18 and older, any sex, with Mitral Valve Insufficiency. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Major Adverse Events (MAEs)Primary· 30 days
Composite rate of all-cause death, myocardial infarction, stroke, heart failure hospitalization, or complication requiring transcatheter or surgical intervention (repeat transcatheter edge-to-edge repair \[TEER\] or mitral valve surgery)
Composite MAE
Group
Value
95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System
9
All-cause death
Group
Value
95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System
2
Myocardial infarction
Group
Value
95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System
0
Stroke
Group
Value
95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System
1
Heart failure hospitalization
Group
Value
95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System
5
Complication requiring transcatheter or surgical intervention (repeat TEER or mitral valve surgery)
Group
Value
95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System
2
Mitral Regurgitation (MR) Reduction to <=2+Primary· 30 days, 12 months
MR severity assessed by sites using a 5-grade scale: none/trace (0-1+), mild (1+), mild to moderate (2+), moderate to severe (3+), and severe (4+).
30 days
Group
Value
95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System
155
12 months
Group
Value
95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System
122
Quality of Life, as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary ScoresSecondary· Baseline, 30 days, 12 months
KCCQ is a 23-item, self-administered, validated questionnaire that quantifies physical function, symptoms, social function, self-efficacy, and quality of life for patients with heart failure. Scores range from 0 to 100 with higher scores indicating better function (100 = no symptoms, no limitations, and excellent quality of life).
Baseline
Group
Value
95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System
45.3
± 19.93
30 Days
Group
Value
95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System
59.1
± 20.89
12 Months
Group
Value
95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System
71.0
± 21.83
Quality of Life, as Assessed by EQ-5D Visual Analog Scale (VAS)Secondary· Baseline, 30 days, 12 months
Patient's self-rated health on a visual analog scale (0-100 points; 0=worst health you can imagine and 100=best health you can imagine).
Baseline
Group
Value
95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System
51.9
± 18.16
30 Days
Group
Value
95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System
60.6
± 17.77
12 Months
Group
Value
95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System
61.6
± 20.21
New York Heart Association (NYHA) Functional ClassificationSecondary· Baseline, 30 days, 12 months
NYHA Functional Classification is a 4-category system commonly used by physicians to assess patient heart failure symptoms based on limitations to physical activity:
Class I - No symptoms and no limitation in ordinary physical activity. Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.
Class IV - Severe limitations. Experiences symptoms even while at rest.
Baseline
Group
Value
95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System
3
Edwards PASCAL Transcatheter Mitral Valve Repair System
33
Edwards PASCAL Transcatheter Mitral Valve Repair System
161
Edwards PASCAL Transcatheter Mitral Valve Repair System
19
30 Days
Group
Value
95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System
29
Edwards PASCAL Transcatheter Mitral Valve Repair System
89
Edwards PASCAL Transcatheter Mitral Valve Repair System
64
Edwards PASCAL Transcatheter Mitral Valve Repair System
1
12 Months
Group
Value
95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System
28
Edwards PASCAL Transcatheter Mitral Valve Repair System
73
Edwards PASCAL Transcatheter Mitral Valve Repair System
67
Edwards PASCAL Transcatheter Mitral Valve Repair System
1
6-Minute Walk Test (6MWT)Secondary· Baseline, 30 days, 12 months
6MWT is a submaximal exercise test that measures the distance that a patient can walk on a flat surface in a period of 6 minutes.
Baseline
Group
Value
95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System
275.5
± 116.16
30 Days
Group
Value
95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System
292.9
± 119.92
12 Months
Group
Value
95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System
310.2
± 108.30
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Edwards PASCAL Transcatheter Mitral Valve Repair System
Serious: 82/220 (37%)
Deaths: 19/220
Serious adverse events (18 terms)
Reaction
System
Edwards PASCAL Transcathet…
Readmission - Heart Failure
Cardiac disorders
—
Readmission - Cardiac (not Heart Failure)
Cardiac disorders
—
Readmission - Non-Cardiac (Follow Up)
Surgical and medical procedures
—
Unplanned Other Cardiac Surgery or Intervention (Not Mitral Valve Re-Intervention)
Surgical and medical procedures
—
New Requirement for Dialysis
Renal and urinary disorders
—
Mitral Valve Re-Intervention
Surgical and medical procedures
—
Other Device Related Event
Product Issues
—
Major Bleeding Event
Vascular disorders
—
Atrial Septal Defect (ASD) Closure Due to Transseptal Catheterizaton
Injury, poisoning and procedural complications
—
Complication Requiring Transcatheter or Surgical Intervention
Surgical and medical procedures
—
Other Bleed
Vascular disorders
—
Myocardial Infarction
Cardiac disorders
—
Bleeding at Access Site
Injury, poisoning and procedural complications
—
Hematoma at Access Site
Injury, poisoning and procedural complications
—
Major Vascular Complication
Injury, poisoning and procedural complications
—
Single Leaflet Device Attachment
Product Issues
—
Unplanned Vascular Surgery or Intervention (for Bleeding or Access Site Complication)
This registry will collect prospective and retrospective clinical data on patients treated with the Edwards PASCAL Transcatheter Valve Repair System outside of the Post-Market Clinical Follow-up (PMCF) study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Edwards Lifesciences
Last refreshed: 26 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04443218.