Brief Summary
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.
Brief Title
Surgical Ablation Versus No Surgical Ablation for Patients With Atrial Fibrillation Undergoing Mitral Valve Surgery
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).
Categories
Completion Date
Completion Date Type
Actual
Conditions
Atrial Fibrillation
Mitral Valve Insufficiency
Mitral Valve Stenosis
Eligibility 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.
* 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.
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Mitral Valve Regurgitation
Mitral Valve Surgery
Mitral Valve Disease
Ablation, Catheter
Catheter Ablation, Radiofrequency
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT00903370
Org Class
Other
Org Full Name
Icahn School of Medicine at Mount Sinai
Org Study Id
GCO 08-1078-0004
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Surgical Ablation Versus No Surgical Ablation for Patients With Persistent or Longstanding Persistent Atrial Fibrillation (AF) Undergoing Mitral Valve Surgery
Primary Outcomes
Outcome Measure
Freedom From Atrial Fibrillation
Outcome Time Frame
Measured at Month 12
Secondary Ids
Secondary Id
U01HL088942
Secondary Id
U01HL088942-03
Secondary Id
656
Secondary Outcomes
Outcome Time Frame
Less than 30 days post-procedure or hospital discharge
Outcome Measure
Composite of Death, Stroke, Serious Adverse Events (Cardiac and Non-cardiac), and Cardiac Re-hospitalizations Less Than 30 Days Post-procedure or Hospital Discharge
See Also Links
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Robert Michler
Investigator Email
RMICHLER@MONTEFIORE.ORG
Investigator Phone
rmichler