Contact Force Sensing Use in Atrial Fibrillation Ablation

Not Applicable

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Ablation

• Registration Number: NCT01630330
• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust

Brief Summary

There are multiple important factors which need to be monitored when conducting ablation for atrial fibrillation. The contact between the catheter tip and the inside of the heart wall is now measurable and may improve the effectiveness of catheter ablation for atrial fibrillation patients.

Detailed Description

This study compares patients who have this procedure where this contact information is known (unblinded) versus those where the contact information is not known (blinded). The outcome is the rate of acute reconnection at 1 hour after achieving pulmonary vein isolation.

Study Timeline

• Study Start: 2012-05
• Status Verified: 2012-06
• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-06-26
• Last Update Submitted: 2012-06-26
• Study First Posted: 2012-06-28
• Last Update Posted: 2012-06-28
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with symptomatic AF

Exclusion Criteria

• Recent CVA
• Contraindication to warfarin therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contact Force Known	Ablation	Ablation with contact force data known
Contact Force Not Known	Ablation	Contact Force data unavailable during ablation

Primary Outcome Measures

Name	Time	Method
Rate of Acute Pulmonary Vein Reconnection	1 hour post procedure

Trial Locations

Locations (1)

Royal Brompton & Harefield Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom