Health TrialsbyHealthPanel

Early Transcatheter Mitral Valve Repair After Myocardial Infarction

ConditionAcute Mitral Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorFundación para la Investigación Biosanitaria del Principado de Asturias

About this trial

To explore the impact of early transcatheter edge-to-edge repair of acute functional mitral regurgitation after myocardial infarction on the combined incidence of death and heart-failure associated hospitalisations at one-year follow-up, and quality of life and LV remodelling at two-year follow-up.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with symptomatic moderate to severe or severe MR after acute MI

Age > 18 years

Disqualifiers

Primary MR (e.g. papillary muscle rupture)

EF ≤ 25%

Accepted for CABG

Presence of cardiogenic shock (AMR type 1)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Early transcatheter edge-to-edge mitral valve repair (TEER).

    Procedure/Surgery

    TEER will be planned and performed as soon as possible, but within 60 days after index myocardial infarction, and within 30 days of randomisation using the MitraClip device.

  • MitraClip

    Device

    MitraClip

  • Optimal medical treatment

    Other intervention

    Optimal medical treatment

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: TEER + OMTExperimental treatment 3 interventions
Group B: OMTOther 1 intervention

Trial outcomes

Primary outcomes

1

All-cause death or Cumulative Heart Failure hospitalizations

Composite of 1. All-cause death 2. Cumulative Heart Failure hospitalizations

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundación para la Investigación Biosanitaria del Principado de Asturias

Lead sponsor

Meditrial Europe Ltd.

Collaborator

Source ClinicalTrials.gov
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