Therapeutic Outcomes Using Contact Force Handling During Atrial Fibrillation Ablation

NCT01851525 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-04-25

No results posted yet for this study

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

Interventions

DEVICE

ThermoCoolSmartTouch ablation catheter, Biosense Webster

Sponsors & Collaborators

  • Applied Health Research Centre

    collaborator OTHER
  • Southlake Regional Health Centre

    lead OTHER

Principal Investigators

  • Atul Verma, MD · Southlake Regional Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2017-02-15
Completion
2017-02-15

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01851525 on ClinicalTrials.gov