Interatrial shunt with Alleviant ALV1 for heart failure with preserved or mid-range ejection fraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, randomized, sham-controlled, double-blinded, adaptive study evaluating the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with heart failure with preserved or mid-range ejection fraction. Participants must have symptomatic HFpEF/HFmrEF, LVEF ≥40%, NYHA class II–IV, and evidence of elevated left atrial pressure during exercise, among other criteria, and must be on stable guideline-directed medical therapy. The intervention involves the Alleviant ALV1 System versus a sham-control, with outcomes assessed through safety and efficacy measures. The trial is conducted at multiple centers in Arizona with lead sponsor Alleviant Medical, Inc. No collaborators are listed.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
2. NYHA Class II, III or ambulatory IV
3. Exercise right heart catheterization\*

   1. Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)
   2. Exercise PVR \< 1.8 WU
4. Ongoing stable GDMT

Exclusion Criteria:

1. Advanced heart failure
2. Presence of a pacemaker
3. Evidence of right heart dysfunction

Where it's running

• Pima Heart and Vascular
  Tucson, Arizona, United States Recruiting
• Memorial Care Long Beach Medical Center
  Long Beach, California, United States Recruiting
• UC Davis Medical Center
  Sacramento, California, United States Recruiting
• Scripps Clinical Research Services
  San Diego, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• Santa Barbara Cottage Hospital
  Santa Barbara, California, United States Recruiting

+43 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: James Udelson, MD — Tufts Medical Center
• Study coordinator: Jennifer Olson
• Email: jen.olson@alleviantmedical.com
• Phone: +1 612 327 2741

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.