Trial Outcomes & Findings for Mitral Implantation of TRAnscatheter vaLves (NCT NCT02370511)
NCT ID: NCT02370511
Last Updated: 2023-10-10
Results Overview
Number of subject to achieve technical success (at exit from cath lab) is defined as: * Successful vascular delivery and retrieval of transcatheter valve delivery system * Deployment of single valve * Correct position of transcatheter valve * Adequate performance of prosthesis (MVA \> 1.5 cm2) without residual MR grade ≥2 (+) * No need for additional surgery or re-intervention * Patient leaves cath lab alive
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
91 participants
Primary outcome timeframe
30 days
Results posted on
2023-10-10
Participant Flow
Participant milestones
| Measure |
Native Mitral Valve With Severe MAC
Patients with symptomatic severe calcific native mitral valve disease with severe mitral annular calcification who have extremely high surgical risk for standard surgical mitral valve replacement, will undergo transcatheter mitral valve replacement.
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
Valve-in-Ring
Patients with symptomatic failing surgical rings resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (valve-in-ring).
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
Valve-in-Valve
Patients with symptomatic failing surgical bioprostheses resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (Valve-in-valve).
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
30
|
|
Overall Study
COMPLETED
|
19
|
19
|
29
|
|
Overall Study
NOT COMPLETED
|
12
|
11
|
1
|
Reasons for withdrawal
| Measure |
Native Mitral Valve With Severe MAC
Patients with symptomatic severe calcific native mitral valve disease with severe mitral annular calcification who have extremely high surgical risk for standard surgical mitral valve replacement, will undergo transcatheter mitral valve replacement.
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
Valve-in-Ring
Patients with symptomatic failing surgical rings resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (valve-in-ring).
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
Valve-in-Valve
Patients with symptomatic failing surgical bioprostheses resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (Valve-in-valve).
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
|---|---|---|---|
|
Overall Study
Death
|
10
|
7
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
0
|
Baseline Characteristics
Mitral Implantation of TRAnscatheter vaLves
Baseline characteristics by cohort
| Measure |
Native Mitral Valve With Severe MAC
n=31 Participants
Patients with symptomatic severe calcific native mitral valve disease with severe mitral annular calcification who have extremely high surgical risk for standard surgical mitral valve replacement, will undergo transcatheter mitral valve replacement.
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
Valve-in-Ring
n=30 Participants
Patients with symptomatic failing surgical rings resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (valve-in-ring).
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
Valve-in-Valve
n=30 Participants
Patients with symptomatic failing surgical bioprostheses resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (Valve-in-valve).
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
74.5 years
n=5 Participants
|
71.5 years
n=7 Participants
|
77.5 years
n=5 Participants
|
75.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
30 participants
n=7 Participants
|
30 participants
n=5 Participants
|
91 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 daysNumber of subject to achieve technical success (at exit from cath lab) is defined as: * Successful vascular delivery and retrieval of transcatheter valve delivery system * Deployment of single valve * Correct position of transcatheter valve * Adequate performance of prosthesis (MVA \> 1.5 cm2) without residual MR grade ≥2 (+) * No need for additional surgery or re-intervention * Patient leaves cath lab alive
Outcome measures
| Measure |
Native Mitral Valve With Severe MAC
n=31 Participants
Patients with symptomatic severe calcific native mitral valve disease with severe mitral annular calcification who have extremely high surgical risk for standard surgical mitral valve replacement, will undergo transcatheter mitral valve replacement.
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
Valve-in-Ring
n=30 Participants
Patients with symptomatic failing surgical rings resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (valve-in-ring).
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
Valve-in-Valve
n=30 Participants
Patients with symptomatic failing surgical bioprostheses resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (Valve-in-valve).
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
|---|---|---|---|
|
Technical Success at Exit From the Cath Lab.
|
23 Participants
|
20 Participants
|
30 Participants
|
PRIMARY outcome
Timeframe: 30 days and 1 yearPopulation: For MAC arm at 30 days 5 patients died and one withdrew consent and at 1 yr 5 additional patients died, 1 additional withdrew consent and 1 additional did not complete 1 yr follow up. For Valve-in-Ring arm at 30 days 2 patients died and at 1 yr 5 additional patients died, 1 patient lost to follow up and 3 did not complete 1 yr follow up. For Valve-in-Valve arm 1 patient died. Data was not collected or analyzed for these patients.
Number of subjects to have absence of MR grade 2 (+) or greater assessed with echocardiography. MR severity grading system ranging from Grade 1=mild; Grade 4=severe.
Outcome measures
| Measure |
Native Mitral Valve With Severe MAC
n=25 Participants
Patients with symptomatic severe calcific native mitral valve disease with severe mitral annular calcification who have extremely high surgical risk for standard surgical mitral valve replacement, will undergo transcatheter mitral valve replacement.
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
Valve-in-Ring
n=28 Participants
Patients with symptomatic failing surgical rings resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (valve-in-ring).
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
Valve-in-Valve
n=29 Participants
Patients with symptomatic failing surgical bioprostheses resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (Valve-in-valve).
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
|---|---|---|---|
|
Absence of MR Grade 2 (+) or Greater
30 days
|
23 Participants
|
28 Participants
|
29 Participants
|
|
Absence of MR Grade 2 (+) or Greater
1 year
|
18 Participants
|
19 Participants
|
29 Participants
|
PRIMARY outcome
Timeframe: 30 days and 1 yearPopulation: For MAC arm at 30 days 5 patients died and one withdrew consent and at 1 yr 5 additional patients died, 1 additional withdrew consent and 1 additional did not complete 1 yr follow up. For Valve-in-Ring arm at 30 days 2 patients died and at 1 yr 5 additional patients died, 1 patient lost to follow up and 3 did not complete 1 yr follow up. For Valve-in-Valve arm 1 patient died. Data was not collected or analyzed for these patients.
MVG assessed by echocardiography measured in mmHg
Outcome measures
| Measure |
Native Mitral Valve With Severe MAC
n=25 Participants
Patients with symptomatic severe calcific native mitral valve disease with severe mitral annular calcification who have extremely high surgical risk for standard surgical mitral valve replacement, will undergo transcatheter mitral valve replacement.
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
Valve-in-Ring
n=28 Participants
Patients with symptomatic failing surgical rings resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (valve-in-ring).
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
Valve-in-Valve
n=29 Participants
Patients with symptomatic failing surgical bioprostheses resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (Valve-in-valve).
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
|---|---|---|---|
|
Mitral Valve Gradient (MVG)
30 days
|
6.0 mmHg
Interval 5.2 to 7.8
|
7.6 mmHg
Interval 5.9 to 9.1
|
6.0 mmHg
Interval 4.7 to 7.3
|
|
Mitral Valve Gradient (MVG)
1 year
|
6.1 mmHg
Interval 5.6 to 7.1
|
6.0 mmHg
Interval 4.7 to 7.3
|
6.6 mmHg
Interval 5.5 to 8.9
|
SECONDARY outcome
Timeframe: 30 daysPopulation: For MAC arm 1 withdrew consent data was not collected or analyzed.
Number of subject to have procedural success as defined as no device/procedure related SAE's including: death, stroke, MI or coronary ischemia requiring PCI or CABG, stage 2 or 3 AKI including dialysis, life threatening bleeding, major vascular or access complications (arterial, venous, or TA - any event requiring additional unplanned surgical or transcatheter intervention), pericardial effusion or tamponade requiring drainage, severe hypotension, heart failure or respiratory failure requiring intravenous pressors or invasive or mechanical treatments such as ultrafiltration or hemodynamic assist devices including intra-aortic balloon pump or left ventricular assist device, or prolonged intubation for ≥48 hrs, or any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention.
Outcome measures
| Measure |
Native Mitral Valve With Severe MAC
n=30 Participants
Patients with symptomatic severe calcific native mitral valve disease with severe mitral annular calcification who have extremely high surgical risk for standard surgical mitral valve replacement, will undergo transcatheter mitral valve replacement.
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
Valve-in-Ring
n=30 Participants
Patients with symptomatic failing surgical rings resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (valve-in-ring).
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
Valve-in-Valve
n=30 Participants
Patients with symptomatic failing surgical bioprostheses resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (Valve-in-valve).
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
|---|---|---|---|
|
Procedural Success
|
16 Participants
|
22 Participants
|
28 Participants
|
Adverse Events
Native Mitral Valve With Severe MAC
Serious events: 18 serious events
Other events: 17 other events
Deaths: 10 deaths
Valve-in-Ring
Serious events: 13 serious events
Other events: 12 other events
Deaths: 7 deaths
Valve-in-Valve
Serious events: 8 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Native Mitral Valve With Severe MAC
n=31 participants at risk
Patients with symptomatic severe calcific native mitral valve disease with severe mitral annular calcification who have extremely high surgical risk for standard surgical mitral valve replacement, will undergo transcatheter mitral valve replacement.
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
Valve-in-Ring
n=30 participants at risk
Patients with symptomatic failing surgical rings resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (valve-in-ring).
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
Valve-in-Valve
n=30 participants at risk
Patients with symptomatic failing surgical bioprostheses resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (Valve-in-valve).
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
|---|---|---|---|
|
Nervous system disorders
Stroke
|
6.5%
2/31 • Number of events 2 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
6.7%
2/30 • Number of events 2 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
16.1%
5/31 • Number of events 5 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
13.3%
4/30 • Number of events 4 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
0.00%
0/30 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
|
Vascular disorders
Vascular complications
|
3.2%
1/31 • Number of events 1 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
6.7%
2/30 • Number of events 2 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
3.3%
1/30 • Number of events 2 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
|
Cardiac disorders
Atrial fibrillation
|
16.1%
5/31 • Number of events 5 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
0.00%
0/30 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
|
Blood and lymphatic system disorders
Hemolytic anemia
|
16.1%
5/31 • Number of events 5 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
10.0%
3/30 • Number of events 3 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
0.00%
0/30 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
|
Vascular disorders
Valve thrombosis
|
3.2%
1/31 • Number of events 1 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
0.00%
0/30 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
0.00%
0/30 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
|
Cardiac disorders
Mitral valve reintervention after index procedure
|
12.9%
4/31 • Number of events 4 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
10.0%
3/30 • Number of events 4 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
0.00%
0/30 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
|
Cardiac disorders
New permanent pacemaker requirement
|
16.1%
5/31 • Number of events 5 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
0.00%
0/30 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
|
Cardiac disorders
New rehospitalization for heart failure
|
35.5%
11/31 • Number of events 15 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
16.7%
5/30 • Number of events 6 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
16.7%
5/30 • Number of events 7 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
Other adverse events
| Measure |
Native Mitral Valve With Severe MAC
n=31 participants at risk
Patients with symptomatic severe calcific native mitral valve disease with severe mitral annular calcification who have extremely high surgical risk for standard surgical mitral valve replacement, will undergo transcatheter mitral valve replacement.
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
Valve-in-Ring
n=30 participants at risk
Patients with symptomatic failing surgical rings resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (valve-in-ring).
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
Valve-in-Valve
n=30 participants at risk
Patients with symptomatic failing surgical bioprostheses resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (Valve-in-valve).
Transcatheter Mitral Valve Replacement: Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Blood transfusion
|
54.8%
17/31 • Number of events 17 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
40.0%
12/30 • Number of events 12 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
20.0%
6/30 • Number of events 6 • Adverse events were collected all subjects from baseline to end of study, approximately one year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place