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Clinical Trials/NCT01582828
NCT01582828
Withdrawn
Not Applicable

Serial Hybrid Atrial Fibrillation Ablation

Medisch Spectrum Twente1 site in 1 country162 target enrollmentStarted: August 2012Last updated:
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ConditionsAtrial Fibrillation

Overview

Phase
Not Applicable
Status
Withdrawn
Enrollment
162
Locations
1
Primary Endpoint
Atrial fibrillation Freedom
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Atrial fibrillation Freedom

Time Frame: 12 months

left sided atrial flutter and left atrial tachycardia

Secondary Outcomes

  • re-isolation(8-10 weeks)
  • Percentage of cross-over(1 year)
  • Complications(1 year)
  • Atrial fibrillation Burden(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

B. Oude Velthuis

Research fellow electrophysiology

Medisch Spectrum Twente

Study Sites (1)

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