IASD Implant for Heart Failure

Recruiting at 5 trial locations

Overseen By Jan Komtebedde, DVM

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Corvia Medical

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

Compensation: Varies

Number of Visits: Unknown

Duration: Index Procedure

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this pilot study is to evaluate the safety and performance of implanting the IASD® System II in Heart Failure patients with reduced ejection fraction and elevated left sided filling pressures, who remain symptomatic despite Guideline Directed Medical Therapy (GDMT).

Will I have to stop taking my current medications?

The trial requires participants to stay on their current heart failure medications without significant changes for at least 6 months. So, you should not stop taking your current medications if you join this trial.

Is the IASD implant generally safe for humans?

The IASD implant has been shown to be generally safe in humans, with rare complications during the procedure and good midterm safety in studies. However, longer-term safety data is still needed. ^{1 2 3 4 5}

How does the IASD implant treatment for heart failure differ from other treatments?

The IASD implant is unique because it is a device specifically designed to treat heart failure by creating a controlled opening between the left and right atria of the heart, which can help reduce pressure and improve symptoms. This approach is different from other treatments like ventricular assist devices (VADs) or implantable cardioverter defibrillators (ICDs), which focus on supporting heart function or preventing dangerous heart rhythms. ^{6 7 8 9 10}

Research Team

Jan Komtebedde, DVM

Principal Investigator

Corvia Medical

Eligibility Criteria

Adults over 18 with chronic heart failure, NYHA Class III/IV symptoms, and a history of hospitalization for heart failure. They must have reduced heart function (20-40% ejection fraction) and elevated left atrial pressure despite stable medication treatment. Excluded are those with recent cardiac procedures or devices, uncontrolled arrhythmias or blood pressure, severe lung disease, allergies to nickel, potential childbearing women without contraception use, significant liver impairment or life expectancy less than a year due to other diseases.

Inclusion Criteria

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

I was hospitalized or visited the ER for heart failure and received IV treatment in the last year.

A procedure to reach my heart through a vein in my leg is possible.

Exclusion Criteria

Your NT-Pro BNP or BNP levels are within certain ranges depending on your heart rhythm.

My heart's right side is not working properly.

I have severe heart issues and cannot walk far without getting tired.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

IASD System II is implanted in heart failure patients with reduced ejection fraction

Index Procedure

Initial Follow-up

Analysis of baseline and 1 month Core laboratory echocardiographic and hemodynamic data

1 month

Extended Follow-up

Participants are monitored for Major Adverse Cardiac and Cerebrovascular Events (MACCE) and systemic embolic events

6 months

Treatment Details

Interventions

• IASD implant

Trial Overview The trial is testing the safety and effectiveness of an IASD implant in patients with symptomatic heart failure who still have high left-sided heart pressures despite being on standard medications. The device aims to balance the pressures between the left and right sides of the heart.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

IASD Implantation

Who Is Running the Clinical Trial?

Corvia Medical

Lead Sponsor

Trials

8

Recruited

2,000+

Findings from Research

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]

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 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]

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]

References

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

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

2. 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]

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. France pubmed.ncbi.nlm.nih.gov

Creating interatrial shunts in heart failure and pulmonary hypertension. [2017]

5. 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]

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

Durable mechanical circulatory support devices. [2013]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Prognostic impact of implantable cardioverter defibrillators and associated adverse events in patients with continuous flow left ventricular assist devices. [2023]

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

Implantable cardioverter-defibrillators in cardiac transplant recipients: A systematic review from the Electrophysiology Collaborative Consortium for Meta-analysis-ELECTRAM investigators. [2021]

9. Japan pubmed.ncbi.nlm.nih.gov

The mid-term results of ventricular containment (ACORN WRAP) for end-stage ischemic cardiomyopathy. [2016]

10. Japan pubmed.ncbi.nlm.nih.gov

[Implantable Ventricular Assist Device]. [2019]