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NCT Number: NCT07108907

Outcome Registry and Assessment of New Edge-to-Edge Repair

The goal of this observational study is to learn about the long-term effects of Edge-tot-edge repair of all the patients of AmsterdamUMC, to treat their Mitral regurgitation (MR). The main question it aims to answer is:

The patient selection process could be optimized. Participants are already receiving edge-to-edge repair as part of their standard medical care and will additionally complete quality-of-life survey questions.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam UMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location status: Recruiting

Location contact

Abby E Geerlings, MD

CONTACT

[email protected]

+31205669467

About this study

Mitral regurgitation (MR) affects more than 10% of individuals over the age of 75, and with an aging population, its prevalence is expected to continue rising in the coming years. Treatment options include surgical repair, surgical replacement, medical therapy, cardiac resynchronization therapy (CRT), or transcatheter valve repair. For percutaneous mitral valve repair, the transcatheter edge-to-edge repair (M-TEER) technique is the preferred approach. This technique involves the use of the MitraClip (Abbott) and PASCAL (Edwards) devices, which are derived from the surgical Alfieri technique.

Since 2009, the M-TEER procedure has been performed in patients who, based on assessment by the heart team and mitral valve team, are deemed unsuitable for surgery but are eligible for this percutaneous treatment.

Using data from all patients undergoing M-TEER at Amsterdam UMC, the investigators aim to conduct research focused on improving patient selection and alleviating symptoms associated with mitral valve disease.

Who can participate

Healthy volunteers accepted: No

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

Eligibility Criteria

Inclusion criteria

Age ≥ 18 years
Accepted for M-TEER (Minimally Invasive Transcatheter Edge-to-Edge Repair) procedure

Exclusion criteria

Unable to complete the questionnaires

Treatment and study plan

Primary outcomes

Change in quality of life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

Time frame: Baseline and 6 months

Change in health-related quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 6 months. The KCCQ is a validated, disease-specific instrument measuring physical function, symptoms, social limitations, and quality of life in patients with heart failure. Scores range from 0 to 100, with higher scores indicating better health status.

Unit of Measure: KCCQ score (0-100)
Change in quality of life measured by the 36-Item Short Form Survey (SF-36)

Time frame: Baseline and 6 months

Change in health-related quality of life as assessed by the 36-Item Short Form Survey (SF-36) from baseline to 6 months. The SF-36 is a validated, generic instrument assessing physical and mental health across 8 domains. Scores are standardized to a 0-100 scale, with higher scores indicating better perceived health.

Unit of Measure: SF-36 score (0-100)

Study contacts

Contact information is provided by the study sponsor or research team.

Abby E Geerlings, MD

CONTACT

[email protected]

+31205669467

Sponsors and collaborators

Lead sponsor

Abby Geerlings

Other

Registry information

Official study title

ORANGE- TEER (Outcome Registry and Assessment of New Edge-to-Edge Repair)

Acronym: ORANGE-TEER

Important dates

Study start: 2025
Primary completion: 2030
Study completion: 2035
First posted: Aug 7, 2025
Registry last updated: Aug 7, 2025

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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