IASD System II Implant for Heart Failure

Not currently recruiting at 113 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Corvia Medical

Must be taking: Diuretics

Disqualifiers: Recent MI, Advanced heart failure, Stroke, Significant valve disease, Dialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the IASD System II implant, designed to assist people with heart failure, a condition where the heart struggles to pump blood effectively. The goal is to determine if the implant improves symptoms more effectively than a control procedure without the implant. Participants will receive either the implant or a similar procedure without it to compare results. Ideal candidates experience heart failure symptoms such as shortness of breath or swollen legs and are already on heart failure medication. As an unphased trial, this study allows patients to contribute to innovative heart failure treatment research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires that your heart failure management remains stable without significant changes for at least 6 months, except for diuretic dose adjustments.

What prior data suggests that the IASD System II implant is safe for heart failure patients?

Studies have shown that the IASD System II implant is a relatively safe option for people with heart failure. One study found that patients with a heart condition and a heart pumping ability of 40% or more handled the implant well over a year. Another study reported a long-term death rate of only about 1.9% among these patients, suggesting the implant's safety. Additionally, the implant has provided benefits such as fewer heart failure incidents and improved quality of life for responsive patients. Overall, research indicates that the IASD System II implant is well-tolerated, with few serious side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

The IASD System II implant is unique because it offers a novel approach to treating heart failure by directly targeting the heart's structure. Unlike traditional treatments that typically focus on managing symptoms through medication or lifestyle changes, this implant involves a minimally invasive procedure to create a small opening in the atrial septum. This technique helps to reduce pressure buildup in the left atrium, potentially improving heart function and reducing symptoms. Researchers are excited about this treatment because it addresses the underlying mechanical issues of heart failure, offering a new avenue for improving patient outcomes.

What evidence suggests that the IASD System II implant is effective for heart failure?

Research has shown that the IASD System II implant, which participants in this trial may receive, can help people with heart failure. In earlier studies, patients with this implant experienced 44% fewer heart failure incidents, resulting in fewer hospital visits and improved quality of life. The implant lowers pressure in the left atrium, enhancing heart function. Studies also indicate it is safe, with a low long-term death rate of 1.9%. These findings suggest that this implant could be a useful option for managing heart failure. ^{1 2 4 5 6}

Who Is on the Research Team?

Sanjiv Shah, MD

Principal Investigator

Northwestern Memorial Hospital

Marty Leon, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Randomization and Procedure

Eligible patients are randomized to treatment or control group; treatment group undergoes IASD System II implant procedure, control group undergoes examination

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, with evaluations at pre-specified intervals

24 months

Multiple visits (in-person and virtual)

Long-term Follow-up

Participants are followed for long-term outcomes and safety for up to 5 years

5 years

What Are the Treatments Tested in This Trial?

Interventions

• IASD System II implant
• Intra-Cardiac Echocardiography
• Transesophageal Echocardiography

Trial Overview The 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).

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 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: Control Placebo Group 1 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.

Who Is Running the Clinical Trial?

Corvia Medical

Lead Sponsor

Trials

8

Recruited

2,000+

Published Research Related to This Trial

The transcatheter interatrial shunt device (IASD) demonstrated long-term safety and maintained patency over one year in patients with heart failure, showing no significant difference in major adverse cardiac events compared to a sham control.

Patients treated with the IASD had a lower rate of hospitalizations for heart failure (0.22 per year) compared to the control group (0.63 per year), suggesting potential clinical benefits, although the difference was not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-Year Safety and Clinical Outcomes of a Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure With Preserved Ejection Fraction in the Reduce Elevated Left Atrial Pressure in Patients With Heart Failure (REDUCE LAP-HF I) Trial: A Randomized Clinical Trial. Shah, SJ., Feldman, T., Ricciardi, MJ., et al.[2023]

The implantation of an interatrial shunt device (IASD) in 79 heart failure patients significantly improved pulmonary vascular function, evidenced by a 17% reduction in pulmonary vascular resistance and a 24% increase in pulmonary artery compliance, without compromising systemic blood flow.

Following IASD, there was a notable increase in pulmonary blood flow and oxygen content, with patients experiencing enhanced exercise capacity, particularly those who showed greater improvements in pulmonary artery compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Interatrial Shunt on Pulmonary Vascular Function in Heart Failure With Preserved Ejection Fraction. Obokata, M., Reddy, YNV., Shah, SJ., et al.[2020]

Interatrial shunt devices (IASD) are feasible for treating chronic heart failure (CHF) and significantly improve exercise capacity, with a 28.1 m increase in 6-minute walking distance (6MWD) after 12 months in 226 patients across six studies.

Patients also experienced a notable improvement in health-related quality of life (HRQoL) by 17.7 points and a reduction in pulmonary capillary wedge pressure (PCWP) by 2.0 mmHg, with a low risk of serious adverse effects at 8% over the same period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and efficacy of transcatheter interatrial shunt devices for chronic heart failure: a systematic review and meta-analysis. Lauder, L., Pereira, TV., Degenhardt, MC., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6233816/

One-Year Safety and Clinical Outcomes of a Transcatheter ... Through 1 year of follow-up, IASD treatment appears to be safe in patients with heart failure and ejection fraction equal to or greater than 40%. This ...

2. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2817472

Atrial Shunt Device Effects on Cardiac Structure and ... This post hoc analysis of A Study to Evaluate the Corvia Medical Inc IASD System II to Reduce Elevated Left Atrial Pressure in Patients With ...

3. corviamedical.com corviamedical.com/corvia-medical-announces-three-year-clinical-trial-results-confirming-significant-and-durable-benefits-of-the-corvia-atrial-shunt-in-heart-failure-patients/

Corvia Medical Announces Three-Year Clinical Trial ... 44% reduction in total heart failure event rate and ongoing improvements in quality of life in responder group patients implanted with shunt.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02600234

NCT02600234 | REDUCE LAP-HF RANDOMIZED TRIAL I A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure. Detailed Description. The ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0146280625001021

Safety and effectiveness after atrial shunt device in patients ... The long-term estimated pooled mortality of ASD in heart failure patients was 1.9% (95% CI: 0.1% to 3.8%), indicating it is a relatively safe option.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30167646/

One-Year Safety and Clinical Outcomes of a Transcatheter ... The REDUCE LAP-HF I phase 2, sham-controlled RCT confirms the longer-term patency of the IASD. Through 1 year of follow-up, IASD treatment appears safe.