Contact Force Sensing Use in Atrial Fibrillation Ablation

Royal Brompton & Harefield NHS Foundation Trust

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Procedure: Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT01630330

2012CI002B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with symptomatic AF

Exclusion criteria

• Recent CVA
• Contraindication to warfarin therapy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Contact Force Known

Active Comparator group

Description:

Ablation with contact force data known

Treatment:

Procedure: Ablation

Procedure: Ablation

Contact Force Not Known

Experimental group

Description:

Contact Force data unavailable during ablation

Treatment:

Procedure: Ablation

Procedure: Ablation