NCT01851525

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. 1.guided by contact force sensing (CFS) OR
  2. 2.blinded to contact force sensing (CFS) - i.e. standard approach

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 10, 2013

Completed
22 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2017

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

3.7 years

First QC Date

May 5, 2013

Last Update Submit

April 24, 2017

Conditions

Persistent Atrial Fibrillation

Keywords

Atrial fibrillationAblation

Outcome Measures

Primary Outcomes (1)

  • Total cumulative radio frequency (RF) delivery time

    Total cumulative RF delivery time for all ablation procedures performed during the study period (12 mo)

    12 months

Secondary Outcomes (15)

  • Freedom from AF or atrial arrhythmia >30 sec

    12 months

  • Ability to achieve PV isolation with a single ring of lesions around each PV

    6 hours

  • Ability to achieve linear ablation with complete conduction block on the first attempt

    6 hours

  • Number & location of conduction gaps after initial circumferential ablation lines

    6 hours

  • Number & location of conduction gaps after initial linear ablation

    6 hours

  • +10 more secondary outcomes

Study Arms (2)

Contact Force Sensing (CFS) Blinded

ACTIVE COMPARATOR

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

Device: ThermoCoolSmartTouch ablation catheter, Biosense Webster

Contact Force Sensing (CFS) Guided

ACTIVE COMPARATOR

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

Device: ThermoCoolSmartTouch ablation catheter, Biosense Webster

Interventions

ThermoCoolSmartTouch ablation catheter, Biosense WebsterDEVICE
Contact Force Sensing (CFS) BlindedContact Force Sensing (CFS) Guided

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Vancouver Island Cardiac Arrhythmia Clinic

Victoria, British Columbia, V8R 4R2, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Laval University Cardiac and Pulmonary Institute

Québec, Quebec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Atul Verma, MD

    Southlake Regional Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 5, 2013

First Posted

May 10, 2013

Study Start

June 1, 2013

Primary Completion

February 15, 2017

Study Completion

February 15, 2017

Last Updated

April 25, 2017

Record last verified: 2017-04

Locations

CA(4)