Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia
This study is currently recruiting participants.
Verified January 2013 by Medtronic Atrial Fibrillation Solutions
Sponsor:
Medtronic Atrial Fibrillation Solutions
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT01426425
First received: August 29, 2011
Last updated: February 12, 2013
Last verified: January 2013
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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
Show 32 Study Locations
Contacts
| Contact: Lori Rusch, PhD | (763) 526-2843 | lori.k.rusch@medtronic.com |
| Contact: Linda Nelson | (763) 526-2891 | linda.k.nelson@medtronic.com |
Show 32 Study LocationsSponsors 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 12, 2013 |
| 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 16, 2013