The OneFreeze Study
| Status: | Recruiting |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 4/2/2016 |
| Start Date: | October 2014 |
| End Date: | September 2016 |
| Contact: | Gevorg Stepanyan, MS, CCRP |
| Email: | GStepanyan@medicine.ucsf.edu |
| Phone: | 415-502-0937 |
THE ONE FREEZE STUDY: A PROSPECTIVE MULTI-CENTER RANDOMIZED CONTROLLED TRIAL TO ASSESS THE SAFETY AND EFFICACY OF ONE VS. TWO CRYOABLATIONS PER PULMONARY VEIN FOR THE TREATMENT OF ATRIAL FIBRILLATION
It is an unproven assumption that at least 2 cryoablations is necessary in each pulmonary
vein for successful ablation of atrial fibrillation. The investigators hypothesize that a
single cryoablation in each pulmonary vein that achieves isolation may leads to equivalent
efficacy with decreased risk. The One Freeze Study evaluates this hypothesis.
This study compares one 3-minute cryoablation per pulmonary vein versus two 3-minute
cryoablations per pulmonary vein during atrial fibrillation ablation procedures.
vein for successful ablation of atrial fibrillation. The investigators hypothesize that a
single cryoablation in each pulmonary vein that achieves isolation may leads to equivalent
efficacy with decreased risk. The One Freeze Study evaluates this hypothesis.
This study compares one 3-minute cryoablation per pulmonary vein versus two 3-minute
cryoablations per pulmonary vein during atrial fibrillation ablation procedures.
Inclusion Criteria:
- Paroxysmal atrial fibrillation*AF patients scheduled for AF PVI ablation with
cryoballoon
- Age >18 years
- Life expectancy ≥ 1 year
- Willing and able to return to and comply with scheduled follow-up visits
- Willing and able to provide written informed consent
Exclusion Criteria:
- History of > 5 electric cardioversions
- History of previous pulmonary vein isolation ablation for atrial fibrillation
- History of MAZE procedure
- Left ventricular Ejection Fraction <25 %
- Mechanical mitral valve
- Single pulmonary vein > 30mm in diameter.
- Inability to consent
- Stroke/transient ischemic attack within the past 6 months
- Creatinine > 2.0 mg/dL
- Pregnancy or desire to get pregnant within the next 12 months.
- Current enrollment in an investigation or study of a cardiovascular device or
investigational drug that would interfere with this study
- Mental impairment or other conditions, which may not allow the participant to
understand the nature, significance and scope of the study
- Any other condition or circumstance that in the judgment of the clinicianPrincipal
Investigator that makes the participant unsuitable for the study
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