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Prospective Analysis of the Feasibility of the PASCAL Spacer Technology for Transcatheter Mitral Valve Repair in an All-comers Cohort (OneForAll)

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ClinicalTrials.gov Identifier: NCT04473092
Recruitment Status : Recruiting
First Posted : July 16, 2020
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Peter Lüdike, University Hospital, Essen

Brief Summary:
To identify changes on mitral valve morphology and functionality by the application of the PascalTM in MR.

Condition or disease Intervention/treatment
Mitral Regurgitation Device: TMVR

Detailed Description:
Transcatheter mitral valve repair (TMVR) in mitral regurgitation (MR) is increasingly applied in patients on high surgical risk. Interventional mitral valve repair can be applied is routinely applied in primary and secondary mitral regurgitation. While the edge-to-edge technique has been the solely available technlology in the marked for the last years, the recently introduced PascalTM technology represents a novel concept and is characterized by a central spacer, wider paddles, and larger dimensions. Implications of implantation of the PascalTM device on the mitral valve morphology and functionality concerning potential changes on mitral regurgitation as well as changes on mitral valve orifice area are to date not fully understood. The current study will identify anatomical changes to optimize ideal patient selection and optimal treatment approaches of the PASCALTM device.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Prospective Analysis of the Feasibility of the PASCAL Spacer Technology for Transcatheter Mitral Valve Repair in an All-comers Cohort
Actual Study Start Date : July 20, 2020
Estimated Primary Completion Date : August 21, 2022
Estimated Study Completion Date : September 30, 2022

Intervention Details:
  • Device: TMVR
    Patients who undergo TMVR for MR at the PI´s site


Primary Outcome Measures :
  1. Morphologic and functional changes of mitral valve anatomy [ Time Frame: 1 year ]


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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
All patients who undergo TVMR for MR (age >18yrs) at the PI´s site
Criteria

Inclusion Criteria:

• All patients who undergo TVMR for MR (age >18yrs) at the PI´s site

Exclusion Criteria:

  • <18yry
  • Subject does not provide full consent

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): NCT04473092


Contacts
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Contact: Peter Lüdike, MD +4920172384809 peter.luedike@uk-essen.de

Locations
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Germany
University Hospital Essen, Westgerman Heart and Vascular Center, Department of Cardiology and Vascular Medicine Recruiting
Essen, NRW, Germany, 45147
Contact: Peter Lüdike         
Sponsors and Collaborators
University Hospital, Essen
Investigators
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Principal Investigator: Peter Lüdike, MD University Hospital Essen, Westgerman Heart- and Vascular Center, Department of Cardiology and Vascular Medicine
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Responsible Party: Peter Lüdike, Prof. Dr., University Hospital, Essen
ClinicalTrials.gov Identifier: NCT04473092    
Other Study ID Numbers: 20-9223-BO
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 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: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases