750 Participants Needed

Atrial Shunt Device for Heart Failure

Recruiting at 66 trial locations
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Overseen BySanjeeb Bhattacharya, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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).12345

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.12345

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.12345

Research Team

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Martin Leon, MD

Principal Investigator

Columbia University

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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.
See 6 more

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.
See 12 more

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 OverviewThis 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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 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: ControlPlacebo Group1 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.

Find a Clinic Near You

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.
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.
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.
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]

References

Feasibility and efficacy of transcatheter interatrial shunt devices for chronic heart failure: a systematic review and meta-analysis. [2022]
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]
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]
Effects of Interatrial Shunt on Pulmonary Vascular Function in Heart Failure With Preserved Ejection Fraction. [2020]
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]