principal Investigator: Roman Pachulski, MD | |
| United States, Wisconsin | |
| Aurora Health Care | Recruiting |
| Milwaukee, Wisconsin, United States, 53215 | |
| Contact: Ryan Cooley, MD 262-387-8200 | |
| Contact: Donald Lobacz, RN 414-649-3438 donald.lobacz@aurora.org | |
| Principal Investigator: Ryan Cooley, MD | |
| The Wisconsin Heart Hospital | Recruiting |
| Wauwatosa, Wisconsin, United States, 53226 | |
| Contact: Jane Schimke, AAS 414-389-3562 jane.schimke@wfhc.org | |
| Principal Investigator: Margot Vloka, MD | |
Sponsors and Collaborators
TYRX, Inc.
Investigators
| Study Director: | Daniel J. Lerner, MD | TYRX, Inc. |
More Information
No publications provided by TYRX, Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Daniel J. Lerner, MD / Chief Medical Officer, TYRX, Inc. |
| ClinicalTrials.gov Identifier: | NCT01043861 History of Changes |
| Other Study ID Numbers: | CP-2009-1 |
| Study First Received: | January 5, 2010 |
| Last Updated: | July 19, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by TYRX, Inc.:
|
Defibrillator infection ICD infection Cardiovascular implantable electronic device infection Infection Defibrillators |
Additional relevant MeSH terms:
|
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013