Serial Hybrid Atrial Fibrillation Ablation

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2017-12-31

Brief Summary

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Treatment of (long-standing) persistent atrial fibrillation (AF) remains cumbersome and the surgical (epicardial) approach seems to be the most effective. Still, however a significant amount of failures exist which is mostly due to incompleteness of the surgical ablation lines. Checking, and if necessary additional ablation, of these lines afterwards endocardially by the cardiologist (the so-called serial hybrid approach) could overcome this problem.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Epicardial (surgical) ablation

Epicardial Pulmonary vein isolation

Group Type ACTIVE_COMPARATOR

Epicardial (surgical) ablation

Intervention Type PROCEDURE

* Pulmonary vein isolation with bipolar clamps and bipolar box lesion
* Epicardial atrial appendage closure

Hybrid

Epicardial (surgical) ablation \& Endocardial assessment

Group Type EXPERIMENTAL

Hybrid

Intervention Type PROCEDURE

Epicardial (surgical) ablation

* Pulmonary vein isolation with bipolar clamps and bipolar box lesion
* Epicardial atrial appendage closure

Endocardial assessment after 6-8 weeks, checking for isolation and if necessary touch up by RF ablation

Interventions

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Epicardial (surgical) ablation

* Pulmonary vein isolation with bipolar clamps and bipolar box lesion
* Epicardial atrial appendage closure

Intervention Type PROCEDURE

Hybrid

Epicardial (surgical) ablation

* Pulmonary vein isolation with bipolar clamps and bipolar box lesion
* Epicardial atrial appendage closure

Endocardial assessment after 6-8 weeks, checking for isolation and if necessary touch up by RF ablation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients are screened and accepted for pulmonary vein isolation according to the current guidelines
* long standing persistent or persistent AF as defined in the guidelines
* left atrial size needs to be more than \>46 mm on long axis or \>35 cc/m2
* CHADSVASC score should be more than 0 as an indicator of a substantial substrate for atrial fibrillation.

Exclusion Criteria

* Significant coronary artery disease has to be excluded as a trigger for AF by means of cardiac CT, if necessary a coronary angiogram will be performed.
* Previous PVI ablation (epicardial or endocardial) or cardiac surgery.
* Significant valvular disease present on echo.
* Concomitant cardiac surgery needed.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No