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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Annetine Gelijns, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00903370
First received: May 14, 2009
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

The purpose of the research is to determine whether treating atrial fibrillation with surgical ablation during scheduled mitral valve surgery is better than mitral valve surgery by itself without the surgical ablation. Surgical ablation of atrial fibrillation is a technique used by surgeons to deaden atrial heart tissue and block electrical signals that may be causing your heart to beat irregularly. There are no new procedures being tested in this study; both mitral valve surgery and surgical ablation are used regularly in patients who have mitral valve problems and atrial fibrillation, although no surgical ablation devices have been approved by the Food and Drug Administration for the treatment of atrial fibrillation. What is not known with certainty, is whether patients with atrial fibrillation who are having planned mitral valve surgery would do better if they also had surgical ablation rather than medication alone to treat their atrial fibrillation.


Condition Intervention Phase
Atrial Fibrillation
Mitral Valve Insufficiency
Mitral Valve Stenosis
Device: MVS + ablation
Procedure: MVS alone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Surgical Ablation Versus No Surgical Ablation for Patients With Persistent or Longstanding Persistent Atrial Fibrillation (AF) Undergoing Mitral Valve Surgery

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Freedom from atrial fibrillation [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 260
Study Start Date: January 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MVS alone
Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.
Procedure: 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.
Other Names:
  • Mitral Valve Repair
  • Mitral Valve Replacement
Experimental: 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.
Device: 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 is noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture is noted, additional ablations on the atrial cuff will be performed until isolation is confirmed. This will be repeated on the left pulmonary veins.

Other Names:
  • Mitral Valve Repair
  • Mitral Valve Replacement
  • Surgical Ablation

Detailed Description:

The purpose of this study is to determine whether the addition of surgical ablation to planned mitral valve surgery for patients with persistent or longstanding persistent AF (within 6 months prior to randomization) reduces the incidence of postoperative heart arrhythmia compared to mitral valve repair with medication therapy alone. This is a randomized, multi-center trial which will enroll 260 subjects who will be randomized in a 1:1 fashion to: (a) mitral valve surgery plus surgical ablation or (b) mitral valve surgery without ablation (control group). All patients will undergo ligation or excision of the left atrial appendage. Patients assigned to the ablation group will be further randomized (1:1) to one of two lesion sets: (1) pulmonary vein isolation only or (2) biatrial Maze lesions. The target population for this trial consists of adult patients with mitral valve disease requiring surgical intervention and persistent or longstanding persistent atrial fibrillation. All patients who meet the eligibility criteria may be included in the study regardless of gender, race or ethnicity. The primary efficacy endpoint is freedom from AF, which will be measured by 3-day continuous monitoring at 6 months and 12 months post-ablation. The primary safety endpoint is a composite of death, stroke, serious cardiac events (heart failure, myocardial infarction), cardiac re-hospitalizations, transient ischemic attack, pulmonary embolism, peripheral embolism, excessive bleeding, deep sternal wound infection/mediastinitis, damage to specialized conduction system requiring permanent pacemaker, damage to peripheral structures, such as the esophagus, within 30 days post-procedure or hospital discharge (whichever is later).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to sign Informed Consent and Release of Medical Information forms
  • Age ≥ 18 years
  • Clinical indications for mitral valve surgery for the following:

    1. Organic mitral valve disease; or
    2. Functional non-ischemic mitral regurgitation; or
    3. Ischemic mitral regurgitation with evidence of concomitant structural mitral valve disease

Note: May include need for surgical management of functional tricuspid regurgitation or patent foramen ovale. May also include concomitant CABG, aortic arch or aortic valve procedure. Surgical intervention may be performed via sternotomy or minimally invasive procedure.

  • a) Persistent AF within 6 months prior to randomization, defined as non self-terminating AF lasting greater than 7 days but no more than one year, or lasting less than 7 days but necessitating pharmacologic or electrical cardioversion.

    • Duration of AF must be documented by medical history and
    • Presence of AF must be documented by a direct electrocardiographic assessment within 6 months prior to randomization.
  • b) Longstanding persistent AF is defined as continuous AF of greater than one year duration.

    • Duration of AF must be documented by medical history and
    • Presence of AF must be documented by a direct electrocardiographic assessment upon arrival in the OR.
  • Able to use heart rhythm monitor

Exclusion Criteria:

  • 1. AF without indication for mitral valve surgery 2. AF is paroxysmal 3. Evidence of left atrial thrombus by intra-operative TEE 4. Evidence of active infection 5. Mental impairment or other conditions that may not allow subject to understand the nature, significance, and scope of study 6. Surgical management of hypertrophic obstructive cardiomyopathy 7. Previous catheter ablation for AF 8. Life expectancy of less than one year 9. Absolute contraindications for anticoagulation therapy 10. Enrollment in concomitant drug or device trials 11. Uncontrolled hypo- or hyperthyroidism 12. FEV1 < 30% of predicted value and/or need for home oxygen therapy 13. Women who are pregnant as evidenced by positive pregnancy test 14. Women of childbearing age who do not agree to be on adequate birth control throughout the period of the trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903370

  Show 21 Study Locations
Sponsors and Collaborators
Annetine Gelijns
Canadian Institutes of Health Research (CIHR)
Investigators
Study Chair: Timothy Gardner, MD Christiana Care Health Services
Study Chair: Patrick O'Gara, MD Brigham and Women's Hospital
Principal Investigator: Annetine C. Gelijns, Ph.D. Mount Sinai School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Annetine Gelijns, Professor of Health Policy, Chair Department of Health Evidence & Policy, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00903370     History of Changes
Other Study ID Numbers: GCO 08-1078 0004, U01HL088942, U01HL088942-03, 656
Study First Received: May 14, 2009
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration
Canada: Canadian Institutes of Health Research

Keywords provided by Mount Sinai School of Medicine:
Mitral Valve Regurgitation
Mitral Valve Surgery
Mitral Valve Disease
Ablation, Catheter
Catheter Ablation, Radiofrequency

Additional relevant MeSH terms:
Atrial Fibrillation
Mitral Valve Insufficiency
Mitral Valve Stenosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Valve Diseases

ClinicalTrials.gov processed this record on July 22, 2014