Atrial Shunt Device for Heart Failure

Recruiting at 66 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

Trial Summary

What is the purpose of this trial?

Multicenter, Prospective, Randomized, Sham Controlled, Double Blinded Clinical Trial, with; 1:1 randomization

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 data supports the effectiveness of the treatment Corvia Atrial Shunt System / IASD System II for heart failure?

Research shows that the Corvia Atrial Shunt System can lower pressure in the heart and improve symptoms and quality of life for people with heart failure, especially those with a certain type of heart function (ejection fraction of 40% or more). ^{1 2 3 4 5}

Is the Atrial Shunt Device safe for humans?

The Atrial Shunt Device has been shown to be safe in humans for up to one month in a clinical trial for heart failure, but longer-term safety data is not yet available. ^{1 2 3 4 5}

How is the Corvia Atrial Shunt System different from other heart failure treatments?

The Corvia Atrial Shunt System is unique because it is a device implanted through a catheter that creates a small opening between the heart's upper chambers, helping to reduce pressure in the left atrium and improve symptoms in heart failure patients with preserved ejection fraction. This approach is different from traditional heart failure treatments, which often involve medications or lifestyle changes. ^{1 2 3 4 5}

Research Team

Martin Leon, MD

Principal Investigator

Columbia University

Sanjiv Shah, MD

Principal Investigator

Northwestern Memorial Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Feasibility and efficacy of transcatheter interatrial shunt devices for chronic heart failure: a systematic review and meta-analysis. [2022]

2. United States 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. [2019]

3. United States 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of Interatrial Shunt on Pulmonary Vascular Function in Heart Failure With Preserved Ejection Fraction. [2020]

5. United States 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). [2020]