Mitral RegurgitationATLASNCT06465745
ATLAS (AltaValve) Pivotal Trial
A study testing AltaValve System. in people with Mitral Regurgitation and Mitral Insufficiency, run by 4C Medical Technologies, Inc. at 58 sites in 7 countries.
Trial summary
This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population. 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 System.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 58 sitesin 7 countries
- Study dates
- 3 Sep 2024to Sep 2031
- Phase
- Interventional
- 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
- Age ≥ 18 years.
- Symptomatic New York Heart Association (NYHA) class II-IV.
- Moderate-to-severe or severe MR (3+) despite optimal guideline-directed medical therapy (GDMT) as determined by an independent Echo Core Lab.
- Unsuitable for surgery and Transcatheter Edge-toEdge Repair (TEER) as determined by the local site Heart Team.
Who cannot join
- Inability to understand the trial or a history of non-compliance with medical advice.
- Inability to provide signed Informed Consent Form (ICF).
- History of any cognitive or mental health status that would interfere with participation in the trial.
- Currently enrolled in any other pre-approval investigational trial (does not apply to long-term post-market trials unless these trials might clinically interfere with the current trial endpoints (e.g., limit use of trial-required medication, etc.)).
- Female subjects who are pregnant or planning to become pregnant within the trial period.
- Known hypersensitivity or contraindication to heparin, or warfarin without adequate alternative medications.
Show all 12Show fewer
- 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) ≤ 25%.
- Concurrent medical condition with a life expectancy of less than 12 months.
- Transcatheter aortic repair or replacement within 90 days prior to the baseline required tests.
- Percutaneous coronary intervention (PCI) within 30 days prior to the index procedure.
Trial locations and contacts
58 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
58 sites in 7 countries
United States36 sites, 36 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Steven Bolling, 734-763-6551, ctsogroup@umich.edu
- Recruiting
Wellstar Center for Cardiovascular Care
Atlanta, Georgia, 30060
Nabil Sabbak, 770-424-6893, research@wellstar.org
- Recruiting
MedStar Health Research Institute, Inc.
Baltimore, Maryland, 21218
Brian Bethea, 410-554-2332, research@medstar.net
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Roger Laham, 617-667-4443, cto@bidmc.harvard.edu
- Recruiting
The Charlotte-Mecklenburg Hospital; Atrium Health
Charlotte, North Carolina, 28203
Michael Rinaldi, 800-821-1535, IRBInfo@AtriumHealth.org
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
John Saxon, (434) 924-3606, jgd7s@uvahealth.org
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Guilherme Attizzani, 833-788-7425, MCTU@UHhospitals.org
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Rishi Puri, 216-444-6731, lri-contact@ccf.org
- Recruiting
MedStar Health Research Institute, Inc.
Columbia, Maryland, 21044
Ron Waksman, 202-877-5975, JoinResearch@medstar.net
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Brian O'Neil, 313-970-6483, hsabbah1@hfhs.org
- Recruiting
East Carolina Heart Institute at East Carolina University
Greenville, North Carolina, 27834
Paul Mahoney, 252-744-4400, research@ecuhealth.org
- Recruiting
Cardiovascular Institute of the South
Houma, Louisiana, 70360
Peter Fail, MD, 985-876-0300, deanna.benoit@cardio.com
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Sukhdeep Basra, 713-500-3622, clinicaltrials@uth.tmc.edu
- Recruiting
Baptist Medical Center
Jacksonville, Florida, 32207
Siddharth Wayagankar, 904-398-0125, Almer.Mendoza@bmcjax.com
Doran Byers, Doran.Byers@bmcjax.com
- Recruiting
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Adnan Chhatriwalla, 816-931-1883, ahaley@saint-lukes.org
- Recruiting
Scripps Health
La Jolla, California, 92037
Curtiss Stinis, 858-824-4168, CRSLeadership@scrippshealth.org
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Raj Makkar, 310-423-3977, ClinicalTrials@cshs.org
- Recruiting
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Vinayak Bapat, 877-800-2729, info@mhif.org
- Recruiting
AHS Hospital Corp.
Morristown, New Jersey, 07960
Phillippe Genereux, 973-971-5000, research@atlantichealth.org
- Recruiting
NCH Healthcare System
Naples, Florida, 34102
Robert Cubeddu, 239-624-8113, kathy.byrd@nchmd.org
- Recruiting
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York, 10032
Susheel Kodali, (212) 305-7060, sk2427@cumc.columbia.edu
Kate Dalton, (212) 305-7060, keb2114@cumc.columbia.edu
- Recruiting
South Oklahoma Heart Research, LLC.
Oklahoma City, Oklahoma, 73135
Naeem Tahirkheli, 405-628-6000, research@okheart.com
- Recruiting
Orange County Heart Institute & Research Center
Orange, California, 92868
Brian Kolski, 714-564-3300, Jessica.Serna@providence.org
- Recruiting
Banner University Medical Center
Phoenix, Arizona, 85006
Paul Sorajja, 602-521-3090, PBC-TREO-CR@arizona.edu
- Recruiting
Abrazo Arizona Heart Hospital
Phoenix, Arizona, 85016
Timothy Byrne, 602-952-002, jessica.byrne@abrazohealth.com
- Recruiting
Dignity Health; St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85032
Hursh Naik, 602-406-1150, DHRIAZ@DignityHealth.org
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Firas Zahr, 503-346-0811, octrirecruitment@ohsu.edu
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Charanjit Rihal, 800-664-4542, clinicaltrials@mayo.edu
- Recruiting
William Beaumont Hospital
Royal Oak, Michigan, 48073
Amr Abbas, 248-551-1235, Rachael.Campbell@corewellhealth.org
- Recruiting
Sutter Bay Hospitals
San Francisco, California, 94107
David Daniels, 415-600-1051, milena.ferreira@sutterhealth.org
- Recruiting
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
Ricardo Yaryura, 941-917-2225, ResearchInstitute@smh.com
- Recruiting
University of Washington
Seattle, Washington, 98195
James McCabe, 206-543-0098, hsdreprt@uw.edu
- Recruiting
Washington University
St Louis, Missouri, 63110
Alan Zajarias, 314-747-6800, hrpo@wustl.edu
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Mohamed Azeem Latib, 718-920-2000, oct@montefiore.org
- Recruiting
Los Robles Hospital & Medical Center
Thousand Oaks, California, 91360
Saibal Kar, 805-796-7836, Claire.Hozinsky@hcahealthcare.com
- Recruiting
TMC Healthcare
Tucson, Arizona, 85712
Thomas Waggoner, 520-420-2136, clinicalresearch@tmcaz.com
Germany8 sites, 8 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin
Christoph Klein, +49 30 450 565 855, ship@dhzc-charite.de
- Recruiting
Universitatsklinikum Bonn
Bonn
Georg Nickenig, +49 228 287 14305, KAR.Studienambulanz@ukbonn.de
- Recruiting
University Hospital Cologne - Heart Center
Cologne
Matti Adam, +49 221 47832401, matti.adam@uk-koeln.de
- Recruiting
Cardiac Research GmbH; St.-Johannes-Hospital Dortmund
Dortmund
Helge Mollmann, +49 (0231) 1843-35100, inneremedizin1@joho-dortmund.de
- Recruiting
Universitätsmedizin der Johannes Gutenberg Universität Mainz
Mainz
Tobias Ruf, +49 6131-176794, Studienzentrum-zfk@unimedizin-mainz.de
- Recruiting
University Hospital of the Ruhr University Bochum
Oeynhausen
Volker Rudolph, +49 5731 971276, vrudolph@hdz-nrw.de
- Recruiting
Heart Center Trier
Trier
Nikos Werner, +49 651 208 2776, h.waschbuesch@bbtgruppe.de
- Recruiting
Universitiitsklinikum Ulm
Ulm, 50937
Wolfgang Rottbauer, +49 731/500-45001, Wolfgang.Rottbauer@uniklinik-ulm.de
France4 sites, 4 recruiting
- Recruiting
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33404
Lionel Leroux, +33 (0) 05 24 54 93 70, umcv.recherche@chu-bordeaux.fr
- Recruiting
L'Assistance Publique-Hôpitaux de Marseille (AP-HM)
Marseille, 13554
Thomas Cuisset, +33 04 91 38 60 15, aurelie.blondelon@ap-hm.fr
- Recruiting
Société d'Exploitation du Centre Cardiologique du Nord
Paris
Mohammed Nejjari, +33 (0)6 79 14 51 44, m.nejjari@ccn.fr
- Recruiting
Clinique Pasteur
Toulouse, 31076
Didier Tchétché, +33 05 62 21 16 99, dtchetche@clinique-pasteur.com
Canada3 sites, 3 recruiting
- Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, G1V 4G5
Josep Rodés Cabau, 418-656-8711, Josep.Rodes@criucpq.ulaval.ca
- Recruiting
St. Michael's Unity Health Toronto
Toronto, Ontario, M5B 1W8
Niel Farm, 416-864-6060, research@phc.ca
- Recruiting
St. Paul's Hospital
Vancouver, British Colombia, V6Z 2K5
Robert Boone, 604-806-8804, Robert.boone@phc.ca
Greece3 sites, 3 recruiting
- Recruiting
Onassis Cardiac Surgery Center
Athens
Ioannis Iakovou, +30 2109493000, kard_tomeas@ocsc.gr
ananou@cc.uoi.gr
- Recruiting
Univeristy Hospital of Ioannina
Ioannina
Lampros Michalis, +30 6936643448, aidrammos@yahoo.gr
Nanou, +30 2651007843
- Recruiting
Interbalkan Medical Center of Thessaloniki
Thessaloniki
Vlasis Ninios, +30 6948596047, vninios@gmail.com
Sosanna Konstantinidou, +306972364852, konstantinidousosanna@gmail.com
Spain3 sites, 3 recruiting
- Recruiting
Hospital Clinic de Barcelona
Barcelona
Ander Regueiro, +34 628094871, AREGUEIR@clinic.cat
- Recruiting
Fundación para la investigación biomédica del hospital clínico San Carlos
Madrid
Luis Nombela, +34 917044596, mollyanna.march.externo@salud.madrid.org
- Recruiting
Hospital Álvaro Cunqueiro
Vigo
Rodrigo Estevez, +34 986825564, rodrigo.estevez.loureiro@sergas.es
Poland1 site, 1 recruiting
- Recruiting
Uniwersyteckim Szpitalem Klinicznym
Poznan, 60-355
Marek Grygier, +48 61 854 92 23, mgrygier@wp.pl
+48 61 854 91 93
About this study
Official title: ATLAS (A Transseptal Left Atrial System for Treatment of Mitral Regurgitation) Pivotal Trial
This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence, Mitral Valve Regurgitation, Mitral Incompetence
- Being tested
- AltaValve System.
- Keywords
- Mitral Regurgitation, TMVR, Functional Regurgitation, Degenerative Regurgitation, Transcatheter 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.
AltaValve System.Device
Transcatheter Mitral Valve Replacement.
| Study group | Role | What they receive |
|---|---|---|
| Primary Cohort | Experimental | Designed to evaluate the safety and performance of the AltaValve System for the treatment of moderate-to-severe or severe MR in a targeted patient population without at least moderate mitral annular calcification (MAC). Receives: Device: AltaValve System. |
| Mitral Annular Calcification Cohort (MAC) | Experimental | Designed to evaluate the safety and performance of the AltaValve System for the treatment of moderate-to-severe or severe MR in a targeted patient population with moderate to severe MAC. Receives: Device: AltaValve System. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause mortality or heart failure hospitalization.
Measured: 12 months.
Secondary outcomes (6)
All-cause mortality, disabling stroke, acute kidney injury (stage 3 or with renal replacement), mitral valve re-intervention (surgical or transcatheter), major bleeding requiring intervention.
Composite.
Measured: 30 Days or hospital discharge (whichever is longer).
Technical success.
Technical success will be considered achieve when all of the following are present:
- Successful application of the delivery system as intended.
- Successful device placement.
- Reduction in mitral regurgitation grade to ≤ 2+.
Measured: Day 0.
Mitral valve re-intervention.
Mitral valve re-intervention after index procedure
Measured: At 30 days, 6 months, 1 year, and annually thereafter for up to 5 years.
Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ).
Quality of life improvement.
Measured: 6 months and 1 year.
Changes in Six-minute walk test (6MWT).
Quality of life improvement.
Measured: 6 months and 1 year.
New pacemaker rate.
Measured: 1 month, 6 months and 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start3 Sep 2024
- Primary completionSep 2029 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 4C Medical Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465745
- Sponsor's protocol ID
- 5472
- Acronym
- ATLAS
- Status last verified
- Jul 2026
- First submitted
- 5 Jun 2024
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ATLAS (A Transseptal Left Atrial System for Treatment of Mitral Regurgitation) Pivotal Trial
- ClinicalTrials.gov ID
- NCT06465745
- Acronym / sponsor ID
- ATLAS / 5472
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence, Mitral Valve Regurgitation, Mitral Incompetence
- Keywords
- Mitral Regurgitation, TMVR, Functional Regurgitation, Degenerative Regurgitation, Transcatheter Mitral Valve Replacement, Primary Regurgitation, Secondary Regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- 4C Medical Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 20 Jun 2024 (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 is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Cohort | Experimental | Device: AltaValve System.Designed to evaluate the safety and performance of the AltaValve System for the treatment of moderate-to-severe or severe MR in a targeted patient population without at least moderate mitral annular calcification (MAC). |
| Mitral Annular Calcification Cohort (MAC) | Experimental | Device: AltaValve System.Designed to evaluate the safety and performance of the AltaValve System for the treatment of moderate-to-severe or severe MR in a targeted patient population with moderate to severe MAC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Symptomatic New York Heart Association (NYHA) class II-IV.
- Moderate-to-severe or severe MR (3+) despite optimal guideline-directed medical therapy (GDMT) as determined by an independent Echo Core Lab.
- Unsuitable for surgery and Transcatheter Edge-toEdge Repair (TEER) as determined by the local site Heart Team.
Key exclusion criteria (12 listed)
- Inability to understand the trial or a history of non-compliance with medical advice.
- Inability to provide signed Informed Consent Form (ICF).
- History of any cognitive or mental health status that would interfere with participation in the trial.
- Currently enrolled in any other pre-approval investigational trial (does not apply to long-term post-market trials unless these trials might clinically interfere with the current trial endpoints (e.g., limit use of trial-required medication, etc.)).
- Female subjects who are pregnant or planning to become pregnant within the trial period.
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 |
|---|---|---|
| AltaValve System.Transcatheter Mitral Valve Replacement. | Device | Mitral Annular Calcification Cohort (MAC), Primary Cohort |
Primary outcome
Composite of all-cause mortality or heart failure hospitalization.
Time frame: 12 months.
6 secondary outcomes
All-cause mortality, disabling stroke, acute kidney injury (stage 3 or with renal replacement), mitral valve re-intervention (surgical or transcatheter), major bleeding requiring intervention.
Time frame: 30 Days or hospital discharge (whichever is longer).
Technical success.
Time frame: Day 0.
Mitral valve re-intervention.
Time frame: At 30 days, 6 months, 1 year, and annually thereafter for up to 5 years.
Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ).
Time frame: 6 months and 1 year.
Changes in Six-minute walk test (6MWT).
Time frame: 6 months and 1 year.
New pacemaker rate.
Time frame: 1 month, 6 months and 1 year.
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 3 Aug 2026.
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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.
Dignity Health; St. Joseph's Hospital and Medical Center
Phoenix, United States
58 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AltaValve System. in people with Mitral Regurgitation and Mitral Insufficiency, run by 4C Medical Technologies, Inc. at 58 sites in 7 countries.
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 4 inclusion and 12 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 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, Germany, France, Canada, Greece and 2 more countries. 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?
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?
Composite of all-cause mortality or heart failure hospitalization. (time frame: 12 months.). 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 3 Aug 2026.