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OpenTrials
Completed

NCT Number: NCT04473092

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

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

Completed

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Key information

Conditions

Mitral Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Essen, Westgerman Heart and Vascular Center, Department of Cardiology and Vascular Medicine

Essen, North Rhine-Westphalia, 45147, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TMVR

Device

Patients who undergo TMVR for MR at the PI´s site

Primary outcomes

  1. Morphologic and functional changes of mitral valve anatomy

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Acronym: OneForAll

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 16, 2020
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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