heart rhythm disorders - atrial fibrillation
Conditions
Interventions
The following information is required to be collected at the ablation procedure
or within specified timeframe prior to the ablation procedure:
• MRI scan (FLAIR and diffusion weighted) within 48 hour
if between 1.8 and 2.0,
subject required to be treated with heparin or low molecular weight heparin
within 4 hours post-procedure until INR is >= 2)
Procedure preparation
• Inject heparin bolus imm
Sponsors
Medtronic B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Report rate of ACE (number of subjects presenting with post-procedural asymptomatic cerebral embolic lesions as determined by MRI) | — |
Secondary
| Measure | Time frame |
|---|---|
| The Secondary study objectives are: - Characterize Acute procedural success --> Acute procedural success will be defined as: only PVAC GOLD catheters(s) used to achieve pulmonary vein isolation AND all accessible pulmonary veins were isolated (entrance block) AND sinus rhythm is restored at the end of the ablation procedure (with or without cardioversion) - Report procedure and device related serious adverse event rate --> Summarize all procedure and/or device related serious adverse events using PVAC GOLD within 30 days of an ablation procedure. The ancillary study objectives are: - Report PVAC GOLD procedure times Report procedure times including total time, total fluoroscopy time, time spent in Electrophysiology (EP) lab/Operating Room (OR), LA dwell time, total energy delivery time. - Report procedure details • Number of energy applications per vein • Energy modes used • Electrodes turned off/on - Report cumulative RF energy delivered - Summarize results of MMSE - Summarize adverse events | — |
Countries
Netherlands
Outcome results
None listed