Trial Outcomes & Findings for MitraClip Russia Trial (NCT NCT04350372)
NCT ID: NCT04350372
Last Updated: 2022-06-14
Results Overview
Successful implantation of the MitraClip NT device resulting in a decrease in the MR severity grade as assessed from the discharge echocardiogram (10-day echocardiogram will be used if discharge is unavailable or uninterpretable). Subjects who die or undergo mitral valve surgery before discharge will be considered a failure for the procedure
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
30-day
Results posted on
2022-06-14
Participant Flow
Participant milestones
| Measure |
MitraClip
Subject will receive MitraClip procedure with MitraClip NT System
MitraClip Procedure: MitraClip procedure with MitraClip NT System
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
MitraClip
Subject will receive MitraClip procedure with MitraClip NT System
MitraClip Procedure: MitraClip procedure with MitraClip NT System
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MitraClip
n=16 Participants
Subject will receive MitraClip procedure with MitraClip NT System
MitraClip Procedure: MitraClip procedure with MitraClip NT System
|
|---|---|
|
Age, Continuous
|
70.1 Years
STANDARD_DEVIATION 10.8 • n=16 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=16 Participants
|
|
Region of Enrollment
Russia
|
16 participants
n=16 Participants
|
|
Height
|
168.7 cm
STANDARD_DEVIATION 11.9 • n=16 Participants
|
|
Weight
|
81.3 Kg
STANDARD_DEVIATION 21.1 • n=16 Participants
|
|
Patients with Society of Thoracic Surgeons (STS) Mitral Valve Replacement Score >= 8%
|
7 Participants
n=16 Participants
|
|
Mitral Regurgitation
3+ (Moderately Severe)
|
7 Participants
n=16 Participants
|
|
Mitral Regurgitation
4+ (Severe)
|
9 Participants
n=16 Participants
|
|
Body Mass Index
|
28.19 kg/m^2
STANDARD_DEVIATION 4.28 • n=16 Participants
|
|
Society of Thoracic Surgeons (STS) Mitral Valve
|
6.33 Percentage of Risk
STANDARD_DEVIATION 3.94 • n=16 Participants
|
|
BNP
|
532.71 pg/mL
STANDARD_DEVIATION 562.18 • n=10 Participants • All the available data have been reported.
|
|
NT proBNP
|
2426.87 pg/mL
STANDARD_DEVIATION 2706.58 • n=15 Participants • All the available data have been reported.
|
|
Serum Creatinine
|
1.34 mg/dL
STANDARD_DEVIATION 0.40 • n=16 Participants
|
|
Effective Regurgitant Orifice Area (EROA)
|
0.39 cm^2
STANDARD_DEVIATION 0.14 • n=16 Participants
|
|
Regurgitant Volume (RV)
|
53.6 mL/beat
STANDARD_DEVIATION 9.0 • n=16 Participants
|
|
Regurgitant Fraction (RF)
|
58.9 %
STANDARD_DEVIATION 16.4 • n=15 Participants • All the available data have been reported.
|
|
Mitral Valve Area (MVA)
|
5.53 cm^2
STANDARD_DEVIATION 0.57 • n=16 Participants
|
|
Left Ventricular Ejection Fraction (LVEF)
|
46.1 %
STANDARD_DEVIATION 12.0 • n=16 Participants
|
|
Left Ventricular End Systolic Dimension (LVESD)
|
4.47 cm
STANDARD_DEVIATION 0.91 • n=16 Participants
|
|
Ventricular End Diastolic Dimension (LVEDD)
|
6.05 cm
STANDARD_DEVIATION 0.77 • n=16 Participants
|
|
Left Ventricular End Systolic Volume (LVESV)
|
93.8 mL
STANDARD_DEVIATION 49.0 • n=16 Participants
|
|
Left Ventricular End Diastolic Volume (LVEDV)
|
158.9 mL
STANDARD_DEVIATION 46.3 • n=16 Participants
|
PRIMARY outcome
Timeframe: 30-daySuccessful implantation of the MitraClip NT device resulting in a decrease in the MR severity grade as assessed from the discharge echocardiogram (10-day echocardiogram will be used if discharge is unavailable or uninterpretable). Subjects who die or undergo mitral valve surgery before discharge will be considered a failure for the procedure
Outcome measures
| Measure |
MitraClip
n=16 Participants
Subject will receive MitraClip procedure with MitraClip NT System
MitraClip Procedure: MitraClip procedure with MitraClip NT System
|
|---|---|
|
Number of Patients With Successful Implantation of the MitraClip NT Device
|
15 Participants
|
Adverse Events
MitraClip
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
MitraClip
n=16 participants at risk
Subject will receive MitraClip procedure with MitraClip NT System
MitraClip Procedure: MitraClip procedure with MitraClip NT System
|
|---|---|
|
General disorders
Iatrogenic ASD with Complications
|
6.2%
1/16 • Number of events 1 • 30 Days
|
|
General disorders
Stroke
|
6.2%
1/16 • Number of events 1 • 30 Days
|
|
General disorders
Cardiac arrest takotsubo cardiomyopathy
|
6.2%
1/16 • Number of events 1 • 30 Days
|
|
General disorders
Pneumonia
|
6.2%
1/16 • Number of events 1 • 30 Days
|
Other adverse events
| Measure |
MitraClip
n=16 participants at risk
Subject will receive MitraClip procedure with MitraClip NT System
MitraClip Procedure: MitraClip procedure with MitraClip NT System
|
|---|---|
|
General disorders
Single Leaflet Device Attachment (SLDA)
|
6.2%
1/16 • Number of events 1 • 30 Days
|
|
General disorders
furuncle on chest
|
6.2%
1/16 • Number of events 1 • 30 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place