Phased RF Evaluation of ACute Pulmonary Vein ISolation In ParOxysmal AF with New GENius UI and PVAC® Gold

Completed

Conditions: heart rhythm disorders - atrial fibrillation
10007521

Registration Number: NL-OMON39982

Lead Sponsor: Medtronic B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Subject has Symptomatic paroxysmal AF defined as :
- Episodes of AF
- >=2 recurrent AF episodes that self-terminate, lasting no more than 7 continuous days
or
- episodes of AF <= 48 hours duration terminated with electrical or pharmacologic cardioversion
counts as a PAF episode
- Electrocardiographically documentation of one or more events with PAF (ECG, event recordings,
pacemaker strips or monitor rhythm strips) within the past year
- AF symptoms defined as the manifestation of any of the following: palpitations, fatigue,
exertional dyspnea, effort intolerance;Subject is on a Vitamin K antagonist (i.e. Warfarin/Coumadin)
Subject between 18 and 70 years old
Subject is indicated for a pulmonary vein ablation
Subject is able and willing to give informed consent
Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study.

Exclusion Criteria

Subject has persistent or permanent AF
Subject has had a prior left atrial ablation
Subject has a intracardiac thrombus
Subject is contraindicated for Vitamin K antagonist (i.e. Warfarin/Coumadin)
Subject is prescribed to direct thrombin or factor inhibitors (i.e. Dabigatran, Rivaroxaban)
Subject prescribed any investigational drug that may confound the study results
Subject has a cardiac valve prosthesis
Subject has a significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)
Subject has pulmonary vein stents
Subject has any pre-existing pulmonary vein stenosis
Subject has had a cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date
Subject is a woman known to be pregnant
Participation in any other cardiovascular clinical study
Subject contraindicated for MRI
Subject has active sepsis
Subject has blood clotting abnormalities (genetic)
Subject has left atrial myxoma
Subject has a venous filtering device (Greenfield filter)
Subject has had an invasive cardiac procedure in the past 90 days

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Report rate of ACE (number of subjects presenting with post-procedural<br /><br>asymptomatic cerebral embolic lesions as determined by MRI)</p><br>

Secondary Outcome Measures