Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia

Heart Disease Clinical Trial

Official title:

ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01426425
• Other study ID #: ICY-AVNRT
• Status: Completed
• Phase: Phase 3
• Start date: May 2012
• Est. completion date: September 2016

Study information

• Verified date: September 2018
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 572
• Est. completion date: September 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• AtrioVentricular Nodal Reentrant Tachycardia
• Heart Disease
• Heart Diseases
• Supraventricular Tachycardia
• Tachycardia
• Tachycardia, Atrioventricular Nodal Reentry
• Tachycardia, Supraventricular

Intervention

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.

Locations

Country	Name	City	State
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	London Health Sciences Centre	London	Ontario
Canada	Hopital du Sacre Coeur de Montreal	Montreal	Quebec
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Prairie CardioVascular Research Network	Regina	Saskatchewan
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	Victoria Cardiac Arrhythmia Trials, Inc.	Victoria	British Columbia
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Southside Hospital	Bay Shore	New York
United States	Montefiore Medical Center	Bronx	New York
United States	Capital Cardiovascular Associates	Camp Hill	Pennsylvania
United States	Sanger Heart and Vascular Institute	Charlotte	North Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	Baylor Heart and Vascular Hospital	Dallas	Texas
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Miami Valley Cardiologists	Dayton	Ohio
United States	Iowa Heart Center	Des Moines	Iowa
United States	Virginia Heart	Falls Church	Virginia
United States	St. Luke's Episcopal	Houston	Texas
United States	Wellmont Cardiovascular Heart Institute	Kingsport	Tennessee
United States	Baptist Hospital of Miami	Miami	Florida
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Orlando Regional Medical Center	Orlando	Florida
United States	Banner Good Samaritan Medical Center	Phoenix	Arizona
United States	Baylor Research Institute	Plano	Texas
United States	University of Rochester Medical Center	Rochester	New York
United States	Park Nicollet Institute	Saint Louis Park	Minnesota
United States	Healtheast St. Joseph's Hospital	Saint Paul	Minnesota
United States	Pacific Heart Institute	Santa Monica	California
United States	Sacred Heart Medical Center	Springfield	Oregon
United States	Stanford Hospital and Clinics	Stanford	California
United States	Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT Using an Endocardial Approach.	Subjects must have met both of the following acute and chronic conditions to be considered a chronic effectiveness (treatment) success: Acute Success: The inability to induce more than one echo beat by the same pacing maneuvers that induced AVNRT before cryoablation (with drug provocation if required for induction before cryoablation) at the conclusion of the study cryoablation procedure assessment.; Chronic Success: Lack of documented recurrence of clinical AVNRT during the 6-month follow-up period after the study cryoablation procedure.	6 months
Primary	Chronic Safety (Through 6 Months) of the Freezor Xtra Catheter When Used for the Treatment of AVNRT Using an Endocardial Approach.	Subjects who had at least one safety event during or after their cryoablation procedure or through 6 months of follow-up are considered a primary (chronic) safety failure. A safety event is defined as the occurrence of any adverse event that is adjudicated by the AE Adjudication Committee as being serious and study ablation procedure-related and/or Freezor Xtra Catheter related that: 1) Resulted in death, 2) Resulted in a life-threatening illness or injury, 3) Resulted in permanent impairment of a body function or permanent damage to a body structure, 4) Necessitated significant intervention, such as major surgery or even intravenous medical therapy (e.g., vasopressors), to prevent permanent impairment of a body function or permanent damage to a body structure, or 5) Required in-patient hospitalization or a prolongation of an existing hospital stay.	6 Months
Secondary	Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT in Subjects Who Achieved Acute Procedural Success.	If there was no documented evidence of AVNRT recurrence in the post-procedure 6-month follow-up period, the subject is counted as a chronic effectiveness success. The AE Adjudication Committee adjudication of AVNRT recurrence is used to classify subjects for this endpoint.	6 Months