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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 24 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have chronic heart failure and need diuretics, with symptoms that affect my daily activities.
Select...
I am 40 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite Primary Endpoint
Secondary outcome measures
Cardiomyopathies
The change in New York Heart Association (NYHA) Class
The incidence of cardiovascular mortality
+8 moreTrial 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.
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Who is running the clinical trial?
Corvia MedicalLead Sponsor
7 Previous Clinical Trials
1,237 Total Patients Enrolled
7 Trials studying Heart Failure
1,237 Patients Enrolled for Heart Failure
Sanjiv Shah, MDPrincipal InvestigatorNorthwestern Memorial Hospital
8 Previous Clinical Trials
2,089 Total Patients Enrolled
4 Trials studying Heart Failure
1,736 Patients Enrolled for Heart Failure
Martin Leon, MDPrincipal InvestigatorColumbia University
3 Previous Clinical Trials
1,707 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the study details and have signed the consent form.My condition is advanced heart failure.I am experiencing severe depression or anxiety.Your right ventricle is not functioning properly based on specific criteria.You have a device in your heart that helps control your heartbeat.I have no severe chronic conditions affecting my participation.I have chronic heart failure and need diuretics, with symptoms that affect my daily activities.The doctor needs to be able to access the heart through a vein in the leg.I had or will have heart valve surgery recently, or my doctor says I have significant valve disease.I am following a stable heart failure treatment plan as per the 2022 ACC/AHA guidelines.I have not had recent heart problems or treatments.I have a heart defect that's either present or was fixed with a patch.I do not have serious heart conditions or untreated issues that prevent certain treatments.Your body mass index (BMI) is higher than 45, or it's between 40 and 45 and the doctor doesn't think it's safe to get the treatment.Your heart has been shown to have specific problems with how it relaxes and fills with blood, as seen on an echocardiogram.I have severe sleep apnea not treated with CPAP.I am 40 years old or older.My heart's pumping ability is above 40% and hasn't dropped below 30% in the last 5 years.I am a woman who could become pregnant.You have a mass, blood clot, or growth in your heart seen on an echocardiogram.Your doctor has checked your heart and lung function during exercise and found that your pulmonary vascular resistance is less than 1.75 Wood units.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Treatment
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent has the recruitment been successful for this experiment?
"Affirmative. As per clinicaltrials.gov, this research is presently enrolling participants; the post date of which was November 17th 2022 and was recently updated on November 18th 2022. 750 patients are being sought from two specific locations."
Answered by AI
Are there still available enrollments for this research study?
"Affirmative. Clinicaltrials.gov showcases that this clinical trial, which first went live on November 17th 2022, is actively enrolling patients now. The study seeks to recruit 750 humans over 2 distinct medical facilities."
Answered by AI
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