IASD System II Implant for Heart Failure

Recruiting at 106 trial locations

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: 2

608 Participants Needed

Trial Summary

What is the purpose of this trial?

Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control group; 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 requires that your heart failure management remains stable without significant changes for at least 6 months, except for diuretic dose adjustments.

Is the IASD System II Implant safe for humans?

The IASD System II Implant 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 not yet available from randomized clinical trials. ^{1 2 3 4 5}

How is the IASD System II implant treatment different from other heart failure treatments?

The IASD System II implant is unique because it creates a small passage between the heart's upper chambers to reduce pressure in the left atrium, which can help improve symptoms in heart failure patients. This approach is different from traditional treatments that focus on medication or devices like pacemakers and defibrillators, as it directly alters blood flow to relieve pressure. ^{2 5 6 7 8}

Research Team

Sanjiv Shah, MD

Principal Investigator

Northwestern Memorial Hospital

Marty Leon, MD

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for adults over 40 with chronic heart failure, who have symptoms like shortness of breath or a history of hospital visits for heart failure. They should have a left ventricular ejection fraction of 40% or higher and be on stable heart failure medication. People can't join if they need dialysis, had recent major heart procedures, or have severe valve disease.

Inclusion Criteria

I have moderate to severe heart failure symptoms or signs in the past year.

I have been hospitalized or treated for heart failure, or my heart failure markers are high.

I have chronic heart failure with symptoms.

Exclusion Criteria

I have a serious untreated blockage in my neck artery that may need treatment.

I started heart rhythm treatment within the last 6 months.

I have had a heart attack, heart surgery, or a procedure to open my heart's arteries in the last 3-12 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Randomization and Procedure

Eligible patients are randomized to treatment or control group; treatment group undergoes IASD System II implant procedure, control group undergoes examination

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, with evaluations at pre-specified intervals

24 months

Multiple visits (in-person and virtual)

Long-term Follow-up

Participants are followed for long-term outcomes and safety for up to 5 years

5 years

Treatment Details

Interventions

• IASD System II implant
• Intra-Cardiac Echocardiography
• Transesophageal Echocardiography

Trial Overview The REDUCE LAP-HF TRIAL II is testing the IASD System II implant against standard care in people with heart failure. Participants are randomly assigned to either get the implant or not in equal numbers, and neither the participants nor the study team will know who got which treatment (blinded).

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Patients randomized to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and IASD System II implant procedure.

Group II: Control Placebo Group 1 Intervention

Patients randomized to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium.

Who Is Running the Clinical Trial?

Corvia Medical

Lead Sponsor

Trials

8

Recruited

2,000+

Findings from Research

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]

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]

References

1. 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]

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

Assessment of Predictors of Left Atrial Volume Response to a Transcatheter InterAtrial Shunt Device (from the REDUCE LAP-HF Trial). [2020]

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

Effect of coexisting cardiovascular disease on the long-term efficacy and safety of the implantable atrial defibrillator. [2019]

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

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

6. France pubmed.ncbi.nlm.nih.gov

[Indications for implantable automatic defibrillators: critical analysis]. [2018]

7. France pubmed.ncbi.nlm.nih.gov

[Implantable automatic defibrillators in the treatment of ventricular tachycardia]. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Treatment of atrial fibrillation with an implantable atrial defibrillator--long term results. [2019]