Health TrialsbyHealthPanel

The ENCIRCLE Trial

ConditionsMitral RegurgitationMitral Valve Insufficiency
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEdwards Lifesciences

About this trial

This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable.

Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age or older

MR ≥ 3+

NYHA functional class ≥ II

Per the Heart Team, commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations.

Disqualifiers

Mitral/cardiac anatomy that would preclude appropriate delivery and deployment of the SAPIEN M3 dock or valve

Inappropriate anatomy for femoral introduction and delivery of the SAPIEN M3 dock and valve

Presence of any device that will contact or interfere with the SAPIEN M3 System during delivery or after implantation

Left ventricular ejection fraction <25%

Trial design

Design model

Single group

Treatments tested in this trial

  • SAPIEN M3 valve and dock

    Device

    During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach.

Treatment groups

900 Participants
are divided into 3 treatment groups
Group A: TMVR - Main CohortExperimental treatment 1 intervention
Group B: TMVR - Failed TEER RegistryExperimental treatment 1 intervention
Group C: TMVR - MAC RegistryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Non-hierarchical composite of death and heart failure rehospitalization

Number of subjects with death and/or heart failure rehospitalization

Time frame
1 year

Secondary outcomes

1

Improvement in NYHA functional class compared to baseline

New York Heart Association (NYHA) functional classification of heart failure is based on how much a patient is limited during physical activity. The rating ranges from I-IV. I = no limitations of physical activity; II = slight limitations of physical activity, ordinary physical activity results in fatigue, palpitation, shortness of breath; III = marked limitations of physical activity, less than ordinary activity causes fatigue, palpitation, or shortness of breath; IV = unable to carry on any physical activity without discomfort, symptoms of heart failure at rest.

Time frame
1 year
2

Improvement in KCCQ Overall Score compared to baseline

The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

Time frame
1 year
3

Improvement in MR compared to baseline

Number of subjects with improved MR compared to baseline

Time frame
1 year
4

Decrease in LVEDVi compared to baseline

Number of subjects with decreased left ventricular end-diastolic volume index (LVEDVi) compared to baseline

Time frame
1 year

Other outcomes

Sponsors and contacts

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

Edwards Lifesciences

Lead sponsor

Source ClinicalTrials.gov
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