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NCT01426425 · ClinicalTrials.gov registry record · Phase 3
Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia
A Phase 3 study, sponsored by Medtronic Cardiac Ablation Solutions.
- Completed
- Registry status
- Phase 3
- Development phase
- 572
- Enrollment target
NCT01426425: Completed Phase 3 study, sponsored by Medtronic Cardiac Ablation Solutions.
NCT01426425 is a Phase 3 study that has completed, run by Medtronic Cardiac Ablation Solutions. The registered enrollment target is 572 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01426425, a Phase 3 study, has completed, sponsored by Medtronic Cardiac Ablation Solutions.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 572 participants
- Enrollment target
Study 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.
Primary Outcome
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-u
Interventions
- DEVICE Freezor Xtra Cryoablation Catheter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 572 participants |
| Start Date | 2012-05 |
| Est. Completion | 2016-09 |
| Phase | Phase 3 |
What the finished NCT01426425 record still lists
NCT01426425 is an interventional study that assigns participants to a tested intervention. The registered 572 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 1 intervention - of which Freezor Xtra Cryoablation Catheter is the first listed.
NCT01426425 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01426425 about?
NCT01426425 is a clinical study titled "Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia". 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® Xt...
What is the current status of trial NCT01426425?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 572 participants. The study started on 2012-05. Estimated completion is 2016-09.
What interventions are being tested in trial NCT01426425?
The interventions under investigation include: Freezor Xtra Cryoablation Catheter (DEVICE).
Who is sponsoring clinical trial NCT01426425?
This trial is sponsored by Medtronic Cardiac Ablation Solutions, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01426425's enrollment target sits among peer trials
572 663rd of 2000 higher than 1,336 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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