Back to resultsSerial Hybrid Atrial Fibrillation Ablation (SHAFT)
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Epicardial (surgical) ablation
Hybrid
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial, fibrillation, pvi, vats, ablation, hybrid
Eligibility 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.
Sites / Locations
- Medisch Spectrum TwenteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Epicardial (surgical) ablation
Hybrid
Arm Description
Epicardial Pulmonary vein isolation
Epicardial (surgical) ablation & Endocardial assessment
Outcomes
Primary Outcome Measures
Atrial fibrillation Freedom
left sided atrial flutter and left atrial tachycardia
Secondary Outcome Measures
re-isolation
number of pulmonary veins needing re-isolation by the EP
Percentage of cross-over
Percentage of cross-over from the surgical arm alone to surgery and serial hybrid ablation.
Complications
Number of complications and thrombo-embolic events in both groups
Atrial fibrillation Burden
Burden of AF in both groups if AF is still present.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01582828
Brief Title
Serial Hybrid Atrial Fibrillation Ablation
Acronym
SHAFT
Official Title
Serial Hybrid Atrial Fibrillation Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medisch Spectrum Twente
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial, fibrillation, pvi, vats, ablation, hybrid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Epicardial (surgical) ablation
Arm Type
Active Comparator
Arm Description
Epicardial Pulmonary vein isolation
Arm Title
Hybrid
Arm Type
Experimental
Arm Description
Epicardial (surgical) ablation & Endocardial assessment
Intervention Type
Procedure
Intervention Name(s)
Epicardial (surgical) ablation
Intervention Description
Pulmonary vein isolation with bipolar clamps and bipolar box lesion
Epicardial atrial appendage closure
Intervention Type
Procedure
Intervention Name(s)
Hybrid
Intervention Description
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
Primary Outcome Measure Information:
Title
Atrial fibrillation Freedom
Description
left sided atrial flutter and left atrial tachycardia
Time Frame
12 months
Secondary Outcome Measure Information:
Title
re-isolation
Description
number of pulmonary veins needing re-isolation by the EP
Time Frame
8-10 weeks
Title
Percentage of cross-over
Description
Percentage of cross-over from the surgical arm alone to surgery and serial hybrid ablation.
Time Frame
1 year
Title
Complications
Description
Number of complications and thrombo-embolic events in both groups
Time Frame
1 year
Title
Atrial fibrillation Burden
Description
Burden of AF in both groups if AF is still present.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jurren van Opstal, MD PhD
Phone
+31534872110
Email
cardiologen@mst.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Harald Verheij
Phone
+31534872108
Email
h.verheij@mst.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jurren van Opstal, MD PhD
Organizational Affiliation
Medisch Spectrum Twente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medisch Spectrum Twente
City
Enschede
State/Province
OV
ZIP/Postal Code
7500AB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jurren van Opstal, MD PhD
Phone
+31534872110
Email
cardiologen@mst.nl
First Name & Middle Initial & Last Name & Degree
Harald Verheij
Phone
+31534872108
Email
h.verheij@mst.nl
First Name & Middle Initial & Last Name & Degree
Bob Oude Velthuis, MD MSc
12. IPD Sharing Statement
Learn more about this trial
Serial Hybrid Atrial Fibrillation Ablation
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