NCT06465745RecruitingNot Applicable
ATLAS (A Transseptal Left Atrial System for Treatment of Mitral Regurgitation) Pivotal Trial
4C Medical Technologies, Inc.58 sites in 6 countries450 target enrollmentStarted: September 3, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 450
- Locations
- 58
- Primary Endpoint
- Composite of all-cause mortality or heart failure hospitalization.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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).
Intervention: AltaValve System. (Device)
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.
Intervention: AltaValve System. (Device)
Outcomes
Primary Outcomes
Composite of all-cause mortality or heart failure hospitalization.
Time Frame: 12 months.
Secondary Outcomes
- New pacemaker rate.(1 month, 6 months and 1 year.)
- Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ).(6 months and 1 year.)
- 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.(30 Days or hospital discharge (whichever is longer).)
- Technical success.(Day 0.)
- Mitral valve re-intervention.(At 30 days, 6 months, 1 year, and annually thereafter for up to 5 years.)
- Changes in Six-minute walk test (6MWT).(6 months and 1 year.)
Investigators
Study Sites (58)
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