IASD System II Implant for Heart Failure

Recruiting in Palo Alto (17 mi)

+106 other locations

Overseen bySanjiv Shah, MD

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?

Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control group; 1:1 randomization.

Eligibility Criteria

This trial is for adults over 40 with chronic heart failure, who have symptoms like shortness of breath or a history of hospital visits for heart failure. They should have a left ventricular ejection fraction of 40% or higher and be on stable heart failure medication. People can't join if they need dialysis, had recent major heart procedures, or have severe valve disease.

Inclusion Criteria

I have moderate to severe heart failure symptoms or signs in the past year.

I have been hospitalized or treated for heart failure, or my heart failure markers are high.

I have chronic heart failure with symptoms.

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Exclusion Criteria

I have a serious untreated blockage in my neck artery that may need treatment.

I started heart rhythm treatment within the last 6 months.

I have had a heart attack, heart surgery, or a procedure to open my heart's arteries in the last 3-12 months.

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Treatment Details

Interventions

IASD System II implant (Device)
Intra-Cardiac Echocardiography (Other)
Transesophageal Echocardiography (Other)

Trial OverviewThe REDUCE LAP-HF TRIAL II is testing the IASD System II implant against standard care in people with heart failure. Participants are randomly assigned to either get the implant or not in equal numbers, and neither the participants nor the study team will know who got which treatment (blinded).

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention

Patients randomized to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and IASD System II implant procedure.

Group II: ControlPlacebo Group1 Intervention

Patients randomized to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium.