Serial Hybrid Atrial Fibrillation Ablation

Atrial Fibrillation Clinical Trial

— SHAFT  

Official title:

Serial Hybrid Atrial Fibrillation Ablation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01582828
• Other study ID #: SHAFT-01
• Status: Recruiting
• Phase: N/A
• First received: April 20, 2012
• Last updated: July 6, 2016
• Start date: August 2012
• Est. completion date: December 2017

Study information

• Verified date: July 2016
• Source: Medisch Spectrum Twente
• Contact: Jurren van Opstal, MD PhD
• Phone: +31534872110
• Email: cardiologen[@]mst.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Epicardial (surgical) ablation
Pulmonary vein isolation with bipolar clamps and bipolar box lesion Epicardial atrial appendage closure
• 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

Locations

Country	Name	City	State
Netherlands	Medisch Spectrum Twente	Enschede	OV

Sponsors (1)

Lead Sponsor	Collaborator
Medisch Spectrum Twente

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation Freedom	left sided atrial flutter and left atrial tachycardia	12 months	No
Secondary	re-isolation	number of pulmonary veins needing re-isolation by the EP	8-10 weeks	No
Secondary	Percentage of cross-over	Percentage of cross-over from the surgical arm alone to surgery and serial hybrid ablation.	1 year	No
Secondary	Complications	Number of complications and thrombo-embolic events in both groups	1 year	Yes
Secondary	Atrial fibrillation Burden	Burden of AF in both groups if AF is still present.	1 year	No