IASD Implant for Heart Failure

Not currently recruiting at 5 trial locations

Overseen By Jan Komtebedde, DVM

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Corvia Medical

Must be taking: Guideline directed therapy

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Severe heart failure, Stroke, Valve disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Index Procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new implant called the IASD for people with heart failure. It aims to determine if the IASD can help those who still experience symptoms despite standard treatments. The trial seeks participants who have had heart failure symptoms, such as breathlessness or trouble sleeping due to breathing issues, and who have been hospitalized for heart issues within the last year. Participants should have a condition known as reduced ejection fraction, indicating inefficient heart pumping. The trial focuses on ensuring the implant's safety and effectiveness for these heart failure patients. As an unphased trial, this study offers patients a chance to contribute to pioneering research that could improve heart failure treatments.

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.

What prior data suggests that the IASD implant is safe for heart failure patients?

Research has shown that the IASD implant is generally safe for people with heart failure. In studies observing patients for up to a year, the IASD treatment did not raise major safety concerns. One study found that patients with heart failure and a heart function measure of 40% or more tolerated the IASD well. Another study confirmed that the device remained effective over time without causing significant problems.

The risk of serious side effects or death was low. Specifically, a long-term study estimated the risk of death at only 1.9%, indicating that the treatment is relatively safe. Overall, patients who received the IASD implant generally did well and showed improvements, making it a promising option for those who still have symptoms despite standard treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The IASD implant is unique because it tackles heart failure by directly reducing pressure in the left atrium, which is not addressed by most current treatments. Unlike standard medications that primarily focus on managing symptoms or fluid retention, the IASD implant works through a mechanical approach, creating a controlled shunt between the left and right atria to help relieve pressure. Researchers are excited about this treatment because it offers a novel mechanism of action that could improve quality of life for patients with heart failure, especially those who haven't found relief with existing therapies.

What evidence suggests that the IASD implant is effective for heart failure?

Studies have shown that the IASD implant, which participants in this trial will receive, can benefit people with heart failure whose hearts do not pump blood efficiently. A combined analysis of five studies revealed that patients experienced a significant improvement in their quality of life one year after receiving the IASD implant. One study found that the long-term death rate for heart failure patients with the implant was only 1.9%, indicating it is a safe option. Additionally, research involving 807 patients demonstrated improvements in heart function for those with the implant. These findings suggest that the IASD implant can effectively enhance heart performance and overall well-being for patients with certain heart failure conditions. ^{4 5 6 7 8}

Who Is on the Research Team?

Jan Komtebedde, DVM

Principal Investigator

Corvia Medical

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

IASD Implantation

Who Is Running the Clinical Trial?

Corvia Medical

Lead Sponsor

Trials

8

Recruited

2,000+

Published Research Related to This Trial

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]

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]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6351895/

Impact of an interatrial shunt device on survival and heart ... To determine the theoretical impact of IASD implantation on survival, we calculated 1 and 3 year predicted cohort outcomes using the Meta‐analysis Global Group ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0146280625001021

Safety and effectiveness after atrial shunt device in patients ... The long-term estimated pooled mortality of ASD in heart failure patients was 1.9% (95% CI: 0.1% to 3.8%), indicating it is a relatively safe option.

3. wjgnet.com wjgnet.com/1949-8462/full/v17/i10/112001

Efficacy and safety of interatrial shunt treatment for heart ... Cardiac output: This outcome was reported across seven studies, encompassing a total of 807 patients, 369 of whom received the IASD, while 438 ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ejhf.2360

Feasibility and efficacy of transcatheter interatrial shunt ... In a pooled analysis involving five studies, standardised HRQoL improved significantly at 12 months after IASD implantation by 17.7 points (95% ...

5. jacc.org jacc.org/doi/10.1016/j.jchf.2023.01.024

No-Implant Interatrial Shunt for HFpEF: 6-Month Outcomes ... The goal of this study was to investigate the safety and efficacy of a no-implant interatrial shunt for patients with heart failure with preserved ejection ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6233816/

One-Year Safety and Clinical Outcomes of a Transcatheter ... Through 1 year of follow-up, IASD treatment appears to be safe in patients with heart failure and ejection fraction equal to or greater than 40%. This ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30167646/

One-Year Safety and Clinical Outcomes of a Transcatheter ... The REDUCE LAP-HF I phase 2, sham-controlled RCT confirms the longer-term patency of the IASD. Through 1 year of follow-up, IASD treatment appears safe.

8. ahajournals.org ahajournals.org/doi/10.1161/circheartfailure.116.003662

One-Year Outcomes After Transcatheter Insertion of an ... These results provide evidence of safety and sustained clinical benefit in heart failure with preserved ejection fraction patients 1 year after interatrial ...