The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).

Conditions

• Mitral Annular Calcification
• Mitral Regurgitation
• Mitral Stenosis
• Mitral Valve Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Transseptal ViMAC — DEVICE
  Transseptal TMVR using balloon-expandable aortic transcatheter valves.

Study Details

A prospective multicenter study enrolling high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve dysfunction (severe stenosis, ≥ moderate to severe regurgitation, or mixed ≥ moderate stenosis and ≥ regurgitation). There are 2 Arms in this study: 1) "Transseptal (TS) Valve-in-MAC" (ViMAC) Arm, and 2) Natural History of Disease Registry (NHDR) for patients treated with medical treatment only (which includes patients who meet inclusion criteria but can't be treated with transeptal ViMAC due to the presence of anatomical exclusion criteria or other exclusion criteria) and have not had other procedures that may impact outcomes (i.e., alcohol septal ablation or radiofrequency ablation). The study also includes a Registry of Permanently Unassigned" for subjects who undergo preemptive septal ablation procedures (alcohol or radiofrequency) in anticipation of continuing onto ViMAC arm, but are not accepted in the ViMAC Study arm or the patient chooses not to undergo ViMAC procedure.

Key Dates

Start date

Mar 8, 2021

Status verified

Jan 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2030

Study Design

Enrollment

210 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Transseptal ViMAC
  110 MAC patients treated with transseptal Valve-in-MAC.
• No Intervention: Registry of untreated patients
  100 MAC patients not eligible for transseptal ViMAC, treated with conservative management including medications.

Primary Outcome Measure

Primary Safety Endpoint: All Cause Morality and Hospitalization for Heart Failure [ Time Frame: 1 year. ]

Central Contacts

• Tatiana Kaptzan, Ph. D.
  507-284-1610
  [email protected]

Locations (16)

Find similar trials in Gilbert, AZ

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