Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia
This study is currently recruiting participants.
Verified January 2013 by Medtronic Atrial Fibrillation Solutions
Sponsor:
Medtronic Atrial Fibrillation Solutions
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT01426425
First received: August 29, 2011
Last updated: February 12, 2013
Last verified: January 2013
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Purpose
ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia) is a prospective multi-center, nonrandomized, single arm, controlled, unblinded, investigational clinical study. The purpose of this clinical study is to demonstrate the safety and effectiveness of the Freezor® Xtra Cardiac CryoAblation Catheter for the cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia (AVNRT) using an endocardial approach.
| Condition | Intervention | Phase |
|---|---|---|
|
AtrioVentricular Nodal Reentrant Tachycardia Supraventricular Tachycardia Heart Disease |
Device: Freezor Xtra Cryoablation Catheter |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia) |
Resource links provided by NLM:
Further study details as provided by Medtronic Atrial Fibrillation Solutions:
Primary Outcome Measures:
- Number of Participants with Successful Procedures and No AtrioVentricular Nodal Reentrant Tachycardia Recurrence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Subjects must meet both of the following conditions to be considered as a chronic effectiveness success:
- The inability to induce more than one echo beat by the same pacing maneuvers that induced atrioventricular nodal reentrant tachycardia (AVNRT) before cryoablation (with drug provocation if required for induction before cryoablation) at the conclusion of the ablation procedure assessment (i.e. acute procedural success)
- Lack of documented recurrence of clinical AVNRT during the 6 months follow-up period post the successful ablation procedure
- Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 6 Months ] [ Designated as safety issue: No ]The primary safety endpoint is a success/failure variable calculated for each subject through 6 months follow-up. Subjects with at least one chronic safety event (serious adverse event determined to be ablation procedure or device related) during the cryoablation procedure and through the end of 6 months follow-up will be considered a primary safety failure.
Secondary Outcome Measures:
- Number of Participants who had Acutely Successful Procedures and No Atrioventricular Nodal Reentrant Tachycardia Recurrence. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]Demonstrate the chronic effectiveness (Lack of documented recurrence of clinical atrioventricular nodal reentrant tachycardia) of the Freezor® Xtra CryoAblation Catheter in the treatment of atrioventricular nodal reentrant tachycardia through 6 months in subjects who have achieved acute procedural success.
| Estimated Enrollment: | 850 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | February 2017 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cryoablation
Subjects diagnosed with atrioventricular nodal reentrant tachycardia and treated by cryoablation with Freezor Xtra.
|
Device: Freezor Xtra Cryoablation Catheter
Freezor® Xtra Cardiac CryoAblation applied for cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia using an endocardial approach.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Pre-Electrophysiology Study Inclusion Criteria:
- Supraventricular tachycardia (SVT) compatible with atrioventricular nodal reentrant tachycardia (AVNRT), documented by ECG, TTM, Holter or event monitor
Pre-Electrophysiology Study Exclusion Criteria:
- History of sustained (≥30 seconds) of ventricular tachycardia
- Atrial tachycardia or other arrhythmia that could be confused with AVNRT
- Reversible cause of SVT
- History of previous AVNRT ablation
- Therapy with amiodarone within last 90 days
- Unstable angina/myocardial infarction/open heart surgery in past 60 days
- New York Heart Association (NYHA) Classification III or IV currently or within the past 90 days
- Implantable cardiac rhythm device
- Atrioventricular block (first degree (PR interval ≥ 220ms), second degree, or third degree) or left bundle branch block
- Stroke or transient ischemic attack within the past 180 days
- Life expectancy less than 12 months
- Female known to be pregnant
- Unable/unwilling to give informed consent
- Unable/unwilling to comply with follow-up visits and study requirements
- Less than 18 years of age
- Active systemic infection
- Cryoglobulinemia
- Other conditions where the manipulation of the catheter would be unsafe (for example, intracardiac mural thrombus)
- Participating in a concurrent clinical study that may confound the results of this study
Post-Electrophysiology Study Inclusion Criteria:
- Subject must have one electrophysiology study documented inducible sustained (greater than or equal to 15 seconds) supraventricular tachycardia that is classified as AVNRT.
Post-Electrophysiology Study Exclusion Criteria:
- Presence of a second inducible arrhythmia that could be confused with AVNRT during follow-up or will likely result in ablation within the next 6 months
- Presence of inducible sustained ventricular tachycardia or fibrillation
- Presence of an accessory pathway
- Presence of abnormal conduction or refractoriness parameters of the atrioventricular conduction system.
- Indication for a pacemaker, defibrillator or cardiac resynchronization therapy (CRT)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426425
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Contacts
| Contact: Lori Rusch, PhD | (763) 526-2843 | lori.k.rusch@medtronic.com |
| Contact: Linda Nelson | (763) 526-2891 | linda.k.nelson@medtronic.com |
Hide Study LocationsLocations
| United States, Arizona | |
| Heart Rhythm Specialists of Arizona | Not yet recruiting |
| Phoenix, Arizona, United States, 85013 | |
| Principal Investigator: Wilber Su, MD | |
| United States, Arkansas | |
| Cardiology Associates of Northeast Arkansas | Withdrawn |
| Jonesboro, Arkansas, United States, 72401 | |
| United States, California | |
| Santa Barbara Cottage Hospital | Not yet recruiting |
| Santa Barbara, California, United States, 93105 | |
| Principal Investigator: Claudio Bonometti, MD | |
| Pacific Heart Institute | Recruiting |
| Santa Monica, California, United States, 90404 | |
| Contact: Crystal Ducharme 310-829-7678 cducharme@pacificheart.com | |
| Principal Investigator: Shepal Doshi, MD | |
| Stanford Hospital and Clinics | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Linda Norton 650-725-5597 lnorton@Stanfordmed.org | |
| Principal Investigator: Paul Wang, MD | |
| United States, Florida | |
| Baptist Hospital of Miami | Not yet recruiting |
| Miami, Florida, United States, 33176 | |
| Principal Investigator: Efrain Gonzalez, MD | |
| Orlando Heart Center | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Erin Martin 321-843-1037 Erin.Martin@orlandohealth.com | |
| Principal Investigator: Roland Filart, MD | |
| United States, Georgia | |
| Piedmont Heart Institute | Recruiting |
| Atlanta, Georgia, United States, 30309 | |
| Contact: Tasha Futch-Domohowski 404-605-2371 Tasha.Futch-Domohowski@piedmont.org | |
| Principal Investigator: Andrew Wickliffe, MD | |
| United States, Illinois | |
| Advocate Christ Medical Center | Recruiting |
| Oak Lawn, Illinois, United States, 60453 | |
| Contact: Charity Ball 708-684-4647 charity.ball@advocatehealth.com | |
| Principal Investigator: Manoj Duggal, MD | |
| United States, Iowa | |
| Iowa Heart Center | Recruiting |
| Des Moines, Iowa, United States, 50314 | |
| Contact: Cecily Decklever 515-633-3843 Cdecklever@iowaheart.com | |
| Principal Investigator: Robert Hoyt, MD | |
| United States, Michigan | |
| University of Michigan Medical Center | Not yet recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Principal Investigator: Frank Pelosi, MD | |
| United States, Minnesota | |
| Park Nicollet Institute | Recruiting |
| St. Louis Park, Minnesota, United States, 55426 | |
| Contact: Meaghan Morton 952-993-2066 meaghan.morton@parknicollet.com | |
| Principal Investigator: Hongsheng Guo, MD | |
| Healtheast St. Joseph's Hospital | Recruiting |
| St. Paul, Minnesota, United States, 55102 | |
| Contact: Joy Gilliam 651-471-2653 jegilliam@healtheast.org | |
| Principal Investigator: David Dunbar, MD | |
| United States, New York | |
| Montefiore Medical Center | Recruiting |
| Bronx, New York, United States, 10467 | |
| Contact: Faraj Al Qaraghuli 718-904-2624 falqara@montefiore.org | |
| Principal Investigator: Andrew Krumerman, MD | |
| University of Rochester Medical Center | Not yet recruiting |
| Rochester, New York, United States, 14642 | |
| Principal Investigator: David Huang, MD | |
| United States, North Carolina | |
| Sanger Heart and Vascular Institute | Recruiting |
| Charlotte, North Carolina, United States, 28203 | |
| Contact: Connie Dellinger 704-355-4795 connie.dellinger@carolinashealthcare.org | |
| Principal Investigator: John Holshouser, MD | |
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Brian Strippy 216-444-0379 STRIPPB@ccf.org | |
| Principal Investigator: Patrick Tchou, MD | |
| Miami Valley Cardiologists | Recruiting |
| Dayton, Ohio, United States, 45409 | |
| Contact: Ralf Mohr 937-208-4878 rhmohr@mvh.org | |
| Principal Investigator: Mark Krebs, MD | |
| United States, Oregon | |
| Sacred Heart Medical Center | Recruiting |
| Springfield, Oregon, United States, 97477 | |
| Contact: Becky Hammerschmith 541-510-9308 bhammerschmith@peacehealth.org | |
| Principal Investigator: Ramakota Reddy, MD | |
| United States, Pennsylvania | |
| Capital Cardiovascular Associates | Recruiting |
| Camp Hill, Pennsylvania, United States, 17011 | |
| Contact: Joanna Stuck 717-724-6450 joanna.stuck@hsh.org | |
| Principal Investigator: Safwat Gassis, MD | |
| Geisinger Medical Center | Recruiting |
| Danville, Pennsylvania, United States, 17822 | |
| Contact: Marisa Eccker 570-271-8049 meeccker@geisinger.edu | |
| Contact: Lori Scalzo 570-808-6382 lmscalzo1@geisinger.edu | |
| Principal Investigator: Randle Storm, MD | |
| Reading Hospital and Medical Center | Terminated |
| West Reading, Pennsylvania, United States, 19611 | |
| United States, Tennessee | |
| Wellmont Cardiovascular Heart Institute | Recruiting |
| Kingsport, Tennessee, United States, 37660 | |
| Contact: Ashley Sparks 423-230-5062 asparks@mycva.com | |
| Principal Investigator: Arun Rao, MD | |
| United States, Texas | |
| Baylor Heart and Vascular Hospital | Recruiting |
| Dallas, Texas, United States, 75226 | |
| Contact: Cathy Headley 214-841-2026 cathyhe@baylorhealth.edu | |
| Principal Investigator: Manish Assar, MD | |
| Leachman Cardiology | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: J. Alberto Lopez, MD | |
| Baylor Research Institute | Recruiting |
| Plano, Texas, United States, 75093 | |
| Contact: Amy Barnette 469-814-4737 amy.barnette@baylorhealth.edu | |
| Principal Investigator: Thomas Beveridge, MD | |
| United States, Virginia | |
| Virginia Heart | Recruiting |
| Falls Church, Virginia, United States, 22042 | |
| Contact: Deanna Overbeck 703-766-5920 doverbeck@tcg.md | |
| Principal Investigator: Haroon Rashid, MD | |
| Canada, Alberta | |
| Royal Alexandra Hospital | Recruiting |
| Edmonton, Alberta, Canada, T5H 3V9 | |
| Contact: Sylvia Martin (780) 735-4489 Sylvia.Martin@albertahealthservices.ca | |
| Principal Investigator: Evan Lockwood, MD | |
| Canada, British Columbia | |
| Victoria Cardiac Arrhythmia Trials, Inc. | Recruiting |
| Victoria, British Columbia, Canada, V8R 4R2 | |
| Contact: Mona Bastell (250) 595-0400 mbastell@catrials.org | |
| Principal Investigator: Paul Novak, MD | |
| Canada, Quebec | |
| Montreal Heart Institute | Recruiting |
| Montreal, Quebec, Canada, H1T 1C8 | |
| Contact: Evelyn Landry Evelyn.Landry@icm-mhi.org | |
| Principal Investigator: Marc Dubuc, MD | |
| Hopital du Sacre Coeur de Montreal | Not yet recruiting |
| Montreal, Quebec, Canada, H3A 1A1 | |
| Principal Investigator: Marcio Sturmer, MD | |
| Centre Hospitalier Universitaire de Sherbrooke | Recruiting |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| Contact: Stephanie Cote (819) 346-1110 sacote.chus@ssss.gouv.qc.ca | |
| Principal Investigator: Jean-Francois Roux, MD | |
Sponsors and Collaborators
Medtronic Atrial Fibrillation Solutions
Investigators
| Principal Investigator: | Peter Wells, M.D. | Baylor Univ Medical Ctr Dallas, TX. |
More Information
No publications provided
| Responsible Party: | Medtronic Atrial Fibrillation Solutions |
| ClinicalTrials.gov Identifier: | NCT01426425 History of Changes |
| Other Study ID Numbers: | ICY-AVNRT |
| Study First Received: | August 29, 2011 |
| Last Updated: | February 12, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board Canada: Ethics Review Committee |
Keywords provided by Medtronic Atrial Fibrillation Solutions:
|
Cardiac cryoablation AVNRT heart disease tachycardia |
AtrioVentricular Nodal Reentrant Tachycardia Supraventricular tachycardia SVT |
Additional relevant MeSH terms:
|
Heart Diseases Tachycardia Tachycardia, Atrioventricular Nodal Reentry Tachycardia, Supraventricular |
Cardiovascular Diseases Arrhythmias, Cardiac Pathologic Processes Tachycardia, Reciprocating |
ClinicalTrials.gov processed this record on May 22, 2013