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MiCLASP Post Market Clinical Follow-Up (PMCF) Study (MiCLASP)

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ClinicalTrials.gov Identifier: NCT04430075
Recruitment Status : Recruiting
First Posted : June 12, 2020
Last Update Posted : August 3, 2021
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief 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.

Condition or disease Intervention/treatment
Mitral Regurgitation Mitral Insufficiency Device: Edwards PASCAL Transcatheter Valve Repair System

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transcatheter Repair of Mitral Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post Market Clinical Follow-Up (PMCF)
Actual Study Start Date : August 23, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2026

Intervention Details:
  • Device: Edwards PASCAL Transcatheter Valve Repair System
    Transcatheter Valve Repair with Edwards PASCAL System


Primary Outcome Measures :
  1. Number of patients with major adverse events (MAE rates) [ Time Frame: 30 days ]
    The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days

  2. Change in mitral regurgitation severity (scale of 0-4+) by echocardiography [ Time Frame: Discharge: defined as discharge or 7 days post-procedure, whichever comes first ]
    Mitral regurgitation severity will be assessed by echocardiography at timepoint discharge on a scale from 0-4+ and compared to timepoint baseline Mitral regurgitation severity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at or over the age of 18 determined to require percutaneous reconstruction of an insufficient mitral valve (MR ≥ 2+) by a Heart Team who assesses patient risk and anatomic suitability should be considered for inclusion in this trial.
Criteria

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 cm² 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04430075


Contacts
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Contact: TMTT Clinical Affairs +1 (949) 250 ext 2500 TMTT_Clinical@edwards.com

Locations
Show Show 39 study locations
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Philipp Lurz, Prof.Dr.med. Heart Centre of the University Leipzig
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT04430075    
Other Study ID Numbers: 2018-08
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: August 3, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases