CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 348 enrolled
Drug / intervention
Pulmonary Vein Isolationprocedure
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01913522
NCT01913522N/ACompleted

Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: The Effect of Double Short vs. Standard Exposure Cryoablation Duration During Pulmonary Vein Isolation.

University of British Columbia·interventional·Posted Aug 1, 2013·Updated May 7, 2019

In Brief

A clinical study evaluating Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation. Completed, enrolled 348 participants across 1 site.

Detailed Summary

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and is associated with reductions in quality of life, functional status, cardiac performance, and overall survival.1 Catheter ablation, which is centered on electrical isolation of triggering foci within the pulmonary veins (PVI) through circumferential lesions around PV ostia, has been shown to result in sustained improvements in quality of life, decreased hospitalizations and, potentially, improved survival.2-4 PVI can be accomplished by percutaneous catheter-based thermo-coagulation (burning) with radiofrequency (RF) energy delivery or alternatively by thermo-cooling (freezing) with a cryoballoon catheter.5 Cryothermal ablation with a cryoballoon catheter offers an efficacious means to achieve PVI that is safer than the established technique. Although cryoballoon ablation has been used in clinical practice for sometime, the optimal duration of cryoballoon ablation has not been determined. Moreover, the biophysics of cryo-lesion formation suggests that repeated short freezes ("freeze-thaw-freeze" cycles) may be more efficacious in achieving deep homogenous lesion when compared to prolonged freezing durations. This grant proposal is to verify if repeated short freezing cycles are more efficacious (i.e., fewer recurrence of AF), and safer, than the established standard of long, single freeze cycles.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 1, 2013
Enrollment StartSep 1, 2014
Primary CompletionDec 1, 2018
Study CompletionMar 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 12.9 years ago

Interventions

Pulmonary Vein Isolationprocedure