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Clinical Trials in Spain / NCT05685303
Recruiting Not applicable

Alleviant ALLAY-HF Study

NCT05685303 · tracked via the Priya Life Science Spain tracker
Sponsor
Alleviant Medical, Inc
Phase
Not applicable
Started
2023-01-10
Last updated
2026-08-14

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

Alleviant ALV1 SystemSham-Control

Alleviant ALV1 System: Creation of interatrial shunt

Sham-Control: Cardiac imaging

Study 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

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Composite Primary Endpoint — 12-month
    The primary endpoint is a composite of mortality, heart failure events and quality of life based on Kansas City Cardiomyopathy Questionnaire (KCCQ) calculated at 12 months. KCCQ responses are provided along a rating scale from 0-100 with a higher score indicating better health.

Trial sites (93)

FacilityCityRegionStatus
Arizona Cardiovascular Research Center Phoenix Arizona Active Not Recruiting
HonorHealth Scottsdale Arizona Terminated
Pima Heart and Vascular Tucson Arizona Recruiting
Memorial Care Long Beach Medical Center Long Beach California Recruiting
UC Davis Medical Center Sacramento California Recruiting
Scripps Clinical Research Services San Diego California Recruiting
University of California San Francisco San Francisco California Recruiting
Santa Barbara Cottage Hospital Santa Barbara California Recruiting
Hartford Hospital Hartford Connecticut Terminated
The Cardiac and Vascular Institute (TCAVI) Gainesville Florida Recruiting
HCA Florida Memorial Hospital Jacksonville Florida Recruiting
NCH Research Institute Naples Florida Recruiting
Advent Health Orlando Orlando Florida Recruiting
Ascension Sacred Heart Pensacola Florida Recruiting
Atlanta VA Health Care System Decatur Georgia Recruiting
Advocate Illinois Masonic Medical Center Chicago Illinois Terminated
Midwest Cardiovascular Institute Naperville Illinois Recruiting
Prairie Education and Research Cooperative Springfield Illinois Active Not Recruiting
Indiana University Indianapolis Indiana Recruiting
St. Elizabeth Healthcare Edgewood Kentucky Recruiting
Cardiovascular Institute of the South Houma Louisiana Recruiting
University Medical Center New Orleans New Orleans Louisiana Recruiting
Johns Hopkins Medical Institution Baltimore Maryland Recruiting
Brigham and Women's Hospital Boston Massachusetts Recruiting
Boston Medical Center Boston Massachusetts Recruiting
Steward St. Elizabeth's Medical Center Brighton Massachusetts Terminated
VA Ann Arbor Ann Arbor Michigan Recruiting
Ascension St. John Hospital Detroit Michigan Terminated
Minneapolis Heart Institute Foundation Minneapolis Minnesota Recruiting
Washington University - St Louis St Louis Missouri Recruiting
UMC of Southern Nevada Las Vegas Nevada Recruiting
VA NY Harbor Healthcare System New York New York Terminated
New York University New York New York Recruiting
Lenox Hill Hospital New York New York Active Not Recruiting
St. Francis Hospital Roslyn New York Terminated
Stony Brook Medicine Stony Brook New York Recruiting
Mission Hospital Asheville North Carolina Recruiting
Duke University Hospital Durham North Carolina Recruiting
NC Heart and Vascular Research Raleigh North Carolina Recruiting
Cleveland Clinic Cleveland Ohio Recruiting

+ 53 more sites — see the full list on the official registry below.

More Alleviant Medical, Inc. trials in Spain

Alleviant ALLAY-HFrEF Study Recruiting

Other trials for the same condition

Personalized Therapy Study - HFRS (TriageHF) Post Approval Study Active, not recruiting
Personalized Therapy Study - Attain Stability Quad Post-Approval Study Active, not recruiting
Effect of Acetazolamide on Diuresis and Natriuresis in Patients With Acute Heart Failure (SANDI STUDY) Recruiting
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin Recruiting
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05685303 on ClinicalTrials.gov ↗ ← All trials in Spain