Recruiting

AltaValveATLAS (AltaValve) Pivotal Trial

Sponsor:

4C Medical Technologies, Inc.

Code:

NCT06465745

Conditions

Mitral Regurgitation

Mitral Insufficiency

Mitral Valve Incompetence

Mitral Valve Regurgitation

Mitral Incompetence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AltaValve System.

Study Details

Brief 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.

Conditions

Mitral Regurgitation

Mitral Insufficiency

Mitral Valve Incompetence

Mitral Valve Regurgitation

Mitral Incompetence

Study ID

NCT06465745

Start date

Sep 3, 2024

Status verified date

Jul, 2026

Completion date

Sep, 2031

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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.

Exclusion Criteria (Abbreviated List):

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.
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.

Study Design

Enrollment

450 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Primary Cohort

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).

experimental: Mitral Annular Calcification Cohort (MAC)

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.

Interventions

AltaValve System.

Transcatheter Mitral Valve Replacement.

Primary outcome measure

Composite of all-cause mortality or heart failure hospitalization. [ Time Frame: 12 months. ]

Central Contacts and Locations

Locations

Banner University Medical Center

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

Paul Sorajja

602-521-3090 PBC-TREO-CR@arizona.edu

Abrazo Arizona Heart Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Timothy Byrne

602-952-002 jessica.byrne@abrazohealth.com

Dignity Health; St. Joseph's Hospital and Medical Center

Recruiting

Phoenix, Arizona, United States, 85032

Contacts

Hursh Naik

602-406-1150 DHRIAZ@DignityHealth.org

TMC Healthcare

Recruiting

Tucson, Arizona, United States, 85712

Contacts

Thomas Waggoner

520-420-2136 clinicalresearch@tmcaz.com

Scripps Health

Recruiting

La Jolla, California, United States, 92037

Contacts

Curtiss Stinis

858-824-4168 CRSLeadership@scrippshealth.org

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Raj Makkar

310-423-3977 ClinicalTrials@cshs.org

Orange County Heart Institute & Research Center

Recruiting

Orange, California, United States, 92868

Contacts

Brian Kolski

714-564-3300 Jessica.Serna@providence.org

Sutter Bay Hospitals

Recruiting

San Francisco, California, United States, 94107

Contacts

David Daniels

415-600-1051 milena.ferreira@sutterhealth.org

Los Robles Hospital & Medical Center

Recruiting

Thousand Oaks, California, United States, 91360

Contacts

Saibal Kar

805-796-7836 Claire.Hozinsky@hcahealthcare.com

Baptist Medical Center

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Siddharth Wayagankar

904-398-0125 Almer.Mendoza@bmcjax.com

Doran Byers

Doran.Byers@bmcjax.com

NCH Healthcare System

Recruiting

Naples, Florida, United States, 34102

Contacts

Robert Cubeddu

239-624-8113 kathy.byrd@nchmd.org

Sarasota Memorial Health Care System

Recruiting

Sarasota, Florida, United States, 34239

Contacts

Ricardo Yaryura

941-917-2225 ResearchInstitute@smh.com

Wellstar Center for Cardiovascular Care

Recruiting

Atlanta, Georgia, United States, 30060

Contacts

Nabil Sabbak

770-424-6893 research@wellstar.org

Cardiovascular Institute of the South

Recruiting

Houma, Louisiana, United States, 70360

Contacts

Peter Fail, MD

985-876-0300 deanna.benoit@cardio.com

MedStar Health Research Institute, Inc.

Recruiting

Baltimore, Maryland, United States, 21218

Contacts

Brian Bethea

410-554-2332 research@medstar.net

MedStar Health Research Institute, Inc.

Recruiting

Columbia, Maryland, United States, 21044

Contacts

Ron Waksman

202-877-5975 JoinResearch@medstar.net

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Roger Laham

617-667-4443 cto@bidmc.harvard.edu

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Steven Bolling

734-763-6551 ctsogroup@umich.edu

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Brian O'Neil

313-970-6483 hsabbah1@hfhs.org

William Beaumont Hospital

Recruiting

Royal Oak, Michigan, United States, 48073

Contacts

Amr Abbas

248-551-1235 Rachael.Campbell@corewellhealth.org

Minneapolis Heart Institute Foundation

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Vinayak Bapat

877-800-2729 info@mhif.org

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Charanjit Rihal

800-664-4542 clinicaltrials@mayo.edu

Saint Luke's Hospital of Kansas City

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Adnan Chhatriwalla

816-931-1883 ahaley@saint-lukes.org

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Alan Zajarias

314-747-6800 hrpo@wustl.edu

AHS Hospital Corp.

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Phillippe Genereux

973-971-5000 research@atlantichealth.org

New York Presbyterian Hospital-Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Susheel Kodali

(212) 305-7060 sk2427@cumc.columbia.edu

Kate Dalton

(212) 305-7060 keb2114@cumc.columbia.edu

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Mohamed Azeem Latib

718-920-2000 oct@montefiore.org

The Charlotte-Mecklenburg Hospital; Atrium Health

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Michael Rinaldi

800-821-1535 IRBInfo@AtriumHealth.org

East Carolina Heart Institute at East Carolina University

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Paul Mahoney

252-744-4400 research@ecuhealth.org

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Guilherme Attizzani

833-788-7425 MCTU@UHhospitals.org

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Rishi Puri

216-444-6731 lri-contact@ccf.org

South Oklahoma Heart Research, LLC.

Recruiting

Oklahoma City, Oklahoma, United States, 73135

Contacts

Naeem Tahirkheli

405-628-6000 research@okheart.com

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Firas Zahr

503-346-0811 octrirecruitment@ohsu.edu

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Sukhdeep Basra

713-500-3622 clinicaltrials@uth.tmc.edu

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

John Saxon

(434) 924-3606 jgd7s@uvahealth.org

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

James McCabe

206-543-0098 hsdreprt@uw.edu

St. Paul's Hospital

Recruiting

Vancouver, British Colombia, Canada, V6Z 2K5

Contacts

Robert Boone

604-806-8804 Robert.boone@phc.ca

St. Michael's Unity Health Toronto

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Niel Farm

416-864-6060 research@phc.ca

Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Recruiting

Québec, Quebec, Canada, G1V 4G5

Contacts

Josep Rodés Cabau

418-656-8711 Josep.Rodes@criucpq.ulaval.ca

More Information

Sponsor

4C Medical Technologies, Inc.

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

Mitral Regurgitation
TMVR
Functional Regurgitation
Degenerative Regurgitation
Transcatheter Mitral Valve Replacement
Primary Regurgitation
Secondary Regurgitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by 4C Medical Technologies, Inc. on 2026-08-03.