MiCLASP Post Market Clinical Follow-Up (PMCF) Study

  • STATUS
    Recruiting
  • End date
    Dec 5, 2026
  • participants needed
    300
  • sponsor
    Edwards Lifesciences
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Updated on 16 February 2024
See if I qualify
regurgitation
walk test
mitral valve repair

Summary

This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in transcatheter mitral valve repair.

Description

The objectives of this clinical study are to collect data on the safety of the Edwards PASCAL Transcatheter Valve Repair System in transcatheter mitral valve repair and on the effectiveness of the Edwards PASCAL System in improving MR and improving functional status and quality of life in a post market setting.

Details
Condition VALVULAR HEART DISEASE, Mitral Regurgitation
Age 18years - 100years
Treatment Edwards PASCAL Transcatheter Valve Repair System
Clinical Study IdentifierNCT04430075
SponsorEdwards Lifesciences
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age greater than or equal to 18 years
Patient is determined to require percutaneous reconstruction of an insufficient mitral valve (MR greater than or equal to 2+ ) by a Heart Team who assesses patient risk and anatomic suitability
Patient is eligible to receive the PASCAL device per the current approved indications for use
Minimum 6 minutes walk test of 150m. This criteria applies only to patients presenting with primarily functional mitral valve regurgitation
Patient is willing and able to attend all follow up visits and to perform all tests

Exclusion Criteria

Patient in whom a transesophageal echocardiography is contraindicated or screening transesophageal echocardiography is unsuccessful
Leaflet anatomy which may preclude PASCAL device implantation, proper device positioning on the leaflets, or sufficient reduction in mitral regurgitation
Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
LVEDD > 8.0 cm determined by transthoracic echocardiography within 60 days prior to submission
Contraindication to transseptal catheterization
Presence of an occluded or thrombosed Inferior vena cava filter that would interfere with the delivery catheter, or ipsilateral deep vein thrombosis is present
Mitral valve area (MVA) < 4.0 cm as measured by planimetry (If MVA by planimetry is not measurable, PHT measurement is acceptable)
Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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