Inter-Atrial Shunt Device for Heart Failure

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

44 Participants Needed

Trial Summary

What is the purpose of this trial?

A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with 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 data supports the effectiveness of the treatment IASD® System II for heart failure?

Research shows that the IASD® System II can help people with heart failure by reducing pressure in the heart, improving symptoms, and enhancing quality of life. Studies have found that it can lower the pressure in the heart's left side and improve exercise capacity, which may lead to fewer hospital visits for heart failure. ^{1 2 3 4 5}

Is the Inter-Atrial Shunt Device safe for humans?

The Inter-Atrial Shunt Device (IASD) has been shown to be safe in patients with heart failure, with studies indicating it is safe compared to a sham treatment at one month of follow-up. However, longer-term safety data is still needed. ^{1 2 3 4 6}

How is the Inter-Atrial Shunt Device (IASD) treatment different from other heart failure treatments?

The Inter-Atrial Shunt Device (IASD) is unique because it reduces pressure in the heart by creating a small passage between the heart's upper chambers, allowing blood to flow from the left to the right side. This approach is different from traditional heart failure treatments, which typically focus on medications or devices that support heart function without altering the heart's structure. ^{1 2 3 4 7}

Research Team

Sanjiv Shah, MD

Principal Investigator

Northwestern University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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 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]

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

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

3. 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]

4. 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]

5. England pubmed.ncbi.nlm.nih.gov

Impact of an interatrial shunt device on survival and heart failure hospitalization in patients with preserved ejection fraction. [2021]

6. 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]

7. Poland pubmed.ncbi.nlm.nih.gov

InterAtrial Shunt Device (IASD®) implantation - a novel treatment method for heart failure with preserved ejection fraction. [2017]