A Pilot Study of a Contact Force Catheter for Pulmonary Vein Antrum Isolation

Phase 2

Completed

• Conditions: Burden of Atrial Fibrillation; Atrial Fibrillation
• Interventions: Procedure: Contact Force during ablation; Other: Standard ablation procedure

• Registration Number: NCT01538277
• Lead Sponsor: 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.

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)

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-20
• Study First Submitted QC: 2012-02-20
• Study First Posted: 2012-02-24
• Status Verified: 2012-03
• Primary Completion: 2014-09
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contact Force arm	Contact Force during ablation	the real-time contact force will be known to the operator
Standard	Standard ablation procedure	Standard ablation arm

Primary Outcome Measures

Name	Time	Method
Reduction in atrial fibrillation burden (after 3 months blanking period) in comparison with the period prior to ablation in the absence of antiarrhythmic drugs	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

Name	Time	Method
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	12 month follow up after the RFA treatment

Trial Locations

Locations (1)

Aarhus University Hospital - Skejby; 🇩🇰 Aarhus, Denmark