| NCT ID | NCT05685303 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alleviant Medical, Inc. |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 700 participants |
| Start Date | 2023-01-10 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 700 participants in total. It began in 2023-01-10 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF/HFmrEF.
Eligibility Criteria
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
Contact & Investigator
James Udelson, MD
PRINCIPAL INVESTIGATOR
Tufts Medical Center
Frequently Asked Questions
Who can join the NCT05685303 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05685303 currently recruiting?
Yes, NCT05685303 is actively recruiting participants. Contact the research team at jen.olson@alleviantmedical.com for enrollment information.
Where is the NCT05685303 trial being conducted?
This trial is being conducted at Phoenix, United States, Scottsdale, United States, Tucson, United States, Long Beach, United States and 11 additional locations.
Who is sponsoring the NCT05685303 clinical trial?
NCT05685303 is sponsored by Alleviant Medical, Inc.. The principal investigator is James Udelson, MD at Tufts Medical Center. The trial plans to enroll 700 participants.
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