Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia

This study is currently recruiting participants.
Verified March 2014 by Medtronic Atrial Fibrillation Solutions
Sponsor:
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT01426425
First received: August 29, 2011
Last updated: March 13, 2014
Last verified: March 2014
  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

Contacts
Contact: Adam M Cline, MD, MSc (763) 526-9601 adam.cline@medtronic.com
Contact: William C Prather (763) 514-9897 william.c.prather@medtronic.com

  Hide Study Locations
Locations
United States, Arizona
Heart Rhythm Specialists of Arizona Withdrawn
Phoenix, Arizona, United States, 85013
United States, Arkansas
Cardiology Associates of Northeast Arkansas Withdrawn
Jonesboro, Arkansas, United States, 72401
United States, California
Santa Barbara Cottage Hospital Recruiting
Santa Barbara, California, United States, 93105
Contact: Sharon Granoff    805-569-7461    sgranoff@sbch.org   
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 Recruiting
Miami, Florida, United States, 33176
Contact: Ivette Cruz    786-596-4746    IvetteC@baptisthealth.net   
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 Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Linda Briggs    734-232-5022    briggsl@umich.edu   
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: Dalena Hervias    718-920-5733    Dahervia@montefiore.org   
Principal Investigator: Andrew Krumerman, MD         
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: David Pinto    585-273-4460    DavidJ_Pinto@urmc.rochester.edu   
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, Rhode Island
Rhode Island Hospital Not yet recruiting
Providence, Rhode Island, United States, 02903
Principal Investigator: Antony Chu, MD         
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         
St. Luke's Episcopal Recruiting
Houston, Texas, United States, 77030
Contact: Gilberto De Freitas    832-355-3710    gdefreitas@sleh.com   
Principal Investigator: John Seger, 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         
United States, Wisconsin
Bellin Memorial Not yet recruiting
Green Bay, Wisconsin, United States, 54301
Principal Investigator: Vijaya Munagala, 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, Ontario
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada, N6A 5B9
Principal Investigator: Allan Skanes, 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 Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Ann Langlois    514-338-2222    A-Langlois@crhsc.rtss.qc.ca   
Principal Investigator: Marcio Sturmer, MD         
McGill University Health Centre Not yet recruiting
Montreal, Quebec, Canada, H3G 1A4
Principal Investigator: Martin Bernier, 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         
Canada, Saskatchewan
Prairie CardioVascular Research Network Not yet recruiting
Regina, Saskatchewan, Canada, S4P OW5
Principal Investigator: Omar Sultan, 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: March 13, 2014
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 April 17, 2014