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Surgical Ablation Versus No Surgical Ablation for Patients With Atrial Fibrillation Undergoing Mitral Valve Surgery

This study has been completed.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Neurological Disorders and Stroke (NINDS)
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Annetine Gelijns, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT00903370
First received: May 14, 2009
Last updated: September 30, 2016
Last verified: September 2016
Results First Received: September 30, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Atrial Fibrillation
Mitral Valve Insufficiency
Mitral Valve Stenosis
Interventions: Device: MVS + ablation
Procedure: MVS alone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
MVS Alone

Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.

MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed.

MVS + Ablation

Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.

MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.

For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed.


Participant Flow:   Overall Study
    MVS Alone   MVS + Ablation
STARTED   127   133 
COMPLETED   99   109 
NOT COMPLETED   28   24 
Death                13                10 
Withdrawal by Subject                9                6 
Lost to Follow-up                6                8 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
MVS Alone

Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.

MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed.

MVS + Ablation

Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.

MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.

For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed.

Total Total of all reporting groups

Baseline Measures
   MVS Alone   MVS + Ablation   Total 
Overall Participants Analyzed 
[Units: Participants]
 127   133   260 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.4  (10)   69.7  (10.4)   69.6  (10.2) 
Gender 
[Units: Participants]
     
Female   63   57   120 
Male   64   76   140 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   8   10   18 
Not Hispanic or Latino   119   123   242 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   3   2   5 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   12   15   27 
White   112   116   228 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
Canada   21   22   43 
United States   106   111   217 


  Outcome Measures
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1.  Primary:   Freedom From Atrial Fibrillation   [ Time Frame: Measured at Month 12 ]

2.  Secondary:   Composite of Death, Stroke, Serious Adverse Events (Cardiac and Non-cardiac), and Cardiac Re-hospitalizations Less Than 30 Days Post-procedure or Hospital Discharge   [ Time Frame: Measured at Month 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Annetine C. Gelijns, PhD
Organization: Icahn School of Medicine at Mount Sinai
phone: 212-659-9568
e-mail: annetine.gelijns@mssm.edu


Publications of Results:

Responsible Party: Annetine Gelijns, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00903370     History of Changes
Other Study ID Numbers: GCO 08-1078-0004
U01HL088942 ( US NIH Grant/Contract Award Number )
U01HL088942-03 ( US NIH Grant/Contract Award Number )
656 ( Other Identifier: Cardiothoracic Surgical Trials Network )
Study First Received: May 14, 2009
Results First Received: September 30, 2016
Last Updated: September 30, 2016
Health Authority: United States: Food and Drug Administration
Canada: Canadian Institutes of Health Research