Mitral RegurgitationMiCLASPNCT04430075
MiCLASP Post Market Clinical Follow-Up (PMCF) Study
An observational study of Mitral Regurgitation and Mitral Insufficiency, run by Edwards Lifesciences at 37 sites in 9 countries.
Trial summary
This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter mitral valve repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Mitral Insufficiency
- What is being tested?
- Edwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair System
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 37 sitesin 9 countries
- Study dates
- 23 Aug 2019to 31 Mar 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 at or over the age of 18 determined to require percutaneous reconstruction of an insufficient mitral valve [MR ≥ 2+ (PASCAL patients) or MR ≥ 3+ (PASCAL Precision patients)] by a Heart Team who assesses patient risk and anatomic suitability should be considered for inclusion in this trial.
Who may be able to join
- Mitral TEER patients eligible per the current approved indication after Heart Team discussion and agreement
- Patient is willing and able to attend all follow-up visits and to perform all tests
- Provision of written informed consent
Who cannot join
- Patients are not eligible per the current Instructions for Use
- Non-elective or emergency TEER procedure for mitral regurgitation
- Patients in ICU prior to the index procedure
Trial locations and contacts
37 sites in 9 countries.
37 sites in 9 countries
Germany26 sites
Zentralklinik Bad Berka GmbH
Bad Berka, 99438
Universitäts-Herzzentrum Freiburg Campus Bad Krozingen
Bad Krozingen, Baden-Wurttemberg, 79189
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
Bad Oeynhausen, North Rhine-Westphalia, 32545
Charité Berlin
Berlin, 10117
Charité Berlin
Berlin, 13353
Immanuel Klinikum Bernau
Bernau bei Berlin, Brandenburg, 16321
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 32545
Herzzentrum Universitaetsklinik Herzzentrum Universitaetsklinik Cologne
Cologne, North Rhine-Westphalia, 50937
St.-Johannes-Hospital
Dortmund, North Rhine-Westphalia, 44137
Herzzentrum Universitätsklinik Dresden
Dresden, Saxony, 01307
Uniklinikum Erlangen
Erlangen, Bavaria, 91054
Westdeutsches Herzzentrum / Uniklinik Essen
Essen, Nordrhine Westfalia, 45122
Contilia Herz- und Gefäßzentrum,Elisabeth-Krankenhaus Essen
Essen, Nordrhine Westfalia, 45138
MVZ-CCB
Frankfurt, 60389
Universitätsklinikum Giessen UKGM
Giessen, Hesse, 35392
Universitaeres Herzzentrum Goettingen
Göttingen, Lower Saxony, 37075
Universitares Herzzentrum Hamburg
Hamburg, 20246
Kath. Marienkrankenhaus Hamburg GmbH
Hamburg, 22087
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105
Heart Centre of the University Leipzig
Leipzig, 04289
Universitäres Herzzentrum Lübeck, Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
Universitätsmedizin der Johannes Gutenberg Universität Mainz
Mainz, North Rhine-Westphalia, 55313
Medizinische Klinik I- Campus Grosshadern
München, Bavaria, 81377
Helios Klinikum Siegburg
Siegburg, North Rhine-Westphalia, 53721
Universität Tuebingen
Tübingen, Baden-Wurttemberg, 72074
Uniklinikum Ulm
Ulm, Baden-Wurttemberg, 89081
Italy3 sites
Ospedale del Cuore G. Pasquinucci Massa
Massa, 54100
IRCCS Ospedale San Raffaele
Milan, Lombardy, 20132
IRCCS Policlinico San Donato
San Donato Milanese, 20097
Netherlands2 sites
St. Antonius Ziekenhuis
Nieuwegein, 3435
Erasmus MC
Rotterdam, 3015
Poland1 site
The Cardinal Stefan Wyszyński, Institute of Cardiology
Warsaw, 04-628
About this study
Official title: Transcatheter Repair of Mitral Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post Market Clinical Follow-Up (PMCF)
This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter mitral valve repair.
Read the detailed description
The objectives of this clinical study are to collect data on the safety of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter mitral valve repair and on the effectiveness of the Edwards PASCAL System and Edwards PASCAL Precision System in improving MR, functional status and quality of life in a post market setting.
- Conditions
- Mitral Regurgitation, Mitral Insufficiency
- Being tested
- Edwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision 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 System and Edwards PASCAL Precision Transcatheter Valve Repair SystemDevice
Transcatheter Valve Repair with Edwards PASCAL and PASCAL Precision System
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with major adverse events (MAE rates)
The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days
Measured: 30 days
Change in mitral regurgitation severity (scale of 0-4+) by echocardiography
Mitral regurgitation severity will be assessed by echocardiography at timepoint discharge on a scale from 0-4+ and compared to timepoint baseline Mitral regurgitation severity
Measured: Discharge: defined as discharge or 7 days post-procedure, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start23 Aug 2019
- Primary completion4 Sep 2025
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitral RegurgitationStudies 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philipp Lurz, Prof.Dr.med., Principal investigator, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430075
- Sponsor's protocol ID
- 2018-08
- Acronym
- MiCLASP
- Status last verified
- Jul 2026
- First submitted
- 19 Dec 2019
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mahabadi AA, Rassaf T, Kister T, Schmitz T, Geisler T, Lubos E, Hausleiter J, Eitel I, von Bardeleben RS, Berti S, Linke A, Hengstenberg C, Rudolph V, Unsold B, Denti P, Baldus S, Nickenig G, Mollman H, Spargias K, Brambilla N, Butter C, Rottbauer W, Reinthaler M, Swaans M, Praz F, Witkowski A, Van Mieghem NM, Buch M, Wolf F, Edelmann F, Marcoff L, Koulogiannis K, Lurz P; MiCLASP Study Investigators. One-Year Outcomes of M-TEER With the PASCAL System in Atrial and Ventricular FMR: Insights From the MiCLASP Postmarket Clinical Follow-Up Study. Circ Cardiovasc Interv. 2026 Aug 25:e016563. doi: 10.1161/CIRCINTERVENTIONS.126.016563. Online ahead of print.
PubMed 42639648
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Repair of Mitral Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post Market Clinical Follow-Up (PMCF)
- ClinicalTrials.gov ID
- NCT04430075
- Acronym / sponsor ID
- MiCLASP / 2018-08
- Conditions
- Mitral Regurgitation, Mitral Insufficiency
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 4 Sep 2025 (actual)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter mitral valve repair.
Detailed description
The objectives of this clinical study are to collect data on the safety of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter mitral valve repair and on the effectiveness of the Edwards PASCAL System and Edwards PASCAL Precision System in improving MR, functional status and quality of life in a post market setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at or over the age of 18 determined to require percutaneous reconstruction of an insufficient mitral valve [MR ≥ 2+ (PASCAL patients) or MR ≥ 3+ (PASCAL Precision patients)] by a Heart Team who assesses patient risk and anatomic suitability should be considered for inclusion in this trial.
Key inclusion criteria (3 listed)
- Mitral TEER patients eligible per the current approved indication after Heart Team discussion and agreement
- Patient is willing and able to attend all follow-up visits and to perform all tests
- Provision of written informed consent
Key exclusion criteria (3 listed)
- Patients are not eligible per the current Instructions for Use
- Non-elective or emergency TEER procedure for mitral regurgitation
- Patients in ICU prior to the index procedure
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 System and Edwards PASCAL Precision Transcatheter Valve Repair SystemTranscatheter Valve Repair with Edwards PASCAL and PASCAL Precision System | Device | – |
Primary outcome
Number of patients with major adverse events (MAE rates)
Time frame: 30 days
The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days
Change in mitral regurgitation severity (scale of 0-4+) by echocardiography
Time frame: Discharge: defined as discharge or 7 days post-procedure, whichever comes first
Mitral regurgitation severity will be assessed by echocardiography at timepoint discharge on a scale from 0-4+ and compared to timepoint baseline Mitral regurgitation severity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Derived from this study: PubMed 42639648Mahabadi AA, Rassaf T, Kister T, Schmitz T, Geisler T, Lubos E, Hausleiter J, Eitel I, von Bardeleben RS, Berti S, Linke A, Hengstenberg C, Rudolph V, Unsold B, Denti P, Baldus S, Nickenig G, Mollman H, Spargias K, Brambilla N, Butter C, Rottbauer W, Reinthaler M, Swaans M, Praz F, Witkowski A, Van Mieghem NM, Buch M, Wolf F, Edelmann F, Marcoff L, Koulogiannis K, Lurz P; MiCLASP Study Investigators. One-Year Outcomes of M-TEER With the PASCAL System in Atrial and Ventricular FMR: Insights From the MiCLASP Postmarket Clinical Follow-Up Study. Circ Cardiovasc Interv. 2026 Aug 25:e016563. doi: 10.1161/CIRCINTERVENTIONS.126.016563. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Philipp Lurz, Prof.Dr.med. principal investigator
Johannes Gutenberg University Mainz
37 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation and Mitral Insufficiency, run by Edwards Lifesciences at 37 sites in 9 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Germany, Italy, Netherlands, Austria, Greece and 4 more countries. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of patients with major adverse events (MAE rates) (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 NCT04430075, which also lists 1 linked publication.
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 19 Aug 2026.