Mitral Valve ReplacementEarly Phase 1NCT07601269
Replacement of the Native Mitral Valve Using the ReValve System
A Early Phase 1 study testing ReValve System in people with Mitral Valve Replacement, run by ReValve Solutions Inc. at 2 sites in Brazil.
Trial summary
This study is to collect preliminary chronic information on performance and safety of the ReValve System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Replacement
- What is being tested?
- ReValve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesBrazil
- Study dates
- 26 Apr 2026to Apr 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 2 recruiting
- Recruiting
Institute Dante Pazzanese of Cardiology - IDPC
São Paulo, São Paulo, SP, 04012-909
Study Coordinator, +55 11 5085-6000, diretoriageral@dantepazzanese.org.br
- Recruiting
The Heart Institute - INCOR
São Paulo, São Paulo, SP, 05403-900
Study Coordinator, +55 11 2661-5000, larissa.katipian@hc.fm.usp.br
About this study
Official title: A Clinical Study Evaluating the Replacement of the Native Mitral Valve Using the ReValve System
This study is to collect preliminary chronic information on performance and safety of the ReValve System.
- Conditions
- Mitral Valve Replacement
- Being tested
- ReValve System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReValve SystemDevice
Mitral Valve Replacement Device
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Study | Experimental | Device: ReValve System Receives: Device: ReValve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success
The Technical Success, is defined as the successful delivery of the ReValve Palmetto Valve and withdrawal of the delivery system
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start26 Apr 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ReValve Solutions Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601269
- Sponsor's protocol ID
- CIP-002 Brazil
- Status last verified
- May 2026
- First submitted
- 16 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Replacement of the Native Mitral Valve Using the ReValve System
- ClinicalTrials.gov ID
- NCT07601269
- Acronym / sponsor ID
- CIP-002 Brazil
- Conditions
- Mitral Valve Replacement
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- ReValve Solutions Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to collect preliminary chronic information on performance and safety of the ReValve System.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Study | Experimental | Device: ReValve SystemDevice: ReValve System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReValve SystemMitral Valve Replacement Device | Device | Single Arm Study |
Primary outcome
Technical Success
Time frame: Procedure
The Technical Success, is defined as the successful delivery of the ReValve Palmetto Valve and withdrawal of the delivery system
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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The REValve Clinical Trial an Evaluation Of the ReValve Palmetto Valve for the Replacement of the Native Mitral VaLVE
Mitral Regurgitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Institute Dante Pazzanese of Cardiology - IDPC
São Paulo, Brazil
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ReValve System in people with Mitral Valve Replacement, run by ReValve Solutions Inc. at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success (time frame: Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.