CARTO® 3 System and Real Time Intracardiac Ultrasound (IUAF)
This study is currently recruiting participants.
Verified February 2013 by Biosense Webster, Inc.
Sponsor:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01716663
First received: October 19, 2012
Last updated: April 30, 2013
Last verified: February 2013
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Purpose
This is a prospective, multicenter, non-randomized observational study of subjects 18 years and older undergoing RF ablation with drug refractory recurrent symptomatic paroxysmal Atrial Fibrillation (AF).
| Condition | Intervention |
|---|---|
|
Atrial Fibrillation Paroxysmal AF |
Device: Catheter Ablation |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | CARTO® 3 System and Real Time Intracardiac Ultrasound for Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal AF: Acute Procedural Outcomes Study |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
U.S. FDA Resources
Further study details as provided by Biosense Webster, Inc.:
Primary Outcome Measures:
- Fluoroscopy Time [ Time Frame: Day 0 ] [ Designated as safety issue: No ]The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure.
Secondary Outcome Measures:
- Procedure Time [ Time Frame: Day 0 ] [ Designated as safety issue: No ]The procedure time will be measured for each phase (access, mapping, ablation, and validation) of the procedure.
- Acute Success [ Time Frame: Day 0 ] [ Designated as safety issue: No ]Acute success will be measured via confirmation of pulmonary vein isolation method.
- Safety [ Time Frame: Within 7 days of the procedure ] [ Designated as safety issue: Yes ]Procedural complications, electrocardiogram abnormalities and adverse events.
- Number of Radiofrequency (RF) Applications [ Time Frame: Day 0 ] [ Designated as safety issue: No ]RF application will be measured by number of times delivered during the procedure.
- Total Radiofrequency (RF) Time [ Time Frame: Day 0 ] [ Designated as safety issue: No ]Total RF time will be measured for the total time RF is delivered during the procedure.
| Estimated Enrollment: | 500 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Experimental: Catheter Ablation
These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.
|
Device: Catheter Ablation
NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)
Other Name: CARTO® 3 System and Real Time Intracardiac Ultrasound
|
Detailed Description:
This study is purposed to measure "real world" acute procedural outcomes (procedural efficiency and acute safety) associated with use of the CARTO® 3 System and real time intracardiac ultrasound in a clinical setting in subjects with drug refractory recurrent symptomatic paroxysmal AF.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects 18 years and older with drug refractory recurrent symptomatic paroxysmal AF
Criteria
Inclusion Criteria:
- Drug refractory, recurrent symptomatic paroxysmal AF
- Age 18 years or older
- Patients able and willing to provide written informed consent to participate in the study and comply with study requirements
Exclusion Criteria:
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- Previous ablation for atrial fibrillation
- AF episodes that last longer than 30 days
- Uncontrolled heart failure, or NYHA Class III or IV heart failure
- Documented intra-atrial thrombus or other abnormality on pre-ablation imaging
- Contraindication to anticoagulation
- Stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months
- Awaiting cardiac transplantation
- Heart disease for which corrective surgery is anticipated within 6 months
- Enrollment in other investigational drug or device study
- Subjects unwilling to comply with protocol or follow-up requirements
- Patients who are pregnant
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716663
Contacts
| Contact: Timothy Hentges | 623-326-4343 | thentges@its.jnj.com |
| Contact: Jamie March | 909-839-8543 | jmarch1@its.jnj.com |
Locations
| United States, Arizona | |
| AZ Heart Rhythm Center | Recruiting |
| Phoenix, Arizona, United States, 85006 | |
| Contact: Wendy Schwoegler, BS 480-659-7583 | |
| Principal Investigator: Vijendra Swarup, MD | |
| Clinical Research Advantage, Inc. | Recruiting |
| Phoenix, Arizona, United States, 85015 | |
| Contact: Brigit Iles 602-824-9510 bjiels@crastudies.com | |
| Principal Investigator: Kishlay Anand, MD | |
| United States, California | |
| Good Samaritan Hospital | Not yet recruiting |
| Los Angeles, California, United States, 90017 | |
| Contact: Lisa Fletcher 408-559-2374 lisa.fletcher1@hcahealthcare.com | |
| Contact: Lori Henry 408-559-2374 lori.henry@hcahealthcare.com | |
| Principal Investigator: Ivan Ho | |
| Santa Barbara Cottage Hospital | Recruiting |
| Santa Barbara, California, United States, 93105 | |
| Contact: Samantha Yim 805-569-7461 syim@sbch.org | |
| Principal Investigator: Brett Gidney | |
| United States, Colorado | |
| Colorado Cardiac Alliance, LLC | Not yet recruiting |
| Colorado Springs, Colorado, United States, 80907 | |
| Contact: Susan Stoddard 719-634-6671 sstoddard@cscardiologist.com | |
| Principal Investigator: Christopher Cole, MD | |
| United States, Florida | |
| JFK Medical Center | Recruiting |
| Atlantis, Florida, United States, 33462 | |
| Contact: Donalyn Lamarre 561-548-1735 donalyn.lamarre@hcahealthcare.com | |
| Principal Investigator: Robert Fishel, MD | |
| Tallahassee Resesarch Institute, Inc. | Recruiting |
| Tallahassee, Florida, United States, 32308 | |
| Contact: Patty Knap 850-431-5024 patty.knap@tmh.org | |
| Contact: Sharon Liebrich | |
| Principal Investigator: Farhat Khairallah, MD | |
| United States, Illinois | |
| Provena Saint Joseph Medical Center | Recruiting |
| Joliet, Illinois, United States, 60435 | |
| Contact: Laura Paganessi 815-773-7031 laura.paganessi@presencehealth.org | |
| Principal Investigator: Ahmad Jones, MD | |
| United States, Ohio | |
| MediSync Clinical Research | Recruiting |
| Cincinnati, Ohio, United States, 45212 | |
| Contact: Jeff Repper 513-533-6514 jeff.repper@medisync.com | |
| Principal Investigator: Shahid Baig, MD | |
| United States, Pennsylvania | |
| Geisinger Wyoming Valley Medical Center | Recruiting |
| Danville, Pennsylvania, United States, 17822 | |
| Contact: Lori Scalzo 570-808-6382 lmscalzo1@geisinger.edu | |
| Principal Investigator: Gopi Dandamudi, MD | |
| St. Mary Medical Center | Recruiting |
| Langhorne, Pennsylvania, United States, 19047 | |
| Contact: Miki Haas 215-710-4510 mhaas@st.maryhealthcare.org | |
| Principal Investigator: Scott Burke, MD | |
| ARIA Health | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19114 | |
| Contact: Jane Slaterback 267-350-3136 Janeslaterbeck@ariahealth.org | |
| Principal Investigator: Bradley Bacik, MD | |
| Hospital of the University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 17104 | |
| Contact: David Phuong 215-615-0186 david.phuong@uphs.upenn.edu | |
| Principal Investigator: Mathew Hutchinson, MD | |
| Lankenau Institute for Medical Research | Not yet recruiting |
| Wynnewood, Pennsylvania, United States, 19096 | |
| Contact: Lisa Thome 484-476-8570 thomel@mlhs.org | |
| Principal Investigator: Douglas Esberg, MD | |
| United States, Tennessee | |
| Wellmont CVA Heart Institute | Recruiting |
| Kingsport, Tennessee, United States, 37660 | |
| Contact: Ashley Sparks 423-230-5062 asparks@mycva.com | |
| Principal Investigator: Gregory Jones, MD | |
| United States, Texas | |
| Scott & White Memorial Hospital | Recruiting |
| Temple, Texas, United States, 76508 | |
| Contact: Stephanie Blue 254-724-5373 slblue@sw.org | |
| Principal Investigator: David Fitzgerald, MD | |
| United States, Utah | |
| McKay Dee Hospital | Not yet recruiting |
| Ogden, Utah, United States, 84403 | |
| Contact: Staci Gola Staci.Gola@imail.org | |
| Contact: Jesse Whitfield 801-408-1729 Jesse.Whitfield@imail.org | |
| Principal Investigator: Michael Eifling, MD | |
| United States, Virginia | |
| Sentara Norfolk General Hospital | Recruiting |
| Norfolk, Virginia, United States, 23507 | |
| Contact: Linette Klevan 757-388-2425 lrklevan@sentara.com | |
| Principal Investigator: Philip Gentlesk | |
| United States, Wisconsin | |
| Medical College of Wisconsin | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Susan Mauermann 414-955-6749 smauerma@mcw.edu | |
| Principal Investigator: Marcie Berger, MD | |
Sponsors and Collaborators
Biosense Webster, Inc.
Investigators
| Principal Investigator: | Vijendra Swarup, MD | AZ Heart Rhythm Center |
More Information
No publications provided
| Responsible Party: | Biosense Webster, Inc. |
| ClinicalTrials.gov Identifier: | NCT01716663 History of Changes |
| Other Study ID Numbers: | IUAF |
| Study First Received: | October 19, 2012 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Biosense Webster, Inc.:
|
Symptomatic paroxysmal Atrial fibrillation Observational Acute procedural outcomes Ablation |
Additional relevant MeSH terms:
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 17, 2013