IASD Implant for Heart Failure
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Corvia Medical
No Placebo Group
Trial Summary
What is the purpose of this trial?
The objective of this pilot study is to evaluate the safety and performance of implanting the IASD® System II in Heart Failure patients with reduced ejection fraction and elevated left sided filling pressures, who remain symptomatic despite Guideline Directed Medical Therapy (GDMT).
Research Team
JK
Jan Komtebedde, DVM
Principal Investigator
Corvia Medical
Eligibility Criteria
Adults over 18 with chronic heart failure, NYHA Class III/IV symptoms, and a history of hospitalization for heart failure. They must have reduced heart function (20-40% ejection fraction) and elevated left atrial pressure despite stable medication treatment. Excluded are those with recent cardiac procedures or devices, uncontrolled arrhythmias or blood pressure, severe lung disease, allergies to nickel, potential childbearing women without contraception use, significant liver impairment or life expectancy less than a year due to other diseases.Inclusion Criteria
Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams
I was hospitalized or visited the ER for heart failure and received IV treatment in the last year.
A procedure to reach my heart through a vein in my leg is possible.
See 6 more
Exclusion Criteria
Your NT-Pro BNP or BNP levels are within certain ranges depending on your heart rhythm.
My heart's right side is not working properly.
I have severe heart issues and cannot walk far without getting tired.
See 22 more
Treatment Details
Interventions
- IASD implant (Device)
Trial OverviewThe trial is testing the safety and effectiveness of an IASD implant in patients with symptomatic heart failure who still have high left-sided heart pressures despite being on standard medications. The device aims to balance the pressures between the left and right sides of the heart.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
IASD Implantation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Corvia Medical
Lead Sponsor
Trials
8
Recruited
2,000+