Heart Failure study: Alleviant ALV1 System
Official title Alleviant ALLAY-HF Study
ClinicalTrials.gov ID: NCT05685303
What this study is testing
- What it's testing
- The study wants to see if the device is safe and if it helps people with HFpEF or HFmrEF.
- Who it's for
- Adults who have heart failure with preserved or mildly reduced ejection fraction.
- What's involved
- Participants will have a small device placed in the heart through a catheter, then follow up visits and tests to monitor safety and effectiveness.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
- NYHA Class II, III or ambulatory IV
- Exercise right heart catheterization\
- Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)
- Exercise PVR \< 1.8 WU
You likely can't join if
- Advanced heart failure
- Presence of a pacemaker
- Evidence of right heart dysfunction
See the full eligibility criteria
- Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
- NYHA Class II, III or ambulatory IV
- Exercise right heart catheterization\
- Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)
- Exercise PVR \< 1.8 WU
- Ongoing stable GDMT
- Advanced heart failure
- Presence of a pacemaker
- Evidence of right heart dysfunction
The study team makes the final eligibility decision.
Where it is enrolling
- Tucson, Arizona, United States
- Long Beach, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Santa Barbara, California, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Naples, Florida, United States
- Orlando, Florida, United States
- Pensacola, Florida, United States
- Decatur, Georgia, United States
- Naperville, Illinois, United States
- Indianapolis, Indiana, United States
- Edgewood, Kentucky, United States
- Houma, Louisiana, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
+ 49 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Tucson, Arizona, United States; Long Beach, California, United States; Sacramento, California, United States; San Diego, California, United States; San Francisco, California, United States; Santa Barbara, California, United States and 63 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.