Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia - Full Text View

Sponsor:	Medtronic Atrial Fibrillation Solutions
Information provided by (Responsible Party):	Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:	NCT01426425

Purpose

ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia (AVNRT))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
AVNRT AtrioVentricular Nodal Reentrant Tachycardia SVT Supraventricular Tachycardia Heart Disease	Device: Medtronic Freezor Xtra Cardiac 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:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Heart Diseases

U.S. FDA Resources

Further study details as provided by Medtronic Atrial Fibrillation Solutions:

Primary Outcome Measures:

Freezor(R) Extra Chronic effectiveness (through 6 months)for the treatment of AVNRT (AVNRT: Atrioventricular nodal reentrant tachycardia) [ 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 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
Freezor(R) Extra Chronic safety (through 6 months)for the treatment of AVNRT [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
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:

Freezor(R) Extra Chronic effectiveness (through 6 months)for the treatment of AVNRT in subjects who have achieved acute procedural success. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Demonstrate the chronic effectiveness (Lack of documented recurrence of clinical AVNRT) of the Freezor® Xtra CryoAblation Catheter in the treatment of AVNRT 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	Device: Medtronic Freezor Xtra Cardiac Cryoablation Catheter Freezor® Xtra Cardiac CryoAblation applied in the cryoablation of the conducting tissues of the heart in the treatment of patients with AVNRT using an endocardial approach.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Pre-EP Study Inclusion Criteria:

SVT compatible with AVNRT, Documented by ECG, TTM, Holter or event monitor

Pre-EP 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
NYHA Classification III or IV currently or within the past 90 days
Implantable cardiac rhythm device
Atrioventricular block (1° (PR interval ≥ 220ms), 2°, 3°) 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
< 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-EP Study Inclusion Criteria:

Subject must have one EPS-documented inducible sustained (≥ 15 seconds) supraventricular tachycardia that is classified as AVNRT.

Post-EP 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 CRT

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426425

Contacts

Contact: Lori Rusch, PhD	(763) 526-2843	lori.k.rusch@medtronic.com
Contact: Robert Spencer	(763) 505-8690	robert.j.spencer@medtronic.com

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 28, 2012
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 23, 2012