We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    00903370
Previous Study | Return to List | Next Study

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00903370
First Posted: May 18, 2009
Last Update Posted: February 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Results First Submitted: September 30, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Atrial Fibrillation
Mitral Valve Insufficiency
Mitral Valve Stenosis
Interventions: Procedure: MVS
Device: Ablation

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
  Hide Baseline Characteristics

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.
No text entered.

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]
Count of Participants
     
Female      63  49.6%      57  42.9%      120  46.2% 
Male      64  50.4%      76  57.1%      140  53.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      8   6.3%      10   7.5%      18   6.9% 
Not Hispanic or Latino      119  93.7%      123  92.5%      242  93.1% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      3   2.4%      2   1.5%      5   1.9% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      12   9.4%      15  11.3%      27  10.4% 
White      112  88.2%      116  87.2%      228  87.7% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
Canada   21   22   43 
United States   106   111   217 


  Outcome Measures
  Show All Outcome Measures

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: Less than 30 days post-procedure or hospital discharge ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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 ( U.S. NIH Grant/Contract )
U01HL088942-03 ( U.S. NIH Grant/Contract )
656 ( Other Identifier: Cardiothoracic Surgical Trials Network )
First Submitted: May 14, 2009
First Posted: May 18, 2009
Results First Submitted: September 30, 2016
Results First Posted: November 22, 2016
Last Update Posted: February 6, 2017