xMedica

NCT04820764ClinicalTrials.gov

EFS of the CardioMech MVRS

Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS)

RecruitingTaking participants now, according to the registry record.
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In brief

Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.

Interventional25 participants sought12 sites1 country

Categories

Cardiovascular100%

Registered in 1 registry

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2021-03-29; recorded start 2021-07-27
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are not randomly assignedAllocation is recorded as non-randomised
  • A comparison group is not stated in the registry recordThe record describes a single study arm
  • Open label (no blinding)Masking is recorded as none (open label)
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • No other studies from this sponsor are in this databaseCounted from the lead sponsor named in the record (CardioMech AS)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation0/20

    Allocation not stated in the record

  • Blinding0/20

    Open-label

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 12 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScalePILOT

A pilot-scale study: 25 participants (target), run at 12 sites.

How this score is built
  • Enrolment11/40

    25 participants (target)

  • Site count13/25

    12 sites

  • Country count0/15

    Single country

  • Planned duration10/10

    Planned over about 123 months

  • Sponsor scale0/10

    CardioMech AS has led 1 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.

The purpose of the clinical study is to obtain clinical data on the CardioMech Mitral Valve Repair System (MVRS) in patients diagnosed with moderate to severe (≥3+) or severe (≥4+), symptomatic, degenerative mitral regurgitation and who are determined to be at intermediate or high surgical risk for mitral valve repair, as assessed by the site's multidisciplinary heart team.

Conditions

  • Mitral Regurgitation

Eligibility

SexAll
Ages18 Years – No maximum
Healthy volunteersNo

Eligibility as written in the registry

Inclusion Criteria: * Eighteen (18) years of age or greater * Moderate to severe (≥3+) or severe (≥4+) mitral valve regurgitation (per American Society of Echocardiography (ASE) guidelines) due to mitral valve prolapse or flail * Intermediate or high surgical risk for mitral valve repair Exclusion Criteria: * History of rheumatic heart disease * History of prior endocarditis * History of prior repair or replacement of the mitral valve, or annuloplasty * Severely calcified mitral leaflet or has evidence of calcification in the grasping area of the leaflets that would prevent leaflet anchor positioning and deployment * Complex mechanism of MR (leaflet perforation, severe leaflet calcifications, commissural extension, commissural prolapse, multiple flail or prolapsing segments, cleft) present on required imaging

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study typeInterventional
PhaseNot applicable
AllocationNot applicable
Intervention modelSINGLE_GROUP
Primary purposeDEVICE_FEASIBILITY
MaskingNONE (0)
Enrolment25 participants sought

Sponsor and collaborators

  • CardioMech AS Sponsor

Arms and interventions

  • CardioMech Mitral Valve Repair System (MVRS)EXPERIMENTAL

Interventions

  • Device CardioMech MVRS

    CardioMech MVRS

Outcome measures

  1. Primary outcome

    Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure

    Time frame 30 days

  2. Primary outcome

    Change in MR grade

    Time frame 30 days

Dates

Start dateJuly 27, 2021 (actual)
Primary completionSeptember 1, 2026 (estimated)
CompletionSeptember 1, 2031 (estimated)
First postedMarch 29, 2021 (actual)
Last updatedFebruary 10, 2026
Results postedNot stated in the registry record
Status last verifiedJanuary 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

10 sites are recruiting

United States

FacilityCityState or regionStatus
Atrium Health Sanger Heart and Vascular InstituteCharlotteNorth CarolinaActive, not recruiting
The Christ HospitalCincinnatiOhioRecruiting
Cleveland ClinicClevelandOhioRecruiting
Northwestern UniversityEvanstonIllinoisRecruiting
Intermountain Medical CenterMurrayUtahRecruiting
Ascension St. Thomas WestNashvilleTennesseeRecruiting
NYU LangoneNew YorkNew YorkRecruiting
Baylor Scott & White, The Heart HospitalPlanoTexasRecruiting
Mayo ClinicRochesterMinnesotaRecruiting
CentraCare Heart & Vascular CenterSaint CloudMinnesotaRecruiting
Cardiovascular Institute of Los Robles Health SystemThousand OaksCaliforniaActive, not recruiting
Ascension St. Francis via ChristiWichitaKansasRecruiting

Study documents

No documents are linked in this registry record.

Changes over time

No changes have been recorded since we first ingested this record.

A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT04820764