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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07108907

Acronym

ORANGE-TEER

Enrollment

300

Registered

2025-08-07

Start date

2025-07-10

Completion date

2035-01-01

Last updated

2025-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Regurgitation

Keywords

Mitraclip

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Change in quality of life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)	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)	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)

Countries

Netherlands

Contacts

Primary ContactAbby E Geerlings, MD

a.e.geerlings@amsterdamumc.nl+31205669467

Outcome results