A Pilot Study of a Contact Force Catheter for Pulmonary Vein Antrum Isolation (CFC-PVAI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01538277
First received: February 20, 2012
Last updated: September 11, 2014
Last verified: March 2012
  Purpose

The knowledge of the real-time contact force leads to a greater reduction in atrial fibrillation burden after pulmonary vein antrum isolation.


Condition Intervention Phase
Atrial Fibrillation
Burden of Atrial Fibrillation
Procedure: Contact Force during ablation
Other: Standard ablation procedure
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of a Contact Force Catheter for Pulmonary Vein Antrum Isolation (CFC-PVAI)

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

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 [ Time Frame: 12 month follow after the RFA treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 month follow up after the RFA treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2012
Estimated Study Completion Date: March 2016
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Contact Force arm
the real-time contact force will be known to the operator
Procedure: Contact Force during ablation
Radio Frequency Ablation procedure with real-time contact force information known to the operator
Active Comparator: Standard
Standard ablation arm
Other: Standard ablation procedure
Standard ablation procedure

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01538277

Locations
Denmark
Aarhus University Hospital - Skejby
Aarhus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Investigators
Study Director: Henrik k Jensen, phD, Dr Med University of Aarhus
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01538277     History of Changes
Other Study ID Numbers: CFC-PVAI
Study First Received: February 20, 2012
Last Updated: September 11, 2014
Health Authority: Denmark: National Board of Health

Keywords provided by University of Aarhus:
contact force catheter
loop recorder

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

ClinicalTrials.gov processed this record on October 23, 2014