Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC)

Not Applicable

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT01520532
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-25
• Study First Submitted QC: 2012-01-27
• Study First Posted: 2012-01-30
• Study Start: 2012-03
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Results First Submitted: 2012-12-10
• Results First Submitted QC: 2013-02-12
• Results First Posted: 2013-03-14
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI.	Within 1-3 days post ablation	An acute embolic lesion is defined as a focal hyper-intense area detected on the diffusion-weighted (DW) sequence, corresponding to a hyper-intense signal intensity in the fluid-attenuated inversion recovery (FLAIR) sequence, and also confirmed by apparent diffusion coefficient (ADC) mapping to rule out a shine-through artifact.

Secondary Outcome Measures

Name	Time	Method
Acute Safety Events	30 days	Assess the number of procedure or device-related serious adverse events when applying best practices with PVAC.
Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject.	Day 1 (End of Procedure)	The number of subjects with pulmonary vein isolation (PVI) at the end of ablation procedure. This will characterize if use of best practices during PVAC ablation negatively affects acute efficacy.

Trial Locations

Locations (7)

AZ Middelheim; 🇧🇪 Antwerpen, Belgium

Imelda Ziekenhuis; 🇧🇪 Bonheiden, Belgium

Southlake Regional Health Center; 🇨🇦 Newmarket, Ontario, Canada

Herz- und Gefäß-Klinik; 🇩🇪 Bad Neustadt/Saale, Germany

Praxisklinik - Herz- und Gefässe; 🇩🇪 Dresden, Germany

Clinica Pineta Grande; 🇮🇹 Castel Volturno, Italy

AZ Sint Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands