Inter-Atrial Shunt Device for Heart Failure

Not currently recruiting at 21 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Corvia Medical

Disqualifiers: Severe heart failure, Stroke, DVT, others

Compensation: Varies

Number of Visits: 1

Duration: 1 month

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, to determine if it can help people with heart failure by reducing heart pressure. The goal is to see if this device can relieve symptoms and improve life for those with ongoing heart problems. Participants will either receive the device or undergo a procedure without it, with an option to switch later. Ideal candidates for the trial are those experiencing heart failure symptoms and a specific heart pressure issue but have not had a recent heart attack or severe heart event. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for heart failure.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It mentions ongoing stable management of heart failure and other conditions, so you might be able to continue your current treatment.

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

Research has shown that the inter-atrial shunt device (IASD) is generally safe for people with heart failure. In one study, the long-term risk of death for patients using the device was about 1.9%, indicating it is a relatively safe option. Another study found that patients with heart failure who used the device experienced a 44% reduction in heart failure-related incidents.

Overall, these findings suggest that the IASD is well-tolerated. Many patients have reported improvements in their quality of life after using the device. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for heart failure, which often rely on medications or invasive surgeries, the IASD® System II introduces a novel approach by implanting a small device to create a controlled passageway between the heart's atria. This unique mechanism helps reduce pressure in the left atrium, potentially easing the symptoms of heart failure. Researchers are excited about this treatment because it offers a less invasive option with the potential for immediate pressure relief, which could significantly improve patients' quality of life.

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

Research on the IASD System II for heart failure patients has shown mixed results. In this trial, participants may receive the IASD implant through randomization. One study found that the device did not improve heart health or patient function more than a placebo procedure. However, another study showed a 44% decrease in heart failure events and improved quality of life for some patients using the device. The device is also considered safe, with a low long-term death rate of 1.9% in heart failure patients. These findings suggest the device might help some patients, but not everyone. ^{1 2 4 5 6}

Who Is on the Research Team?

Sanjiv Shah, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the IASD implant or undergo intracardiac echo if in the control group

1 month

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of MACCRE and PCWP

1 month

Multiple visits (in-person) for PCWP measurements

Extension

Control group participants have the option to crossover to receive the IASD implant at 1 year

What Are the Treatments Tested in This Trial?

Interventions

• IASD® System II
• Intracardiac Echo

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

The REDUCE LAP HF-II trial will assess the clinical efficacy of the InterAtrial Shunt Device (IASD) in patients with heart failure and elevated left atrial pressure, involving up to 608 participants aged 40 and older with specific heart function criteria.

The primary endpoint includes a composite of cardiovascular outcomes and symptom improvement over 12 to 24 months, with follow-up extending to 5 years to evaluate long-term effects of the IASD on heart function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter InterAtrial Shunt Device for the treatment of heart failure: Rationale and design of the pivotal randomized trial to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure II (REDUCE LAP-HF II). Berry, N., Mauri, L., Feldman, T., et al.[2020]

In a randomized sham-controlled trial involving 94 patients with heart failure and an ejection fraction of 40% or higher, the transcatheter interatrial shunt device (IASD) significantly reduced pulmonary capillary wedge pressure (PCWP) during exercise compared to a sham procedure, indicating its potential efficacy in managing heart failure symptoms.

The IASD showed a favorable safety profile, with no major adverse cardiac, cerebrovascular, or renal events reported in the treatment group within one month, suggesting it is a safe intervention for patients with heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure With Preserved Ejection Fraction (REDUCE LAP-HF I [Reduce Elevated Left Atrial Pressure in Patients With Heart Failure]): A Phase 2, Randomized, Sham-Controlled Trial. Feldman, T., Mauri, L., Kahwash, R., et al.[2019]

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]

Citations

1. acc.org acc.org/Latest-in-Cardiology/Clinical-Trials/2022/02/22/19/56/REDUCE-LAP-HF-II

A Study to Evaluate the Corvia Medical, Inc. IASD System II ... The use of the Corvia IASD System II was not superior to a sham procedure in improving cardiovascular events or functional status among patients ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12576559/

Efficacy and safety of interatrial shunt treatment for heart ... Interatrial shunt devices (IASDs), which allow blood flow from the left to the right atrium, offer a novel treatment approach by reducing left ...

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38630494/

The REDUCE LAP-HF II Randomized Clinical Trial - PubMed This was a sham-controlled randomized clinical trial of an atrial shunt device in heart failure with preserved ejection fraction (HFpEF)/HF with mildly reduced ...

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

One-Year Safety and Clinical Outcomes of a Transcatheter ... In patients with heart failure and ejection fraction equal to or greater than 40%, is an interatrial shunt device (IASD) safe compared with a sham control ...