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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01426425
Other study ID # ICY-AVNRT
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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