Contact Force Sensing Use in Atrial Fibrillation Ablation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Royal Brompton & Harefield NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01630330
First received: June 26, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Procedure: Ablation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Role of Contact Force Sensing in Electrical Pulmonary Vein Isolation When Conducting Atrial Fibrillation Ablation

Resource links provided by NLM:


Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Primary Outcome Measures:
  • Rate of Acute Pulmonary Vein Reconnection [ Time Frame: 1 hour post procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Contact Force Known
Ablation with contact force data known
Procedure: Ablation
Atrial Fibrillation Ablation with SmartTouch catheter
Experimental: Contact Force Not Known
Contact Force data unavailable during ablation
Procedure: Ablation
Atrial Fibrillation Ablation with SmartTouch catheter

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with symptomatic AF

Exclusion Criteria:

  • Recent CVA
  • Contraindication to warfarin therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630330

Contacts
Contact: Shouvik Haldar, MRCP 0207 351 8121 ext 8742 s.haldar@rbht.nhs.uk

Locations
United Kingdom
Royal Brompton & Harefield Hospital NHS Foundation Trust Recruiting
London, United Kingdom, SW3 6NP
Principal Investigator: Tom Wong, MD, FRCP         
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01630330     History of Changes
Other Study ID Numbers: 2012CI002B
Study First Received: June 26, 2012
Last Updated: June 26, 2012
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014