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

NCT ID: NCT01538277

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-10-31

Brief Summary

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

Detailed Description

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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)

Conditions

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Atrial Fibrillation Burden of Atrial Fibrillation

Keywords

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contact force catheter loop recorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Contact Force arm

the real-time contact force will be known to the operator

Group Type EXPERIMENTAL

Contact Force during ablation

Intervention Type PROCEDURE

Radio Frequency Ablation procedure with real-time contact force information known to the operator

Standard

Standard ablation arm

Group Type ACTIVE_COMPARATOR

Standard ablation procedure

Intervention Type OTHER

Standard ablation procedure

Interventions

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Contact Force during ablation

Radio Frequency Ablation procedure with real-time contact force information known to the operator

Intervention Type PROCEDURE

Standard ablation procedure

Standard ablation procedure

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Henrik k Jensen, phD, Dr Med

Role: STUDY_DIRECTOR

University of Aarhus

Locations

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Aarhus University Hospital - Skejby

Aarhus, Denmark, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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CFC-PVAI

Identifier Type: -

Identifier Source: org_study_id