Recruiting

ATLAS (AltaValve) Pivotal Trial

4C Medical Technologies, Inc. · NCT06465745

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation: Not posted. Ask the study team before screening.
Who can join: Ages 18+ · All sexes
Healthy volunteers: Not accepted (a condition is required)
Study type: Interventional · Not applicable
Target enrollment: 450
US sites recruiting: 36
Study start: September 3, 2024
Record last updated: August 3, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: AltaValve System.

Conditions: Mitral Regurgitation; Mitral Insufficiency; Mitral Valve Incompetence; Mitral Valve Regurgitation; Mitral Incompetence

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

Banner University Medical Center
Phoenix, AZ 85006
Site contact: Paul Sorajja · 602-521-3090 · PBC-TREO-CR@arizona.edu
Abrazo Arizona Heart Hospital
Phoenix, AZ 85016
Site contact: Timothy Byrne · 602-952-002 · jessica.byrne@abrazohealth.com
Dignity Health; St. Joseph's Hospital and Medical Center
Phoenix, AZ 85032
Site contact: Hursh Naik · 602-406-1150 · DHRIAZ@DignityHealth.org
TMC Healthcare
Tucson, AZ 85712
Site contact: Thomas Waggoner · 520-420-2136 · clinicalresearch@tmcaz.com
Scripps Health
La Jolla, CA 92037
Site contact: Curtiss Stinis · 858-824-4168 · CRSLeadership@scrippshealth.org
Cedars-Sinai Medical Center
Los Angeles, CA 90048
Site contact: Raj Makkar · 310-423-3977 · ClinicalTrials@cshs.org
Orange County Heart Institute & Research Center
Orange, CA 92868
Site contact: Brian Kolski · 714-564-3300 · Jessica.Serna@providence.org
Sutter Bay Hospitals
San Francisco, CA 94107
Site contact: David Daniels · 415-600-1051 · milena.ferreira@sutterhealth.org
Los Robles Hospital & Medical Center
Thousand Oaks, CA 91360
Site contact: Saibal Kar · 805-796-7836 · Claire.Hozinsky@hcahealthcare.com
Baptist Medical Center
Jacksonville, FL 32207
Site contact: Siddharth Wayagankar · 904-398-0125 · Almer.Mendoza@bmcjax.com
NCH Healthcare System
Naples, FL 34102
Site contact: Robert Cubeddu · 239-624-8113 · kathy.byrd@nchmd.org
Sarasota Memorial Health Care System
Sarasota, FL 34239
Site contact: Ricardo Yaryura · 941-917-2225 · ResearchInstitute@smh.com
Wellstar Center for Cardiovascular Care
Atlanta, GA 30060
Site contact: Nabil Sabbak · 770-424-6893 · research@wellstar.org
Cardiovascular Institute of the South
Houma, LA 70360
Site contact: Peter Fail, MD · 985-876-0300 · deanna.benoit@cardio.com
MedStar Health Research Institute, Inc.
Baltimore, MD 21218
Site contact: Brian Bethea · 410-554-2332 · research@medstar.net
MedStar Health Research Institute, Inc.
Columbia, MD 21044
Site contact: Ron Waksman · 202-877-5975 · JoinResearch@medstar.net
Beth Israel Deaconess Medical Center
Boston, MA 02215
Site contact: Roger Laham · 617-667-4443 · cto@bidmc.harvard.edu
University of Michigan
Ann Arbor, MI 48109
Site contact: Steven Bolling · 734-763-6551 · ctsogroup@umich.edu
Henry Ford Hospital
Detroit, MI 48202
Site contact: Brian O'Neil · 313-970-6483 · hsabbah1@hfhs.org
William Beaumont Hospital
Royal Oak, MI 48073
Site contact: Amr Abbas · 248-551-1235 · Rachael.Campbell@corewellhealth.org
Minneapolis Heart Institute Foundation
Minneapolis, MN 55407
Site contact: Vinayak Bapat · 877-800-2729 · info@mhif.org
Mayo Clinic
Rochester, MN 55905
Site contact: Charanjit Rihal · 800-664-4542 · clinicaltrials@mayo.edu
Saint Luke's Hospital of Kansas City
Kansas City, MO 64111
Site contact: Adnan Chhatriwalla · 816-931-1883 · ahaley@saint-lukes.org
Washington University
St Louis, MO 63110
Site contact: Alan Zajarias · 314-747-6800 · hrpo@wustl.edu
AHS Hospital Corp.
Morristown, NJ 07960
Site contact: Phillippe Genereux · 973-971-5000 · research@atlantichealth.org
New York Presbyterian Hospital-Columbia University Medical Center
New York, NY 10032
Site contact: Susheel Kodali · (212) 305-7060 · sk2427@cumc.columbia.edu
Montefiore Medical Center
The Bronx, NY 10467
Site contact: Mohamed Azeem Latib · 718-920-2000 · oct@montefiore.org
The Charlotte-Mecklenburg Hospital; Atrium Health
Charlotte, NC 28203
Site contact: Michael Rinaldi · 800-821-1535 · IRBInfo@AtriumHealth.org
East Carolina Heart Institute at East Carolina University
Greenville, NC 27834
Site contact: Paul Mahoney · 252-744-4400 · research@ecuhealth.org
University Hospitals Cleveland Medical Center
Cleveland, OH 44106
Site contact: Guilherme Attizzani · 833-788-7425 · MCTU@UHhospitals.org
Cleveland Clinic Foundation
Cleveland, OH 44195
Site contact: Rishi Puri · 216-444-6731 · lri-contact@ccf.org
South Oklahoma Heart Research, LLC.
Oklahoma City, OK 73135
Site contact: Naeem Tahirkheli · 405-628-6000 · research@okheart.com
Oregon Health & Science University
Portland, OR 97239
Site contact: Firas Zahr · 503-346-0811 · octrirecruitment@ohsu.edu
The University of Texas Health Science Center at Houston
Houston, TX 77030
Site contact: Sukhdeep Basra · 713-500-3622 · clinicaltrials@uth.tmc.edu
University of Virginia
Charlottesville, VA 22903
Site contact: John Saxon · (434) 924-3606 · jgd7s@uvahealth.org
University of Washington
Seattle, WA 98195
Site contact: James McCabe · 206-543-0098 · hsdreprt@uw.edu