Clinical trial NCT01426425: Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia
Official title: ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: AtrioVentricular Nodal Reentrant Tachycardia
Supraventricular Tachycardia
Heart Disease
Keywords: Cardiac cryoablation
AVNRT
heart disease
tachycardia
AtrioVentricular Nodal Reentrant Tachycardia
Supraventricular tachycardia
SVT
Lead sponsor: Medtronic Cardiac Ablation Solutions
Sponsor class: INDUSTRY
First posted: 2011-08-31
Enrollment: 572
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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)

Primary outcomes:
measure: Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT Using an Endocardial Approach.
timeFrame: 6 months
measure: Chronic Safety (Through 6 Months) of the Freezor Xtra Catheter When Used for the Treatment of AVNRT Using an Endocardial Approach.
timeFrame: 6 Months
Secondary outcomes:
measure: Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT in Subjects Who Achieved Acute Procedural Success.
timeFrame: 6 Months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Good Samaritan Medical Center
state: Arizona
city: Santa Monica
country: United States
facility: Pacific Heart Institute
state: California
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Saint Louis Park
country: United States
facility: Park Nicollet Institute
state: Minnesota
city: Saint Paul
country: United States
facility: Healtheast St. Joseph's Hospital
state: Minnesota
city: Bay Shore
country: United States
facility: Southside Hospital
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Charlotte
country: United States
facility: Sanger Heart and Vascular Institute
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Dayton
country: United States
facility: Miami Valley Cardiologists
state: Ohio
city: Springfield
country: United States
facility: Sacred Heart Medical Center
state: Oregon
city: Camp Hill
country: United States
facility: Capital Cardiovascular Associates
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley Medical Center
state: Pennsylvania
city: Kingsport
country: United States
facility: Wellmont Cardiovascular Heart Institute
state: Tennessee
city: Dallas
country: United States
facility: Baylor Heart and Vascular Hospital
state: Texas
city: Houston
country: United States
facility: St. Luke's Episcopal
state: Texas
city: Plano
country: United States
facility: Baylor Research Institute
state: Texas
city: Falls Church
country: United States
facility: Virginia Heart
state: Virginia
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Victoria
country: Canada
facility: Victoria Cardiac Arrhythmia Trials, Inc.
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montreal
country: Canada
facility: Hopital du Sacre Coeur de Montreal
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Regina
country: Canada
facility: Prairie CardioVascular Research Network
state: Saskatchewan
Study officials:
affiliation: Baylor Univ Medical Ctr Dallas, TX.
name: Peter Wells, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wells P, Dubuc M, Klein GJ, Dan D, Roux JF, Lockwood E, Sturmer M, Dunbar D, Novak P, Rao A, Peterson BJ, Kueffer F, Ellenbogen KA; ICY-AVNRT Investigators. Intracardiac ablation for atrioventricular nodal reentry tachycardia using a 6 mm distal electrode cryoablation catheter: Prospective, multicenter, North American study (ICY-AVNRT STUDY). J Cardiovasc Electrophysiol. 2018 Jan;29(1):167-176. doi: 10.1111/jce.13367. Epub 2017 Nov 10.