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Mitral RegurgitationEXPLORE MRNCT04098328

Early Feasibility EXperience of Posterior Leaflet RestOration to REduce Mitral Regurgitation

An observational study of Mitral Regurgitation and Mitral Valve Disease, run by Polares Medical SA at 3 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Early feasibility study, single-arm registry design Read more about this study

Who is it for?
Ages 18 years and older
How many people
2 participants
Where
3 sitesin 2 countries
Study dates
1 Jan 2020to 2 Feb 2023
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

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: Inoperable or high surgical risk patients with symptomatic degenerative or functional mitral regurgitation (Grade 3+ or higher) with mitral valve anatomy deemed unsuitable, or off-label, to be treated with an approved edge-to-edge repair system.

Who may be able to join

  • 18 years of age or older.
  • Greater than moderate degenerative or functional mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure
  • Patient must present with an STS Score less than 10%
  • High surgical risk for conventional mitral repair or replacement due to morphological criteria (e.g. leaflet or annulus calcifications) as assessed by the local heart team comprised of a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease and heart failure
  • Mitral valve anatomy deemed unsuitable to be treated with an approved edge-to-edge repair system (e.g., retracted posterior leaflet, lack of leaflet tissue, calcified or cleft posterior leaflet) as assessed by the local heart team comprised of a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease and heart failure
  • Patient is approved by an independent Patient Eligibility Committee
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  • New York Heart Association (NYHA) Functional Class III or IV
  • Patient willing to participate in study and provide signed EC-approved informed consent.
  • Treating physician and patient agree that patient is able to return for all required post- procedure follow-up visits
  • Women of child-bearing potential have a negative pregnancy test

Who cannot join

  • Severe tricuspid regurgitation
  • Severe aortic stenosis or insufficiency
  • Severe mitral annulus calcification
  • Diseased mitral anterior leaflet such as flail / prolapse/ heavy calcification
  • Implanted vena cava filter
  • Femoral veins with severe angulation and calcification
Show all 31Show fewer
  • Contraindication for transesophageal echocardiography (TEE) or MDCT scan.
  • Active infection or endocarditis
  • Previous mitral valve surgery
  • Prior orthotopic heart transplantation
  • Pulmonary artery systolic hypertension > 70mmHg
  • Evidence of intra-cardiac, inferior vena cava (IVC) or femoral venous thrombus
  • Left ventricular ejection fraction (LVEF) < 30%
  • Implant or revision of any pacing device < 30 days prior to intervention
  • Symptomatic coronary artery disease treated < 30 days prior to study procedure
  • Myocardial infarction requiring intervention < 30 days prior to study procedure
  • Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis), hypertrophic or restrictive cardiomyopathies, and constrictive pericarditis
  • Active peptic ulcer or upper gastrointestinal bleeding < 90 days prior to study procedure
  • Stroke < 180 days prior to study procedure
  • Severe renal insufficiency (creatinine > 3.0 mg/dL) or patient requiring dialysis
  • Cardiogenic shock at time of enrolment
  • Hemodynamic instability requiring inotropic support or mechanical heart assistance
  • Concurrent medical condition with a life expectancy of less than 2 years
  • Pregnancy at time of enrolment
  • History of bleeding diathesis or coagulopathy or leukopenia (WBC < 3,000 mcL) or acute anemia (Hb < 9 g/dL) or thrombocytopenia (platelets < 50,000 cells mcL)
  • Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be pre-medicated
  • Severe dementia or lack of capacity due to conditions that result in either inability to provide informed consent for the trial/procedure, prevent independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up assessments
  • Emergency situations
  • Company employees or their immediate family members
  • Patient is under guardianship
  • Patient is participating in another clinical study for which follow-up is currently ongoing

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Switzerland2 sites

  • Inselspital Bern

    Bern, 3010

  • Luzerner Kantonsspital

    Lucerne

Other trials in Switzerland

Germany1 site

  • St. Johannes Hospital

    Dortmund

Other trials in Germany

About this study

Official title: Early Feasibility EXperience of Posterior Leaflet RestOration to REduce Mitral Regurgitation (EXPLORE MR)

Early feasibility study, single-arm registry design

Read the detailed description

First-In-Human

Medical subject headings
Mitral Valve Insufficiency

What is being measured

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

  1. Primary safety endpoint

    All-cause mortality

    Measured: 30 days

  2. Improvement from baseline mitral regurgitation

    Grade 2+ or less as evaluated by 2D transthoracic echocardiography

    Measured: 30 days

Secondary outcomes (5)

  1. Technical success according to MVARC2 criteria

    • Absence of procedure mortality
    • Successful access, delivery and retrieval of investigation delivery system
    • Successful deployment and correct positioning of intended implant(s)
    • Freedom from emergency surgery/re-intervention related to device or access procedure

    Measured: 24 hours

  2. Procedure success according to MVARC2 criteria

    • Absence of procedure mortality or stroke
    • Proper placement and positioning of device
    • Freedom from unplanned re-intervention related to device or access procedure
    • Continued intended safety and performance of the device:
    • No evidence of structural or functional failure
    • No device technical failure issues/complications
    • MR reduction to moderate or less without stenosis
    • Absence of major device or procedure-related SAE:
    • Death
    • Stroke
    • Life-threatening bleed
    • Major vascular complication
    • Major cardiac structural complication
    • No device technical failure issues/complications
    • Stage 2 or 3 AKI
    • MI or coronary ischemia requiring PCI or CABG
    • Shock, heart or respiratory failure requiring IV vasopressors, mechanical intervention or prolonged intubation
    • Valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention

    Measured: 30 days

  3. Device success according to MVARC2 criteria

    • Absence of procedure mortality or stroke
    • Proper placement and positioning of device
    • Freedom from unplanned re-intervention related to device or access procedure
    • Continued intended safety and performance of the device:
    • No evidence of structural or functional failure
    • No device technical failure issues/complications
    • MR reduction to moderate or less without stenosis

    Measured: 30 days, 6 and 12 months, and 2 - 5 years post treatment

  4. Patient success according to MVARC2 criteria

    • Device success
    • Patient returned to pre-procedure setting
    • No rehospitalization or reintervention for mitral regurgitation or heart failure
    • Functional improvement from baseline by one or more NYHA class
    • 6MWT improvement from baseline by 50 metres or more

    Measured: 30 days, 6 and 12 months, and 2 - 5 years post treatment

  5. Rate (%) of major adverse events as defined by MVARC2 criteria

    All-cause mortality, hospitalization due to cardiac conditions, stroke or TIA, myocardial infarction, access site and vascular complications, bleeding complications, acute kidney injury up to 7 days post-procedure, and arrhythmias and conduction system disturbances

    Measured: Procedure, discharge/7 days, 30 days, 6 and 12 months, and 2 - 5 years post treatment

Timeline

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

  1. First posted23 Sep 2019
  2. Study start1 Jan 2020
  3. Primary completion2 Feb 2023
  4. Study completion2 Feb 2023

Why it stopped: Study device refinement

Resources

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
2 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04098328
Sponsor's protocol ID
201901
Acronym
EXPLORE MR
Status last verified
Feb 2022
First submitted
17 Sep 2019
Last updated
18 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Mitral Regurgitation and Mitral Valve Disease, run by Polares Medical SA at 3 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 10 inclusion and 31 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: stopped early, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Switzerland, Germany. 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?

The study was stopped early (reason given: Study device refinement). Results are not available in the source record.

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?

Primary safety endpoint (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 NCT04098328.

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 18 Dec 2023.

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