Serial Hybrid Atrial Fibrillation Ablation (SHAFT)

November 20, 2024 updated by: B. Oude Velthuis, Medisch Spectrum Twente
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • OV
      • Enschede, OV, Netherlands, 7500AB
        • Medisch Spectrum Twente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial fibrillation Freedom
Time Frame: 12 months
left sided atrial flutter and left atrial tachycardia
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medisch Spectrum Twente

Investigators

  • Principal Investigator: Jurren van Opstal, MD PhD, Medisch Spectrum Twente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Estimated)

December 1, 2016

Study Completion (Estimated)

December 1, 2017

Study Registration Dates

First Submitted

April 20, 2012

First Submitted That Met QC Criteria

April 20, 2012

First Posted (Estimated)

April 23, 2012

Study Record Updates

Last Update Posted (Actual)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHAFT-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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