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Recruiting NCT06465745

ATLAS (AltaValve) Pivotal Trial

No phase Interventional Mitral Regurgitation Mitral Insufficiency Mitral Valve Incompetence Mitral Valve Regurgitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AltaValve System..
Who it may be relevant to
Registry conditions: Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence, Mitral Valve Regurgitation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada, France, Germany, Greece +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

ATLAS (A Transseptal Left Atrial System for Treatment of Mitral Regurgitation) Pivotal Trial

Overview

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.

Interventions

  • Device AltaValve System.
    Transcatheter Mitral Valve Replacement.

Primary outcome measures

  • Composite of all-cause mortality or heart failure hospitalization. [Time frame: 12 months.]
Secondary outcome measures (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. [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.]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 36 centers
  • Banner University Medical Center — Phoenix
  • Abrazo Arizona Heart Hospital — Phoenix
  • Dignity Health; St. Joseph's Hospital and Medical Center — Phoenix
  • TMC Healthcare — Tucson
  • Scripps Health — La Jolla
  • Cedars-Sinai Medical Center — Los Angeles
  • Orange County Heart Institute & Research Center — Orange
  • Sutter Bay Hospitals — San Francisco
  • … and 28 more centers
Germany · 8 centers
  • Charité - Universitätsmedizin Berlin — Berlin
  • Universitatsklinikum Bonn — Bonn
  • University Hospital Cologne - Heart Center — Cologne
  • Cardiac Research GmbH; St.-Johannes-Hospital Dortmund — Dortmund
  • Universitätsmedizin der Johannes Gutenberg Universität Mainz — Mainz
  • University Hospital of the Ruhr University Bochum — Oeynhausen
  • Heart Center Trier — Trier
  • Universitiitsklinikum Ulm — Ulm
France · 4 centers
  • Centre Hospitalier Universitaire de Bordeaux — Bordeaux
  • L'Assistance Publique-Hôpitaux de Marseille (AP-HM) — Marseille
  • Société d'Exploitation du Centre Cardiologique du Nord — Paris
  • Clinique Pasteur — Toulouse
Canada · 3 centers
  • St. Paul's Hospital — Vancouver
  • St. Michael's Unity Health Toronto — Toronto
  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec — Québec
Greece · 3 centers
  • Onassis Cardiac Surgery Center — Athens
  • Univeristy Hospital of Ioannina — Ioannina
  • Interbalkan Medical Center of Thessaloniki — Thessaloniki
Spain · 3 centers
  • Hospital Clinic de Barcelona — Barcelona
  • Fundación para la investigación biomédica del hospital clínico San Carlos — Madrid
  • Hospital Álvaro Cunqueiro — Vigo
Poland · 1 center
  • Uniwersyteckim Szpitalem Klinicznym — Poznan

Identifiers

NCT: NCT06465745 · 5472

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗