Contact Force Sensing Use in Atrial Fibrillation Ablation

Atrial Fibrillation Clinical Trial

Official title:

The Role of Contact Force Sensing in Electrical Pulmonary Vein Isolation When Conducting Atrial Fibrillation Ablation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01630330
• Other study ID #: 2012CI002B
• Status: Recruiting
• Phase: N/A
• First received: June 26, 2012
• Last updated: June 26, 2012
• Start date: May 2012
• Est. completion date: December 2013

Study information

• Verified date: June 2012
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: Shouvik Haldar, MRCP
• Phone: 0207 351 8121
• Email: s.haldar[@]rbht.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with symptomatic AF

Exclusion Criteria:

• Recent CVA

• Contraindication to warfarin therapy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Ablation
Atrial Fibrillation Ablation with SmartTouch catheter
• Ablation
Atrial Fibrillation Ablation with SmartTouch catheter

Locations

Country	Name	City	State
United Kingdom	Royal Brompton & Harefield Hospital NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Acute Pulmonary Vein Reconnection		1 hour post procedure	No