Serial Hybrid Atrial Fibrillation Ablation (SHAFT)

Medisch Spectrum Twente

Status: Withdrawn

Conditions: Atrial Fibrillation

Treatments: Procedure: Epicardial (surgical) ablation; Procedure: Hybrid

Study type: Interventional

Funder types: Other

Identifiers

NCT01582828

SHAFT-01

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Epicardial (surgical) ablation

Active Comparator group

Description:

Epicardial Pulmonary vein isolation

Treatment:

Procedure: Epicardial (surgical) ablation

Hybrid

Experimental group

Description:

Epicardial (surgical) ablation \& Endocardial assessment

Treatment:

Procedure: Hybrid