Mitral RegurgitationNCT03997305
AltaValve Early Feasibility Study Protocol
A study testing AltaValve in people with Mitral Regurgitation and Mitral Insufficiency, run by 4C Medical Technologies, Inc. at 12 sites in United States.
Trial summary
Prospective, single-arm, multicenter study to evaluate the safety and performance of the AltaValve for the treatment of moderate to severe or severe mitral valve regurgitation in subjects who are considered high risk for mortality and morbidity from conventional open-heart surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence
- What is being tested?
- AltaValve
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 12 sitesUnited States
- Study dates
- 4 Dec 2019to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subjects ≥ 18 years of age.
- Subjects symptomatic New York Heart Association (NYHA) II-IV.
- Subjects with severe MR as documented by echo.
- Subjects who are at high risk for open-heart surgery as documented by the health care professional (e.g., Heart Team consisting of cardiac surgeon and interventional cardiologist in United States).
- Abbreviated Exclusion Criteria:
- Inability to understand the study or a history of non-compliance with medical advice.
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- Unwilling or unable to sign the Informed Consent Form (ICF).
- History of any cognitive or mental health status that would interfere with study participation.
- Currently enrolled in any other pre-approval investigational study (does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.)).
- Female subjects who are pregnant or planning to become pregnant within the study period.
- Known hypersensitivity or contraindication to aspirin, heparin, or Warfarin without adequate alternative medications.
- Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.
- Known hypersensitivity to contrast media that cannot be adequately medicated.
- Evidence of current Left Ventricular Ejection Fraction (LVEF) ≤30% (where current is defined as the latest LVEF measurement completed within 90 days prior to the index procedure).
- Concurrent medical condition with a life expectancy of less than 12 months.
- Prior mitral valve repair/replacement (excluding prior surgical mitral valve repair, annuloplasty, or MitraClip not interfering with AltaValve placement).
Who cannot join
None listed.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30308
Elizabeth Charles, 404-686-1249, elizabeth.z.charles@emory.edu
Gaetano Paone, MD, MHSA
- Recruiting
Atrium Health
Charlotte, North Carolina, 28203
Dana Amaro, RN, 704-355-4692, Dana.Amaro@atriumhealth.org
Michael Rinaldi, MD, FACC
- Recruiting
Cardiovascular Institute of the South
Houma, Louisiana, 70360
Jennifer Aucoin, LPN, Jennifer.Aucoin@cardio.com
Peter Fail, MD, FACC
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Melissa Alanis, BSN, RN-BC, 713-441-3629, imalanis@houstonmethodist.org
Sachin Goel, MD
- Recruiting
Baptist Memorial Hospital - Memphis
Memphis, Tennessee, 38120
Kari Fondren, RN, 901-271-4062, kari.fondren@sterncardio.com
H. Edward Garret, MD
- Recruiting
Morristown Medical Center
Morristown, New Jersey, 07960
Catherine VanZile, 201-787-2254, catherine.vanzile@atlantichealth.org
Philippe Genereux, MD
- Recruiting
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73135
Julie White, 405-628-6865, juliewhite@okheart.com
Bruce Cannon, MD
- Recruiting
Baylor Scott & White
Plano, Texas, 75093
Alexandra Finley, 469-814-4235, Alexandra.Finley@BSWHealth.org
Molly Szerlip, MD
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
Tatyana Harris, 813-250-2392, trharris1@usf.edu
Hiram Bezerra, MD
- Recruiting
Los Robles Regional Medical Center
Thousand Oaks, California, 91360
Mane Arabyan, 805-796-3746, Mane.Arabyan@hcahealthcare.com
Saibal Kar, MD
- Recruiting
Tucson Medical Center
Tucson, Arizona, 85712
Ariana Ehsan, MD, 520-324-5207, Ariana.Ehsan@tmcaz.com
Tom Waggoner, DO
- Recruiting
MedStar Washington Hospital
Washington D.C., District of Columbia, 20010
Erin C Collins, MPH, 202-877-6622, erin.c.collins@medstar.net
Ron Waksman, MD, FACS
About this study
Prospective, single-arm, multicenter study to evaluate the safety and performance of the AltaValve for the treatment of moderate to severe or severe mitral valve regurgitation in subjects who are considered high risk for mortality and morbidity from conventional open-heart surgery.
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence, Mitral Valve Regurgitation, Mitral Incompetence
- Being tested
- AltaValve
- Keywords
- Mitral Regurgitation, TMVR, Functional Regurgitation, Degenerative Regurgitation, Transcathether Mitral Valve Replacement, Primary Regurgitation, Secondary Regurgitation
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AltaValveDevice
Transcatheter Mitral Valve Replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Event
Cardiac death, stroke, mitral valve related repeated intervention
Measured: 30 days
Secondary outcomes (4)
Technical success
Technical Success per MVARC criteria
Measured: Index procedure completion (Day 0)
Procedural success
Device success and absence of major device or procedure related serious adverse events
Measured: 30 days
Device success
Device Success per MVARC criteria
Measured: 30 days
Change in MR grade
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start4 Dec 2019
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitral RegurgitationStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 4C Medical Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Genereux, MD, Principal investigator, Morristown Medical CenterVinayak Bapat, MD, Principal investigator, Allina Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997305
- Sponsor's protocol ID
- 1890
- Status last verified
- Aug 2023
- First submitted
- 21 Jun 2019
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Genereux P, Wrobel K, Ninios V, Grygier M, Tahirkheli N, Sorajja P, Rinaldi MJ, Reardon MJ, Zembala MO, Bezerra HG, Waggoner TE, Giustino G, Waksman R, Grayburn P, Bapat V. 6-Month Outcomes of a Supra-Annular Transcatheter Mitral Valve Replacement: An Early Feasibility Study. JACC Cardiovasc Interv. 2025 Nov 10;18(21):2584-2592. doi: 10.1016/j.jcin.2025.08.040.
PubMed 41224388
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AltaValve Early Feasibility Study Protocol
- ClinicalTrials.gov ID
- NCT03997305
- Acronym / sponsor ID
- 1890
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence, Mitral Valve Regurgitation, Mitral Incompetence
- Keywords
- Mitral Regurgitation, TMVR, Functional Regurgitation, Degenerative Regurgitation, Transcathether Mitral Valve Replacement, Primary Regurgitation, Secondary Regurgitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- 4C Medical Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 25 Jun 2019 (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.
Prospective, single-arm, multicenter study to evaluate the safety and performance of the AltaValve for the treatment of moderate to severe or severe mitral valve regurgitation in subjects who are considered high risk for mortality and morbidity from conventional open-heart surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Subjects ≥ 18 years of age.
- Subjects symptomatic New York Heart Association (NYHA) II-IV.
- Subjects with severe MR as documented by echo.
- Subjects who are at high risk for open-heart surgery as documented by the health care professional (e.g., Heart Team consisting of cardiac surgeon and interventional cardiologist in United States).
- Inability to understand the study or a history of non-compliance with medical advice.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| AltaValveTranscatheter Mitral Valve Replacement | Device | – |
Primary outcome
Major Adverse Cardiac Event
Time frame: 30 days
Cardiac death, stroke, mitral valve related repeated intervention
4 secondary outcomes
Technical success
Time frame: Index procedure completion (Day 0)
Procedural success
Time frame: 30 days
Device success
Time frame: 30 days
Change in MR grade
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Derived from this study: PubMed 41224388Genereux P, Wrobel K, Ninios V, Grygier M, Tahirkheli N, Sorajja P, Rinaldi MJ, Reardon MJ, Zembala MO, Bezerra HG, Waggoner TE, Giustino G, Waksman R, Grayburn P, Bapat V. 6-Month Outcomes of a Supra-Annular Transcatheter Mitral Valve Replacement: An Early Feasibility Study. JACC Cardiovasc Interv. 2025 Nov 10;18(21):2584-2592. doi: 10.1016/j.jcin.2025.08.040.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Philippe Genereux, MD principal investigator
Morristown Medical Center
Vinayak Bapat, MD principal investigator
Allina Health System
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AltaValve in people with Mitral Regurgitation and Mitral Insufficiency, run by 4C Medical Technologies, Inc. at 12 sites in United States.
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 16 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adam Lawrence (+1-727-318-2203, AltaValveEFS@4CMed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Event (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03997305, which also lists 1 linked publication.
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 1 Sep 2023.