Mitral Valve InsufficiencyPASCALRegistryNCT04443218

Edwards PASCAL Transcatheter Valve Repair System Registry

An observational study of Mitral Valve Insufficiency, run by Edwards Lifesciences at 14 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Mitral Valve Insufficiency
What is being tested?: Edwards PASCAL Transcatheter Valve Repair System
Type of treatment: Medical device
How many people: 220 participants
Where: 14 sitesin 2 countries
Study dates: 27 May 2019to 10 May 2021
How long will I take part?: 1 Year
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with Mitral Regurgitation eligible to receive the PASCAL device

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

14 sites in 2 countries.

Country

City, postcode or hospital

14 sites in 2 countries

Germany13 sites

Herz- und Diabeteszentrum NRW - Bad Oeynhausen
Bad Oeynhausen, North Rhine-Westphalia, 32545
Immanuel Klinikum Bernau
Bernau bei Berlin, Brandenburg, 16321
Herzzentrum der Universitätsklinik Bonn
Bonn, North Rhine-Westphalia, 53127
Herzzentrum Köln
Cologne, Nord Rhine Westphalia, 50937
St.-Johannes-Hospital Dortmund
Dortmund, North Rhine-Westphalia, 44137
Herzzentrum Universitätsklinik Dresden
Dresden, Saxony, 01307
Elisabeth-Krankenhaus Essen
Essen, North Rhine-Westphalia, 45138
Universitätsklinikum Gießen
Giessen, Hesse, 35392
Georg-August-Universität Göttingen, Universitätsmedizin Göttingen
Göttingen, Lower Saxony, 37075
Kath. Marienkrankenhaus Hamburg GmbH
Hamburg, 22087
Heart Centre of the University Leipzig
Leipzig, Saxony, 04289
Universitätsmedizin der Johannes Gutenberg Universität Mainz
Mainz, Rhineland-Palatinate, 55131
LMU Klinikum der Universität München
München, Bavaria, 81377

Other trials in Germany

Switzerland1 site

Inselspital Bern
Bern, 3010

Other trials in Switzerland

About this study

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

Read the 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.

Conditions: Mitral Valve Insufficiency
Being tested: Edwards PASCAL Transcatheter Valve Repair System
Medical subject headings: Mitral Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 30 days
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+).
Measured: 30 days, 12 months

Secondary outcomes (4)

Quality of Life, as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Scores
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).
Measured: Baseline, 30 days, 12 months
Quality of Life, as Assessed by EQ-5D Visual Analog Scale (VAS)
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).
Measured: Baseline, 30 days, 12 months
New York Heart Association (NYHA) Functional Classification
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.
Measured: Baseline, 30 days, 12 months
6-Minute Walk Test (6MWT)
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.
Measured: Baseline, 30 days, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 May 201910 May 2021

First posted23 Jun 2020
Study start27 May 2019
Primary completion10 May 2021
Study completion10 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Mitral Valve InsufficiencyStudies of the same condition, open and under way.
More trials run by Edwards LifesciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 220 participants (actual)
Target duration: 1 Year

IDs, dates and publications

ClinicalTrials.gov ID: NCT04443218
Sponsor's protocol ID: 2019-03
Acronym: PASCALRegistry
Status last verified: Feb 2024
First submitted: 1 Apr 2020
Last updated: 26 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population
Mitral Valve Insufficiency
RecruitingObservational study
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Heart Valve Diseases, Aortic Valve Stenosis
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Recruiting
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
Mitral Valve Regurgitation
Recruiting
MRS Measurement of Glutamate and GABA Metabolism in Brain
Normal Physiology

All Mitral Valve Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Edwards PASCAL Transcatheter Valve Repair System Registry: A Multicenter Observational Registry With the Edwards PASCAL Transcatheter Valve Repair System
ClinicalTrials.gov ID: NCT04443218
Acronym / sponsor ID: PASCALRegistry / 2019-03
Conditions: Mitral Valve Insufficiency
Study type: Observational
Recruitment status: Completed
Enrolment: 220 participants (actual)
Lead sponsor: Edwards LifesciencesIndustry (pharma, biotech, devices)
Study start: 27 May 2019 (actual)
Primary completion: 10 May 2021 (actual)
Study completion: 10 May 2021 (actual)
First posted: 23 Jun 2020 (actual)
Results: Posted 26 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Other
Target follow-up: 1 Year

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with Mitral Regurgitation eligible to receive the PASCAL device

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Edwards PASCAL Transcatheter Valve Repair SystemThe Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient mitral valve.	Device	–

Primary outcome

Major Adverse Events (MAEs)
Time frame: 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+
Time frame: 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+).

4 secondary outcomes

Quality of Life, as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Scores
Time frame: Baseline, 30 days, 12 months
Quality of Life, as Assessed by EQ-5D Visual Analog Scale (VAS)
Time frame: Baseline, 30 days, 12 months
New York Heart Association (NYHA) Functional Classification
Time frame: Baseline, 30 days, 12 months
6-Minute Walk Test (6MWT)
Time frame: Baseline, 30 days, 12 months

Results and safety

Results posted to the registry on 26 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Edwards PASCAL Transcatheter Mitral Valve Repair System	220	187

Primary outcome: Major Adverse Events (MAEs)

Time frame: 30 days. Count of participants. Unit: Participants

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n = 216
Composite MAE	9
All-cause death	2
Myocardial infarction	0
Stroke	1
Heart failure hospitalization	5
Complication requiring transcatheter or surgical intervention (repeat TEER or mitral valve surgery)	2

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

Primary outcome: Mitral Regurgitation (MR) Reduction to <=2+

Time frame: 30 days, 12 months. Count of participants. Unit: Participants

Measure	Edwards PASCAL Transcatheter Mitral Valve Repair System n = 191
30 days	155
12 months	122

Population analysed: Outcome data collected per standard of care at each investigative site and analyzed, if available. Analysis population includes participants with available data at one or more timepoints.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Edwards PASCAL Transcatheter Mitral Valve Repair System	82 of 220 (37.3%)	0 of 220 (0%)	19 of 220

Limitations and caveats (from the sponsor): Interpretation of some outcome measures is limited by significant incomplete and/or missing data due to retrospective data collection, differences in data collected as part of standard of care across sites, and use of alternative follow-up data collection methods in lieu of in-person clinical visits. Additionally, this registry did not use an echocardiography core laboratory to assess echocardiography parameters or a clinical events committee to adjudicate adverse events.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Mitral Valve Insufficiency

RecruitingObservational study
Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population
Mitral Valve Insufficiency
RecruitingObservational study
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Heart Valve Diseases, Aortic Valve Stenosis
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Recruiting
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
Mitral Valve Regurgitation
Recruiting
MRS Measurement of Glutamate and GABA Metabolism in Brain
Normal Physiology

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joerg Hausleiter, Prof. principal investigator

14 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Mitral Valve Insufficiency, run by Edwards Lifesciences at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Events (MAEs) (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04443218.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.