Trial Outcomes & Findings for Edwards CLASP TR EFS (NCT NCT03745313)
NCT ID: NCT03745313
Last Updated: 2025-09-29
Results Overview
Number and percentage of patients who experienced at least one major adverse event (MAE). Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction (MI), stroke, renal complications requiring unplanned dialysis or renal replacement therapy, severe bleeding, unplanned or emergency re-intervention related to the device, and major access site and vascular complications requiring intervention at 30 days.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
30 days
Results posted on
2025-09-29
Participant Flow
Participant milestones
| Measure |
Edwards PASCAL Transcatheter Tricuspid Valve Repair System
Tricuspid valve repair with PASCAL implanted via transcatheter procedure
|
|---|---|
|
At 30 Days Follow-up
STARTED
|
65
|
|
At 30 Days Follow-up
COMPLETED
|
63
|
|
At 30 Days Follow-up
NOT COMPLETED
|
2
|
|
At 6 Months Follow-up
STARTED
|
57
|
|
At 6 Months Follow-up
COMPLETED
|
54
|
|
At 6 Months Follow-up
NOT COMPLETED
|
3
|
|
At 1 Year Follow-up
STARTED
|
51
|
|
At 1 Year Follow-up
COMPLETED
|
47
|
|
At 1 Year Follow-up
NOT COMPLETED
|
4
|
|
At 2 Year Follow-up
STARTED
|
43
|
|
At 2 Year Follow-up
COMPLETED
|
42
|
|
At 2 Year Follow-up
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Edwards PASCAL Transcatheter Tricuspid Valve Repair System
Tricuspid valve repair with PASCAL implanted via transcatheter procedure
|
|---|---|
|
At 30 Days Follow-up
Death
|
2
|
|
At 6 Months Follow-up
Death
|
1
|
|
At 6 Months Follow-up
Missed Visit
|
1
|
|
At 6 Months Follow-up
Exited for Other Reason Within Window
|
1
|
|
At 1 Year Follow-up
Death
|
2
|
|
At 1 Year Follow-up
Missed Visit
|
2
|
|
At 2 Year Follow-up
Missed Visit
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Edwards PASCAL Transcatheter Tricuspid Valve Repair System
n=65 Participants
Tricuspid valve repair with PASCAL implanted via transcatheter procedure
|
|---|---|
|
Age, Continuous
|
77.4 Years
STANDARD_DEVIATION 8.93 • n=65 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=65 Participants
|
|
Body Mass Index
|
26.7 Kilogram Per Meter Squared
STANDARD_DEVIATION 5.81 • n=63 Participants • Data unavailable for 2 patients.
|
|
Tobacco Use
Current Daily Smoker
|
0 Participants
n=65 Participants
|
|
Tobacco Use
Former Daily Smoker
|
26 Participants
n=65 Participants
|
|
Tobacco Use
Never
|
39 Participants
n=65 Participants
|
|
NYHA Class
Class I
|
1 Participants
n=65 Participants
|
|
NYHA Class
Class II
|
18 Participants
n=65 Participants
|
|
NYHA Class
Class III
|
44 Participants
n=65 Participants
|
|
NYHA Class
Class IV
|
2 Participants
n=65 Participants
|
|
EuroSCORE II
|
5.0 Units on a scale
STANDARD_DEVIATION 4.69 • n=62 Participants • Data unavailable for 3 patients.
|
|
STS Mortality Score
|
7.4 Units on a scale
STANDARD_DEVIATION 5.21 • n=64 Participants • Data unavailable for 1 patient.
|
|
Clinical Frailty Total Score
Non-Frail
|
50 Participants
n=65 Participants
|
|
Clinical Frailty Total Score
Mild-to-Moderately Frail
|
15 Participants
n=65 Participants
|
|
Clinical Frailty Total Score
Severely Frail
|
0 Participants
n=65 Participants
|
|
Katz Activities of Daily Living Total Score
|
5.8 Units on a scale
STANDARD_DEVIATION 0.48 • n=65 Participants
|
|
Modified Rankin Scale
No symptoms at all
|
3 Participants
n=6 Participants • Data unavailable for 59 patients.
|
|
Modified Rankin Scale
No significant disability despite symptoms
|
2 Participants
n=6 Participants • Data unavailable for 59 patients.
|
|
Modified Rankin Scale
Moderate disability
|
1 Participants
n=6 Participants • Data unavailable for 59 patients.
|
PRIMARY outcome
Timeframe: 30 daysNumber and percentage of patients who experienced at least one major adverse event (MAE). Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction (MI), stroke, renal complications requiring unplanned dialysis or renal replacement therapy, severe bleeding, unplanned or emergency re-intervention related to the device, and major access site and vascular complications requiring intervention at 30 days.
Outcome measures
| Measure |
Edwards PASCAL Transcatheter Valve Repair System
n=65 Participants
Repair of the tricuspid valve through a transcatheter approach
|
|---|---|
|
Composite Major Adverse Event (MAE) Rate
|
6 Participants
|
SECONDARY outcome
Timeframe: IntraproceduralPopulation: Per device analysis
Number and percentage of Device Success, definition modified from MVARC criteria. Per device analysis
Outcome measures
| Measure |
Edwards PASCAL Transcatheter Valve Repair System
n=103 Device
Repair of the tricuspid valve through a transcatheter approach
|
|---|---|
|
Device Success
|
90 Device
|
SECONDARY outcome
Timeframe: Discharge (2-7 days)Population: The outcome is reported where data is available.
Number and percentage of patients who had Procedural Success, definition modified from MVARC criteria. Per patient analysis
Outcome measures
| Measure |
Edwards PASCAL Transcatheter Valve Repair System
n=56 Participants
Repair of the tricuspid valve through a transcatheter approach
|
|---|---|
|
Procedural Success
|
49 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: The outcome is reported where data is available.
Number and percentage of patients who had procedural success without MAEs at 30 days. Per patient analysis
Outcome measures
| Measure |
Edwards PASCAL Transcatheter Valve Repair System
n=56 Participants
Repair of the tricuspid valve through a transcatheter approach
|
|---|---|
|
Clinical Success
|
43 Participants
|
Adverse Events
Edwards PASCAL Transcatheter Valve Repair System
Serious events: 49 serious events
Other events: 57 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Edwards PASCAL Transcatheter Valve Repair System
n=65 participants at risk
Repair of the tricuspid valve through a transcatheter approach
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.7%
5/65 • Number of events 7 • 2 Years
|
|
Cardiac disorders
Atrial Fibrillation
|
6.2%
4/65 • Number of events 6 • 2 Years
|
|
Cardiac disorders
Cardiac Failure
|
12.3%
8/65 • Number of events 13 • 2 Years
|
|
Cardiac disorders
Cardiac Failure Congestive
|
15.4%
10/65 • Number of events 14 • 2 Years
|
|
Cardiac disorders
Tricuspid Valve Incompetence
|
7.7%
5/65 • Number of events 5 • 2 Years
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
6.2%
4/65 • Number of events 4 • 2 Years
|
|
General disorders
Death
|
7.7%
5/65 • Number of events 5 • 2 Years
|
|
Infections and infestations
Pneumonia
|
7.7%
5/65 • Number of events 6 • 2 Years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
20.0%
13/65 • Number of events 18 • 2 Years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
13.8%
9/65 • Number of events 12 • 2 Years
|
|
Nervous system disorders
Cerebrovascular Accident
|
6.2%
4/65 • Number of events 4 • 2 Years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
12.3%
8/65 • Number of events 10 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
7.7%
5/65 • Number of events 6 • 2 Years
|
|
Vascular disorders
Vascular Disorders
|
9.2%
6/65 • Number of events 6 • 2 Years
|
Other adverse events
| Measure |
Edwards PASCAL Transcatheter Valve Repair System
n=65 participants at risk
Repair of the tricuspid valve through a transcatheter approach
|
|---|---|
|
Cardiac disorders
Tricuspid Valve Incompetence
|
20.0%
13/65 • Number of events 13 • 2 Years
|
|
Cardiac disorders
Cardiac Failure Congestive
|
16.9%
11/65 • Number of events 15 • 2 Years
|
|
Cardiac disorders
Atrial Fibrillation
|
10.8%
7/65 • Number of events 9 • 2 Years
|
|
Cardiac disorders
Cardiac Failure Acute
|
7.7%
5/65 • Number of events 5 • 2 Years
|
|
Infections and infestations
COVID-19
|
9.2%
6/65 • Number of events 6 • 2 Years
|
|
Infections and infestations
Pneumonia
|
9.2%
6/65 • Number of events 8 • 2 Years
|
|
Infections and infestations
Urinary Tract Infection
|
9.2%
6/65 • Number of events 7 • 2 Years
|
|
Injury, poisoning and procedural complications
Fall
|
13.8%
9/65 • Number of events 9 • 2 Years
|
|
Injury, poisoning and procedural complications
Vascular Access Site Haemorrhage
|
6.2%
4/65 • Number of events 4 • 2 Years
|
|
Nervous system disorders
Syncope
|
9.2%
6/65 • Number of events 7 • 2 Years
|
|
Nervous system disorders
Cerebrovascular Accident
|
6.2%
4/65 • Number of events 4 • 2 Years
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
7.7%
5/65 • Number of events 5 • 2 Years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
23.1%
15/65 • Number of events 18 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
9.2%
6/65 • Number of events 7 • 2 Years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.7%
5/65 • Number of events 7 • 2 Years
|
|
Vascular disorders
Hypotension
|
9.2%
6/65 • Number of events 7 • 2 Years
|
|
Blood and lymphatic system disorders
Anaemia
|
10.8%
7/65 • Number of events 9 • 2 Years
|
|
Investigations
Investigations
|
12.3%
8/65 • Number of events 9 • 2 Years
|
|
Psychiatric disorders
Psychiatric Disorders
|
6.2%
4/65 • Number of events 5 • 2 Years
|
|
Surgical and medical procedures
Surgical and Medical Procedures
|
6.2%
4/65 • Number of events 4 • 2 Years
|
|
Cardiac disorders
Cardiac Failure
|
13.8%
9/65 • Number of events 14 • 2 Years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place