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Device

IASD Implant for Heart Failure

N/A
Waitlist Available
Research Sponsored by Corvia Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
One hospital admission for which HF was a major component of the hospitalization within the 12 months prior to study entry, or one emergency department visit with IV treatment for HF within the 12 months prior to study entry
Trans-septal catheterization by femoral vein access is determined to be feasible
Must not have
Right ventricular dysfunction
Atrial fibrillation with resting HR > 100 BPM
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new heart failure treatment in people who remain symptomatic despite other treatments. The goal is to see if it is safe and effective.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort at the implant site, risk of infection from surgery, allergic reactions to materials in the device such as nickel if applicable, irregular heartbeat risks associated with catheter-based procedures and possible impact on blood flow dynamics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was hospitalized or visited the ER for heart failure and received IV treatment in the last year.
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A procedure to reach my heart through a vein in my leg is possible.
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I have chronic heart failure with NYHA Class III or ambulatory IV symptoms in the past year.
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I am on a stable heart failure medication plan as per the 2016 guidelines.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My heart's right side is not working properly.
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I have atrial fibrillation with a resting heart rate over 100 BPM.
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I have severe liver problems.
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I need home oxygen or have serious lung disease.
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I am currently on immunosuppressants or systemic steroids.
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I am not on standard heart medication for specific reasons.
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I cannot take certain blood thinners or have a bleeding disorder.
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I have had a heart attack or heart surgery in the last 3 months.
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I am on dialysis or my kidney function is very low.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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
The percent of subjects left to right flow through the device
The percent of subjects who experience major adverse cardiac and/or cerebrovascular events (MACCE)
The percent of subjects who have successful device implantation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
IASD Implantation

Find a Location

Who is running the clinical trial?

Corvia MedicalLead Sponsor
7 Previous Clinical Trials
1,977 Total Patients Enrolled
7 Trials studying Heart Failure
1,977 Patients Enrolled for Heart Failure
Jan Komtebedde, DVMStudy DirectorCorvia Medical
2 Previous Clinical Trials
75 Total Patients Enrolled
2 Trials studying Heart Failure
75 Patients Enrolled for Heart Failure

Media Library

IASD implant (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03093961 — N/A
Heart Failure Research Study Groups: Intervention
Heart Failure Clinical Trial 2023: IASD implant Highlights & Side Effects. Trial Name: NCT03093961 — N/A
IASD implant (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03093961 — N/A
~2 spots leftby Dec 2026
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