NCT07601269 Replacement of the Native Mitral Valve Using the ReValve System
| NCT ID | NCT07601269 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | ReValve Solutions Inc. |
| Condition | Mitral Valve Replacement |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2026-04-26 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 25 participants in total. It began in 2026-04-26 with a primary completion date of 2028-04.
⚠ 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 study is to collect preliminary chronic information on performance and safety of the ReValve System.
Eligibility Criteria
Key Inclusion Criteria: * Symptomatic functional and/or degenerative MR (≥2+) due to ischemic and non-ischemic cardiomyopathy etiology determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 60 days and transesophageal echocardiogram (TEE) obtained within 90 days prior to subject registration, with MR severity based principally on the TTE study. * New York Heart Association (NYHA) Functional Class II, III or ambulatory IV. * Left Ventricular Ejection Fraction (LVEF) is ≥30% (within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac CT. * Age greater than 18 years. * Left Ventricular End Systolic Dimension (LVESD) is ≤ 65 mm assessed by site based on a transthoracic echocardiographic (TTE) obtained within 90 days prior to subject consent. Key Exclusion Criteria: * Untreated clinically significant coronary artery disease requiring revascularization. * Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months. * Status 1 heart transplant or prior orthotopic heart transplantation. * Cerebrovascular accident within 30 days prior to subject's consent. * Pregnant or planning pregnancy within next 12 months. * Currently participating in an investigational drug or another device study. * Evidence of LV or LA thrombus, vegetation or mass * Known hypersensitivity or contraindication to procedural, post procedural medication (e.g., contrast solution, anticoagulation therapy) or hypersensitivity to nickel or titanium.
Frequently Asked Questions
Who can join the NCT07601269 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mitral Valve Replacement. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07601269 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07601269 currently recruiting?
Yes, NCT07601269 is actively recruiting participants. Visit ClinicalTrials.gov or contact ReValve Solutions Inc. to inquire about joining.
Where is the NCT07601269 trial being conducted?
This trial is being conducted at São Paulo, Brazil, São Paulo, Brazil.
Who is sponsoring the NCT07601269 clinical trial?
NCT07601269 is sponsored by ReValve Solutions Inc.. The trial plans to enroll 25 participants.