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Serial Hybrid Atrial Fibrillation Ablation (SHAFT)

This study is not yet open for participant recruitment.
Verified April 2012 by Medisch Spectrum Twente
Sponsor:
Information provided by (Responsible Party):
B. Oude Velthuis, Medisch Spectrum Twente
ClinicalTrials.gov Identifier:
NCT01582828
First received: April 20, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Atrial Fibrillation
 Procedure: Epicardial (surgical) ablation
Procedure: Hybrid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Serial Hybrid Atrial Fibrillation Ablation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medisch Spectrum Twente:

Primary Outcome Measures:
  • Atrial fibrillation Freedom [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    left sided atrial flutter and left atrial tachycardia


Secondary Outcome Measures:
  • re-isolation [ Time Frame: 8-10 weeks ] [ Designated as safety issue: No ]
    number of pulmonary veins needing re-isolation by the EP

  • Percentage of cross-over [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Percentage of cross-over from the surgical arm alone to surgery and serial hybrid ablation.

  • Complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Number of complications and thrombo-embolic events in both groups

  • Atrial fibrillation Burden [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Burden of AF in both groups if AF is still present.


Estimated Enrollment: 162
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Epicardial (surgical) ablation
Epicardial Pulmonary vein isolation
 Procedure: Epicardial (surgical) ablation
  • Pulmonary vein isolation with bipolar clamps and bipolar box lesion
  • Epicardial atrial appendage closure
Experimental: Hybrid
Epicardial (surgical) ablation & Endocardial assessment
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582828

Contacts
Contact: Jurren van Opstal, MD PhD +31534872110 cardiologen@mst.nl
Contact: Harald Verheij +31534872108 h.verheij@mst.nl

Locations
Netherlands
Medisch Spectrum Twente Not yet recruiting
Enschede, OV, Netherlands, 7500AB
Contact: Jurren van Opstal, MD PhD     +31534872110     cardiologen@mst.nl    
Contact: Harald Verheij     +31534872108     h.verheij@mst.nl    
Sub-Investigator: Bob Oude Velthuis, MD MSc            
Sponsors and Collaborators
Medisch Spectrum Twente
Investigators
Principal Investigator: Jurren van Opstal, MD PhD Medisch Spectrum Twente
  More Information

No publications provided

Responsible Party: B. Oude Velthuis, Research fellow electrophysiology, Medisch Spectrum Twente
ClinicalTrials.gov Identifier: NCT01582828     History of Changes
Other Study ID Numbers: SHAFT-01
Study First Received: April 20, 2012
Last Updated: April 20, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Medisch Spectrum Twente:
atrial
fibrillation
pvi
 vats
ablation
hybrid

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013