ATLAS (AltaValve) Pivotal Trial

Conditions

• Mitral Incompetence
• Mitral Insufficiency
• Mitral Regurgitation
• Mitral Valve Incompetence
• Mitral Valve Regurgitation

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• AltaValve System. — DEVICE
  Transcatheter Mitral Valve Replacement.

Study Details

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.

Key Dates

First listed

Jun 20, 2024

Start date

Sep 3, 2024

Status verified

Jul 2026

Primary completion

Sep 30, 2029

Completion

Sep 30, 2031

Study Design

Enrollment

450 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Locations (36)

Find similar trials in Phoenix, AZ

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