Atrial Shunt Device for Heart Failure

Recruiting at 69 trial locations

Overseen By Sanjeeb Bhattacharya, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Corvia Medical

Must be taking: Diuretics

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Advanced heart failure, Right ventricular dysfunction, Implanted cardiac device, Severe depression, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 24 months

750 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment, the Corvia Atrial Shunt System, for individuals with heart failure. The researchers aim to determine if this device can improve symptoms by enhancing the heart's ability to pump blood efficiently. Participants will receive either the experimental treatment or a comparison procedure without the device. This trial suits individuals who regularly manage heart failure symptoms with diuretics (medications that help remove excess fluid) and have experienced hospital visits for heart failure in the past year. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could lead to innovative heart failure treatments.

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 mentions that participants should be on stable heart failure treatment according to guidelines, which suggests you may continue your current medications if they are part of this treatment.

What prior data suggests that the Corvia Atrial Shunt System / IASD System II is safe for heart failure patients?

Research has shown that the Corvia Atrial Shunt System, also known as the IASD System II, is generally well-tolerated by patients with heart failure. In one study, patients who responded well to the shunt experienced a 44% reduction in heart failure events, indicating effectiveness for some individuals. Clinical results have consistently demonstrated the device's safety. One study confirmed its safety by comparing it to a sham control, where some patients received a fake treatment. The device did not cause more safety issues than the fake treatment. Although the device didn't improve all outcomes for certain heart failure patients, its safety record remains reassuring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Corvia Atrial Shunt System is unique because it offers a new approach to managing heart failure by creating a controlled atrial septal opening to reduce pressure in the left atrium, potentially improving symptoms and quality of life. Unlike standard treatments like medications (e.g., ACE inhibitors, beta-blockers) or invasive procedures (e.g., pacemakers, ventricular assist devices), this device provides a minimally invasive way to address the underlying hemodynamic imbalance. Researchers are excited about this treatment because it targets the root cause of elevated atrial pressure, offering hope for better management of heart failure symptoms with a less invasive procedure than traditional surgical options.

What evidence suggests that the Corvia Atrial Shunt Device is effective for heart failure?

Research has shown that the Corvia Atrial Shunt System might reduce heart failure events by 44% in some patients, who also reported feeling better over three years. However, other studies found no significant difference between the shunt and a sham procedure in improving heart failure. In this trial, participants will be randomized into two groups: one will receive the Corvia Atrial Shunt System, and the other will undergo a sham procedure for comparison. While some patients benefit, results vary among individuals with heart failure. The shunt is considered safe. Those considering this treatment should note that it might help some people more than others. ^{1 2 3 5 6}

Who Is on the Research Team?

Sanjiv Shah, MD

Principal Investigator

Northwestern Memorial Hospital

Martin Leon, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

The RESPONDER-HF Trial is for adults over 40 with chronic heart failure who are experiencing symptoms despite current treatment. They must have a history of hospitalization or elevated NT-pro BNP levels, be in NYHA class II-IV, and have stable heart function and management. Participants need to agree to follow-up visits and provide consent. Exclusions include recent cardiac events, other significant health issues, women who can become pregnant, severe mental health conditions, participation in conflicting studies, certain implanted devices or structural heart repairs.

Inclusion Criteria

I understand the study details and have signed the consent form.

Participant is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams

I have chronic heart failure and need diuretics, with symptoms that affect my daily activities.

Exclusion Criteria

My condition is advanced heart failure.

I am experiencing severe depression or anxiety.

Your right ventricle is not functioning properly based on specific criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either the Corvia Atrial Shunt implant procedure or a sham procedure with echocardiography

Up to 24 months

Regular visits at pre-specified intervals

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of heart failure events and other cardiovascular outcomes

5 years

Annual visits

Unblinding

All patients will be unblinded after the 24-month follow-up visit

What Are the Treatments Tested in This Trial?

Interventions

• Corvia Atrial Shunt System / IASD System II

Trial Overview This trial tests the Corvia Atrial Shunt System against a sham procedure (a fake operation that seems real) to see if it helps people with heart failure feel better or stay out of the hospital. It's randomized (people are put into groups by chance), double-blinded (neither doctors nor patients know who gets the real treatment), and includes echocardiography checks using ICE or TEE methods.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

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

Group II: Control Placebo Group 1 Intervention

Participants randomized to the control arm will undergo fluoroscopy and intracardiac echocardiography from the femoral vein or transesophageal echocardiography, for examination of the atrial septum and left atrial appendage.

Who Is Running the Clinical Trial?

Corvia Medical

Lead Sponsor

Trials

8

Recruited

2,000+

Published Research Related to This Trial

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 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]

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]

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]

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. 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.

2. 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 ...

3. 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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2213177924003317

2-Year Outcomes of an Atrial Shunt Device in HFpEF ... The Corvia Atrial Shunt did not improve outcomes in heart failure with preserved or mildly reduced ejection fraction.

5. corviamedical.com corviamedical.com/healthcare-professionals/clinical-evidence/

Clinical Evidence - Corvia® Atrial Shunt Clinical results have consistently established the safety of the Corvia Atrial Shunt System and have demonstrated encouraging efficacy in heart failure patients ...

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 ...