Back to resultsContact Force Sensing Use in Atrial Fibrillation Ablation
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ablation
Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Patients with symptomatic AF
Exclusion Criteria:
- Recent CVA
- Contraindication to warfarin therapy
Sites / Locations
- Royal Brompton & Harefield Hospital NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Contact Force Known
Contact Force Not Known
Arm Description
Ablation with contact force data known
Contact Force data unavailable during ablation
Outcomes
Primary Outcome Measures
Rate of Acute Pulmonary Vein Reconnection
Secondary Outcome Measures
Full Information
NCT ID
NCT01630330
First Posted
June 26, 2012
Last Updated
June 26, 2012
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT01630330
Brief Title
Contact Force Sensing Use in Atrial Fibrillation Ablation
Official Title
The Role of Contact Force Sensing in Electrical Pulmonary Vein Isolation When Conducting Atrial Fibrillation Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Brompton & Harefield NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Contact Force Known
Arm Type
Active Comparator
Arm Description
Ablation with contact force data known
Arm Title
Contact Force Not Known
Arm Type
Experimental
Arm Description
Contact Force data unavailable during ablation
Intervention Type
Procedure
Intervention Name(s)
Ablation
Intervention Description
Atrial Fibrillation Ablation with SmartTouch catheter
Intervention Type
Procedure
Intervention Name(s)
Ablation
Intervention Description
Atrial Fibrillation Ablation with SmartTouch catheter
Primary Outcome Measure Information:
Title
Rate of Acute Pulmonary Vein Reconnection
Time Frame
1 hour post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with symptomatic AF
Exclusion Criteria:
Recent CVA
Contraindication to warfarin therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shouvik Haldar, MRCP
Phone
0207 351 8121
Ext
8742
Email
s.haldar@rbht.nhs.uk
Facility Information:
Facility Name
Royal Brompton & Harefield Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom Wong, MD, FRCP
12. IPD Sharing Statement
Learn more about this trial
Contact Force Sensing Use in Atrial Fibrillation Ablation
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