Working… Menu
Trial record 44 of 11710 for:    Contact

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01538277
Recruitment Status : Completed
First Posted : February 24, 2012
Last Update Posted : October 28, 2016
Information provided by (Responsible Party):
University of Aarhus

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

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

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)

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of a Contact Force Catheter for Pulmonary Vein Antrum Isolation (CFC-PVAI)
Study Start Date : February 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]
    The atrial fibrillation burden defined as the percentage of time spent i atrial fibrillation monitored by an implantable cardiac loop recorder.

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01538277

Layout table for location information
Aarhus University Hospital - Skejby
Aarhus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Layout table for investigator information
Study Director: Henrik k Jensen, phD, Dr Med University of Aarhus

Layout table for additonal information
Responsible Party: University of Aarhus Identifier: NCT01538277     History of Changes
Other Study ID Numbers: CFC-PVAI
First Posted: February 24, 2012    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: March 2012
Keywords provided by University of Aarhus:
contact force catheter
loop recorder
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes