Therapeutic Outcomes Using Contact Force Handling During Atrial Fibrillation Ablation

NCT ID: NCT01851525

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2017-02-15

Brief Summary

Catheter ablation has emerged as an effective therapy for atrial fibrillation (AF). However, achievement of complete& durable isolation of the pulmonary veins (PVs) is challenging, primary limited both by operator experience and also the limits of currently available ablation technology. Direct contact force sensing (CFS) is a novel technology that may help to ensure adequate lesion delivery. CFS may also help to improve the safety profile of catheter ablation. The purpose of this study is to compare two strategies of wide antral PV isolation plus linear ablation for persistent AF:

1. guided by contact force sensing (CFS) OR

2. blinded to contact force sensing (CFS) - i.e. standard approach

Conditions

Persistent Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Contact Force Sensing (CFS) Blinded

Contact Force Sensing (CFS) Blinded: Operator will be blinded to data provided by the integrated force sensor in the ablation catheter (ThermoCoolSmartTouch ablation catheter)

Group Type: ACTIVE_COMPARATOR

ThermoCoolSmartTouch ablation catheter, Biosense Webster

Intervention Type: DEVICE

Contact Force Sensing (CFS) Guided

Contact Force Sensing (CFS) Guided: Operator will be guided by integrated force sensor in the ablation catheter (ThermoCoolSmartTouch ablation catheter)

Group Type: ACTIVE_COMPARATOR

ThermoCoolSmartTouch ablation catheter, Biosense Webster

Intervention Type: DEVICE

Interventions

ThermoCoolSmartTouch ablation catheter, Biosense Webster

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age > 18 years.
• Patients undergoing first-time catheter ablation for AF.
• Persistent AF defined as episodes greater than 7 days duration.
• Symptomatic AF defined as patients who have been aware of their AF anytime within the last 5 years prior to enrolment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of the above.
• At least one episode of AF must have been documented by ECG, Holter, loop recorder, telemetry, implanted device, or transtelephonic monitoring within 24 months of enrolment.
• Willing and able to provide informed consent.

Exclusion Criteria

• Paroxysmal AF.
• AF secondary to a reversible cause.
• Patients with contraindications to systemic anticoagulation with heparin, coumadin, or a direct thrombin inhibitor.
• Patients who have previously undergone AF ablation.
• Patients with left atrial size >55 mm (echocardiography, parasternal long axis view).
• Patients who are or may potentially be pregnant.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Applied Health Research Centre

OTHER

Sponsor Role: collaborator

Southlake Regional Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Atul Verma

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Atul Verma, MD

Role: PRINCIPAL_INVESTIGATOR

Southlake Regional Health Centre

Locations

Vancouver Island Cardiac Arrhythmia Clinic

Victoria, British Columbia, Canada

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Laval University Cardiac and Pulmonary Institute

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

01

Identifier Type: -

Identifier Source: org_study_id