Serial Hybrid Atrial Fibrillation Ablation

Not Applicable

Withdrawn

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Hybrid; Procedure: Epicardial (surgical) ablation

• Registration Number: NCT01582828
• Lead Sponsor: Medisch Spectrum Twente

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-20
• Study First Submitted QC: 2012-04-20
• Study First Posted: 2012-04-23
• Study Start: 2012-08
• Primary Completion: 2016-12
• Study Completion: 2017-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 162

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hybrid	Hybrid	Epicardial (surgical) ablation \& Endocardial assessment
Epicardial (surgical) ablation	Epicardial (surgical) ablation	Epicardial Pulmonary vein isolation

Primary Outcome Measures

Name	Time	Method
Atrial fibrillation Freedom	12 months	left sided atrial flutter and left atrial tachycardia

Secondary Outcome Measures

Name	Time	Method
re-isolation	8-10 weeks	number of pulmonary veins needing re-isolation by the EP
Percentage of cross-over	1 year	Percentage of cross-over from the surgical arm alone to surgery and serial hybrid ablation.
Complications	1 year	Number of complications and thrombo-embolic events in both groups
Atrial fibrillation Burden	1 year	Burden of AF in both groups if AF is still present.

Trial Locations

Locations (1)

Medisch Spectrum Twente; 🇳🇱 Enschede, OV, Netherlands