NCT04430075 MiCLASP Post Market Clinical Follow-Up (PMCF) Study
| NCT ID | NCT04430075 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Edwards Lifesciences |
| Condition | Mitral Regurgitation |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2019-08-23 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2019-08-23 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter mitral valve repair.
Eligibility Criteria
Inclusion Criteria: 1. Mitral TEER patients eligible per the current approved indication after Heart Team discussion and agreement 2. Patient is willing and able to attend all follow-up visits and to perform all tests 3. Provision of written informed consent Exclusion Criteria: 1. Patients are not eligible per the current Instructions for Use 2. Non-elective or emergency TEER procedure for mitral regurgitation 3. Patients in ICU prior to the index procedure
Contact & Investigator
Philipp Lurz, Prof.Dr.med.
PRINCIPAL INVESTIGATOR
Johannes Gutenberg University Mainz
Frequently Asked Questions
Who can join the NCT04430075 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mitral Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04430075 currently recruiting?
Yes, NCT04430075 is actively recruiting participants. Contact the research team at TMTT_Clinical@edwards.com for enrollment information.
Where is the NCT04430075 trial being conducted?
This trial is being conducted at Vienna, Austria, Bad Krozingen, Germany, Tübingen, Germany, Ulm, Germany and 11 additional locations.
Who is sponsoring the NCT04430075 clinical trial?
NCT04430075 is sponsored by Edwards Lifesciences. The principal investigator is Philipp Lurz, Prof.Dr.med. at Johannes Gutenberg University Mainz. The trial plans to enroll 1,000 participants.