Edwards PASCAL Transcatheter Valve Repair System Registry

Edwards PASCAL Transcatheter Valve Repair System Registry: A Multicenter Observational Registry With the Edwards PASCAL Transcatheter Valve Repair System

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04443218

Acronym

PASCALRegistry

Enrollment

220

Registered

2020-06-23

Start date

2019-05-27

Completion date

2021-05-10

Last updated

2024-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Valve Insufficiency

Brief summary

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.

Detailed description

Patients treated per standard of care at their medical facilities and a written informed consent will be collected to allow the data to be collected. This registry intends to enroll patients under commercial usage and will serve as a mechanism to collect clinical data to further characterize the safety, performance and effectiveness of the PASCAL Transcatheter Valve Repair System.

Interventions

DEVICEEdwards PASCAL Transcatheter Valve Repair System

The Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient mitral valve.

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient signs informed consent to participate in the registry * Patient is intended to or has received the PASCAL device

Exclusion criteria

* Patient does not consent to participate * Patient is part of an ongoing Edwards Pre or Post Market Clinical study for the PASCAL Transcatheter Valve Repair System.

Design outcomes

Primary

Measure	Time frame	Description
Major Adverse Events (MAEs)	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)
Mitral Regurgitation (MR) Reduction to <=2+	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+).

Secondary

Measure	Time frame	Description
Quality of Life, as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Scores	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).
Quality of Life, as Assessed by EQ-5D Visual Analog Scale (VAS)	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).
New York Heart Association (NYHA) Functional Classification	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.
6-Minute Walk Test (6MWT)	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.

Countries

Germany, Switzerland

Participant flow

Participants by arm

Arm	Count
Edwards PASCAL Transcatheter Mitral Valve Repair System Mitral valve repair with PASCAL implanted via transcatheter procedure	220
Total	220

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	19
Overall Study	Exited study for other reasons	9
Overall Study	Lost to Follow-up	4
Overall Study	Withdrawal by Subject	1

Baseline characteristics

Characteristic	Edwards PASCAL Transcatheter Mitral Valve Repair System	—
Age, Continuous	77.2 years STANDARD_DEVIATION 9.61	—
Body Mass Index	26.2 kg/m^2 STANDARD_DEVIATION 5.15	—
EuroScore II	7.6 % STANDARD_DEVIATION 8.2	—
Mitral Regurgitation (MR) Etiology Degenerative MR	85 Participants	—
Mitral Regurgitation (MR) Etiology Functional MR	106 Participants	—
Mitral Regurgitation (MR) Etiology Mixed MR	23 Participants	—
Mitral Regurgitation (MR) Etiology Other	4 Participants	—
Mitral Regurgitation (MR) Severity Mild (1+)	0 Participants	—
Mitral Regurgitation (MR) Severity Mild to Moderate (2+)	1 Participants	—
Mitral Regurgitation (MR) Severity Moderate to Severe (3+)	137 Participants	—
Mitral Regurgitation (MR) Severity None/Trace (0-1+)	0 Participants	—
Mitral Regurgitation (MR) Severity Severe (4+)	82 Participants	—
New York Heart Association (NYHA) Functional Class Class I	3 Participants	—
New York Heart Association (NYHA) Functional Class Class II	33 Participants	—
New York Heart Association (NYHA) Functional Class Class III	161 Participants	—
New York Heart Association (NYHA) Functional Class Class IV	19 Participants	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Female	82 Participants	—
Sex: Female, Male Male	138 Participants	—
STS Score for Mitral Valve Repair	4.1 % STANDARD_DEVIATION 3.11	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	19 / 220
other Total, other adverse events	0 / 220
serious Total, serious adverse events	82 / 220

Outcome results

Primary

Major Adverse Events (MAEs)

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)

Time frame: 30 days

Population: Analysis includes patients who had an MAE or who were followed for at least 30 days. Patients may experience more than one MAE.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Edwards PASCAL Transcatheter Mitral Valve Repair System	Major Adverse Events (MAEs)	All-cause death	2 Participants
Edwards PASCAL Transcatheter Mitral Valve Repair System	Major Adverse Events (MAEs)	Myocardial infarction	0 Participants
Edwards PASCAL Transcatheter Mitral Valve Repair System	Major Adverse Events (MAEs)	Stroke	1 Participants
Edwards PASCAL Transcatheter Mitral Valve Repair System	Major Adverse Events (MAEs)	Heart failure hospitalization	5 Participants
Edwards PASCAL Transcatheter Mitral Valve Repair System	Major Adverse Events (MAEs)	Composite MAE	9 Participants
Edwards PASCAL Transcatheter Mitral Valve Repair System	Major Adverse Events (MAEs)	Complication requiring transcatheter or surgical intervention (repeat TEER or mitral valve surgery)	2 Participants

Primary

Mitral Regurgitation (MR) Reduction to <=2+

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+).

Time frame: 30 days, 12 months