Inter-Atrial Shunt Device for Heart Failure

Recruiting in Palo Alto (17 mi)

+21 other locations

Overseen by Sanjiv Shah, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Corvia Medical

Trial Summary

What is the purpose of this trial?

A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure.

Research Team

Sanjiv Shah, MD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for adults over 40 with chronic heart failure who have a left ventricular ejection fraction of at least 40% and elevated left atrial pressure. They must be on stable heart failure medication, able to do some exercise but not too much (can walk between 50m and 600m in six minutes), and their kidneys must work well enough (estimated-GFR ≥25ml/min/1.73 m2). People with severe heart failure, recent heart attacks or surgeries, significant untreated artery blockages, serious valve disease, or recent strokes aren't eligible.

Inclusion Criteria

I am 40 years old or older.

I have ongoing heart failure symptoms.

Your heart's pumping ability is at least 40%, and it has not been less than 30% in the past.

Exclusion Criteria

I am on dialysis or my kidney function is very low.

I have had a heart attack or heart surgery in the last 3 months.

I started heart rhythm treatment within the last 6 months.

Treatment Details

Interventions

• IASD® System II (Inter-Atrial Shunt Device)
• Intracardiac Echo (Other)

Trial Overview The study tests the IASD System II device designed by Corvia Medical to lower high pressure in the left atrium of the heart in patients with Heart Failure. It also uses Intracardiac Echo as part of the procedure to help doctors see inside the heart better during treatment.

Participant Groups

Group I: Treatment with Inter-Atrial Shunt Device Experimental Treatment 1 Intervention

Once all study criteria have been met, if randomized to this arm, patients will receive the IASD implant.

Group II: Control Placebo Group 1 Intervention

Once all study criteria have been met, if randomized to this arm, patients will not receive the implant. They will undergo an intracardiac echo only, with the option to crossover at 1 year.

Who Is Running the Clinical Trial?

Corvia Medical

Lead Sponsor

Trials

8

Recruited

2,000+