← Back to Search

Device

Atrial Shunt Device for Heart Failure

N/A

Recruiting

Led By Sanjiv Shah, MD

Research Sponsored by Corvia Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chronic symptomatic heart failure (HF) documented by specific criteria including symptoms requiring current treatment with diuretics, New York Heart Association (NYHA) class II, III, or ambulatory NYHA class IV symptoms, and specific hospital admission or NT-proB-type Natriuretic Peptide (NT-pro BNP) values

Age ≥ 40 years old

Must not have

Advanced heart failure as defined by specific criteria

Severe depression and/or anxiety

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 24 months

Summary

This trial is testing a new treatment against a sham (fake) treatment, to see if the new treatment is better. Neither the patients nor the doctors will know which treatment each patient is receiving.

Who is the study for?

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.

What is being tested?

This 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.

What are the potential side effects?

Potential side effects may include complications from catheter insertion like bleeding or infection; risks associated with echocardiography such as discomfort or rare complications; adverse reactions related to the shunt device including improper placement or movement after implantation; and general anesthesia risks during procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have chronic heart failure and need diuretics, with symptoms that affect my daily activities.

Select...

I am 40 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My condition is advanced heart failure.

Select...

I am experiencing severe depression or anxiety.

Select...

I had or will have heart valve surgery recently, or my doctor says I have significant valve disease.

Select...

I do not have serious heart conditions or untreated issues that prevent certain treatments.

Select...

I have severe sleep apnea not treated with CPAP.

Select...

I am a woman who could become pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite Primary Endpoint

Secondary study objectives

Cardiomyopathies

The change in New York Heart Association (NYHA) Class

The incidence of cardiovascular mortality

+8 more

Trial Design

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.

0 / 8Eligibility criteria met