N/A
Completed N=60
Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC)
Source: ClinicalTrials.gov NCT01520532 ↗Enrolled (actual)
60
Serious AEs
1.7%
Results posted
Mar 2013
Primary outcomePrimary: New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI. — 1 participants
Summary
The purpose of the study is to determine the rate of diffusion weighted (DW)-MRI cerebral lesions following a Pulmonary Vein Ablation Catheter (PVAC) ablation procedure performed using best practices, including optimized procedural techniques and anti-coagulation therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI. |
1 | — |
| SECONDARY Acute Safety Events |
1 | — |
| SECONDARY Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject. |
60 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is at least 18 years old
- Subject has been diagnosed with atrial fibrillation (AF)
- Subject is indicated for a pulmonary vein ablation using PVAC
- Subject (or subject's legally authorized representative) is able and and willing to give informed consent.
Exclusion Criteria
- Subject has permanent AF
- Subject has a left atrial thrombus detected on TEE
- Subject has had a prior left atrial ablation
- Subject has a intracardiac thrombus
- Subject is contraindicated for Warfarin (Coumadin)
- 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 presence of any pulmonary vein stents
- Subject has presence of any pre-existing pulmonary vein stenosis
- Subject has had a cerebral ischemic event (strokes or transient ischemic attacks [TIA]) which occurred during the 6 month interval preceding the Consent Date
- Subject is a woman known to be pregnant
- Subject is unwilling or unable to comply fully with study procedures and follow-up
Data sourced from ClinicalTrials.gov (NCT01520532). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.