An MRI-validated study of the superiority of a contact feedback catheter in AF ablation - pre study

Phase 4

Completed

• Conditions: Atrial Fibrillation; 10007521

• Registration Number: NL-OMON40242
• Lead Sponsor: Medisch Spectrum Twente

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

• Paroxysmal atrial fibrillation for which >= 1 electrical and/or chemical cardioversions and persistent atrial fibrillation, eligible for pulmonary vein isolation according to current international guidelines.
• Age < 70 years.
• Willing and able to sign informed consent.
• Willing to and capable of following the requested study procedures.

Exclusion Criteria

• Age < 18 years.
• Pregnancy
• Life or follow-up expectancy < 12 months.
• Previous pumonary vein isolation in history.
• Contrast allergy.
• Creatin clearance level lower than 60.
• MRI scanning not possible (e.g. because of metal implant or claustrophobia).
• Abnormal left atrium anatomy. This will lead to exclusion after inclusion but before andomisation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To perform a pre-study to assess the feasibility of DE-MRI to assess lesion<br /><br>size, transmurality and completeness of pulmonary vein isolation. The study<br /><br>will be performed to determine if and how DE-MRI can be used in a subsequent<br /><br>multicentre study (MERCI-AF study). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To collect data on the use of contact-feedback which could be included in the<br /><br>MERCI-AF study.</p><br>