Back to resultsA Pilot Study of a Contact Force Catheter for Pulmonary Vein Antrum Isolation (CFC-PVAI)
Primary Purpose
Atrial Fibrillation, Burden of Atrial Fibrillation
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Contact Force during ablation
Standard ablation procedure
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring contact force catheter, loop recorder
Eligibility Criteria
Inclusion Criteria:
- Patients <75 years of age with atrial fibrillation who have had at least two episodes of symptomatic paroxysmal or short-lasting persistent atrial fibrillation in the foregoing 12 months undergoing the first pulmonary vein antrum isolation can be included.
- Patients having also persistent episodes of atrial fibrillation of shorter duration (the longest atrial fibrillation episode 3 months) on top of paroxysmal episodes will be included
Exclusion Criteria:
- Contraindication to anticoagulation treatment with vitamin K antagonists Amiodarone therapy Expected surgery for structural heart disease within the follow-up period Significant mitral valve disease NYHA III-IV Left ventricular ejection fraction < 35% Left atrial diameter > 5 cm Secondary atrial fibrillation (e.g. post-surgery, infections, hyperthyroidism) Age < 18 years
Sites / Locations
- Aarhus University Hospital - Skejby
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Contact Force arm
Standard
Arm Description
the real-time contact force will be known to the operator
Standard ablation arm
Outcomes
Primary Outcome Measures
Reduction in atrial fibrillation burden (after 3 months blanking period) in comparison with the period prior to ablation in the absence of antiarrhythmic drugs
The atrial fibrillation burden defined as the percentage of time spent i atrial fibrillation monitored by an implantable cardiac loop recorder.
Secondary Outcome Measures
Contact Force distribution during procedure (g/cm2) Post ablation A-fib burden(% of time in atrial fibrillation) Complications (number) Time spent on RFA of each pulmonary vein (min.) Reconnected pulmonary veins during adenosine/isoprenaline
Full Information
NCT ID
NCT01538277
First Posted
February 20, 2012
Last Updated
October 27, 2016
Sponsor
University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT01538277
Brief Title
A Pilot Study of a Contact Force Catheter for Pulmonary Vein Antrum Isolation
Acronym
CFC-PVAI
Official Title
A Pilot Study of a Contact Force Catheter for Pulmonary Vein Antrum Isolation (CFC-PVAI)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The knowledge of the real-time contact force leads to a greater reduction in atrial fibrillation burden after pulmonary vein antrum isolation.
Detailed Description
A randomized controlled study comparing pulmonary vein antrum isolation with and without the knowledge of the real-time contact force. In both groups, a catheter, which is able to measure contact force (SmartTouch, ThermoCool catheter, Biosense Webster) will be used. In the control group, the operator will be blinded to the measured contact-force. In all patients, the ablation will be guided by a circumferential mapping catheter (Lasso, Biosense Webster), CARTO 3 mapping system and ablation of adenosine-induced reconnection will be performed in all patients. Follow-up will be performed by continuous monitoring using an implantable loop recorder (Reveal XT, Medtronic Inc, Minneapolis, Minn)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Burden of Atrial Fibrillation
Keywords
contact force catheter, loop recorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Contact Force arm
Arm Type
Experimental
Arm Description
the real-time contact force will be known to the operator
Arm Title
Standard
Arm Type
Active Comparator
Arm Description
Standard ablation arm
Intervention Type
Procedure
Intervention Name(s)
Contact Force during ablation
Intervention Description
Radio Frequency Ablation procedure with real-time contact force information known to the operator
Intervention Type
Other
Intervention Name(s)
Standard ablation procedure
Intervention Description
Standard ablation procedure
Primary Outcome Measure Information:
Title
Reduction in atrial fibrillation burden (after 3 months blanking period) in comparison with the period prior to ablation in the absence of antiarrhythmic drugs
Description
The atrial fibrillation burden defined as the percentage of time spent i atrial fibrillation monitored by an implantable cardiac loop recorder.
Time Frame
12 month follow after the RFA treatment
Secondary Outcome Measure Information:
Title
Contact Force distribution during procedure (g/cm2) Post ablation A-fib burden(% of time in atrial fibrillation) Complications (number) Time spent on RFA of each pulmonary vein (min.) Reconnected pulmonary veins during adenosine/isoprenaline
Time Frame
12 month follow up after the RFA treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients <75 years of age with atrial fibrillation who have had at least two episodes of symptomatic paroxysmal or short-lasting persistent atrial fibrillation in the foregoing 12 months undergoing the first pulmonary vein antrum isolation can be included.
Patients having also persistent episodes of atrial fibrillation of shorter duration (the longest atrial fibrillation episode 3 months) on top of paroxysmal episodes will be included
Exclusion Criteria:
Contraindication to anticoagulation treatment with vitamin K antagonists Amiodarone therapy Expected surgery for structural heart disease within the follow-up period Significant mitral valve disease NYHA III-IV Left ventricular ejection fraction < 35% Left atrial diameter > 5 cm Secondary atrial fibrillation (e.g. post-surgery, infections, hyperthyroidism) Age < 18 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik k Jensen, phD, Dr Med
Organizational Affiliation
University of Aarhus
Official's Role
Study Director
Facility Information:
Facility Name
Aarhus University Hospital - Skejby
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of a Contact Force Catheter for Pulmonary Vein Antrum Isolation
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