Trial Outcomes & Findings for Surgical Ablation Versus No Surgical Ablation for Patients With Atrial Fibrillation Undergoing Mitral Valve Surgery (NCT NCT00903370)
NCT ID: NCT00903370
Last Updated: 2017-02-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
260 participants
Primary outcome timeframe
Measured at Month 12
Results posted on
2017-02-06
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
127
|
133
|
|
Overall Study
COMPLETED
|
99
|
109
|
|
Overall Study
NOT COMPLETED
|
28
|
24
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Death
|
13
|
10
|
|
Overall Study
Withdrawal by Subject
|
9
|
6
|
|
Overall Study
Lost to Follow-up
|
6
|
8
|
Baseline Characteristics
Surgical Ablation Versus No Surgical Ablation for Patients With Atrial Fibrillation Undergoing Mitral Valve Surgery
Baseline characteristics by cohort
| Measure |
MVS Alone
n=127 Participants
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
n=133 Participants
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
n=260 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.4 years
STANDARD_DEVIATION 10 • n=5 Participants
|
69.7 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
69.6 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Gender
Female
|
63 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Gender
Male
|
64 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
119 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
112 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
21 participants
n=5 Participants
|
22 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
106 participants
n=5 Participants
|
111 participants
n=7 Participants
|
217 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 12Population: Since the primary analysis is an intent-to-treat, outcomes were imputed for patients with missing data.
Outcome measures
| Measure |
MVS Alone
n=127 Participants
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
n=133 Participants
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.
|
|---|---|---|
|
Freedom From Atrial Fibrillation
|
31.1 percentage of patients
Interval 22.6 to 40.1
|
61.8 percentage of patients
Interval 51.4 to 72.2
|
SECONDARY outcome
Timeframe: Less than 30 days post-procedure or hospital dischargeOutcome measures
| Measure |
MVS Alone
n=127 Participants
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
n=133 Participants
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.
|
|---|---|---|
|
Composite of Death, Stroke, Serious Adverse Events (Cardiac and Non-cardiac), and Cardiac Re-hospitalizations Less Than 30 Days Post-procedure or Hospital Discharge
|
22.8 percentage of patients
Interval 15.5 to 30.1
|
31.6 percentage of patients
Interval 23.7 to 39.5
|
Adverse Events
MVS Alone
Serious events: 69 serious events
Other events: 36 other events
Deaths: 0 deaths
MVS + Ablation
Serious events: 77 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MVS Alone
n=127 participants at risk
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
n=133 participants at risk
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.
|
|---|---|---|
|
General disorders
Bleeding
|
4.7%
6/127 • Number of events 6
|
5.3%
7/133 • Number of events 7
|
|
Cardiac disorders
Arrhythmias-Sustained ventricular arrhythmia
|
4.7%
6/127 • Number of events 6
|
3.0%
4/133 • Number of events 4
|
|
Cardiac disorders
Arrhythmias-Sustained supraventricular arrhythmia
|
12.6%
16/127 • Number of events 21
|
14.3%
19/133 • Number of events 30
|
|
Cardiac disorders
Cardiac conduction abnormalities requiring PPM
|
7.1%
9/127 • Number of events 9
|
18.8%
25/133 • Number of events 25
|
|
Cardiac disorders
Pericardial Fluid Collection
|
3.9%
5/127 • Number of events 5
|
3.0%
4/133 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.1%
4/127 • Number of events 4
|
8.3%
11/133 • Number of events 11
|
|
Cardiac disorders
Non-infectious Pericarditis
|
0.00%
0/127
|
0.75%
1/133 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.6%
2/127 • Number of events 2
|
0.75%
1/133 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic Dysfunction
|
2.4%
3/127 • Number of events 3
|
2.3%
3/133 • Number of events 3
|
|
Infections and infestations
Major Infection - Localized - Pneumonia
|
7.9%
10/127 • Number of events 11
|
2.3%
3/133 • Number of events 3
|
|
Infections and infestations
Major Infection - Localized - Other
|
5.5%
7/127 • Number of events 7
|
6.0%
8/133 • Number of events 10
|
|
Infections and infestations
Major Infection - Endocarditis
|
0.79%
1/127 • Number of events 1
|
0.75%
1/133 • Number of events 1
|
|
Infections and infestations
Major Infection - Sepsis
|
3.1%
4/127 • Number of events 4
|
6.0%
8/133 • Number of events 8
|
|
Cardiac disorders
Heart Failure
|
8.7%
11/127 • Number of events 13
|
10.5%
14/133 • Number of events 19
|
|
Cardiac disorders
Myocardial Infarction
|
1.6%
2/127 • Number of events 2
|
1.5%
2/133 • Number of events 2
|
|
Nervous system disorders
Neurological Dysfunction - CVA-Ischemic
|
2.4%
3/127 • Number of events 3
|
2.3%
3/133 • Number of events 4
|
|
Nervous system disorders
Neurological Dysfunction - CVA-Hemorrhagic
|
0.00%
0/127
|
0.75%
1/133 • Number of events 1
|
|
Nervous system disorders
Neurological Dysfunction - Toxic Metabolic Encephalopathy
|
0.00%
0/127
|
0.75%
1/133 • Number of events 1
|
|
Nervous system disorders
Neurological Dysfunction - Other (not stroke, TIA, Toxic Metabolic Encephalopathy)
|
0.79%
1/127 • Number of events 1
|
2.3%
3/133 • Number of events 3
|
|
Renal and urinary disorders
Renal Dysfunction (no dialysis)
|
3.1%
4/127 • Number of events 4
|
0.75%
1/133 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure (dialysis)
|
1.6%
2/127 • Number of events 2
|
3.0%
4/133 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
11.0%
14/127 • Number of events 16
|
4.5%
6/133 • Number of events 6
|
|
Cardiac disorders
Right Heart Failure
|
0.00%
0/127
|
0.75%
1/133 • Number of events 1
|
|
Vascular disorders
Venous Thromboembolism Event
|
2.4%
3/127 • Number of events 4
|
2.3%
3/133 • Number of events 3
|
Other adverse events
| Measure |
MVS Alone
n=127 participants at risk
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
n=133 participants at risk
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.
|
|---|---|---|
|
General disorders
Bleeding
|
0.00%
0/127
|
1.5%
2/133 • Number of events 2
|
|
Cardiac disorders
Arrhythmias-Sustained supraventricular arrhythmia
|
11.8%
15/127 • Number of events 19
|
8.3%
11/133 • Number of events 12
|
|
Cardiac disorders
Cardiac conduction abnormalities requiring PPM
|
2.4%
3/127 • Number of events 3
|
0.75%
1/133 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
7.1%
9/127 • Number of events 9
|
6.8%
9/133 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/127
|
3.0%
4/133 • Number of events 4
|
|
Injury, poisoning and procedural complications
Major Infection - Localized - Other
|
3.9%
5/127 • Number of events 5
|
5.3%
7/133 • Number of events 7
|
|
Nervous system disorders
Neurological Dysfunction - Toxic Metabolic Encephalopathy
|
0.00%
0/127
|
1.5%
2/133 • Number of events 2
|
|
Nervous system disorders
Neurological Dysfunction - Other (not stroke, TIA, Toxic Metabolic Encephalopathy)
|
1.6%
2/127 • Number of events 2
|
1.5%
2/133 • Number of events 2
|
|
Renal and urinary disorders
Renal Dysfunction (no dialysis)
|
1.6%
2/127 • Number of events 2
|
2.3%
3/133 • Number of events 3
|
|
Vascular disorders
Venous Thromboembolism Event
|
1.6%
2/127 • Number of events 2
|
0.75%
1/133 • Number of events 1
|
Additional Information
Annetine C. Gelijns, PhD
Icahn School of Medicine at Mount Sinai
Phone: 212-659-9568
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place