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Inter-Atrial Shunt Device
Inter-Atrial Shunt Device for Heart Failure
N/A
Waitlist Available
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
Age ≥ 40 years old
Chronic symptomatic Heart Failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is testing a device to see if it can help reduce pressure in the left atrium for people with heart failure.
Who is the study for?
This trial is for adults over 40 with chronic heart failure who have a left ventricular ejection fraction of at least 40% and elevated left atrial pressure. They must be on stable heart failure medication, able to do some exercise but not too much (can walk between 50m and 600m in six minutes), and their kidneys must work well enough (estimated-GFR ≥25ml/min/1.73 m2). People with severe heart failure, recent heart attacks or surgeries, significant untreated artery blockages, serious valve disease, or recent strokes aren't eligible.Check my eligibility
What is being tested?
The study tests the IASD System II device designed by Corvia Medical to lower high pressure in the left atrium of the heart in patients with Heart Failure. It also uses Intracardiac Echo as part of the procedure to help doctors see inside the heart better during treatment.See study design
What are the potential side effects?
Potential side effects may include complications from placing the device like bleeding or infection, irregular heartbeat due to irritation inside the heart where the device sits, blood clots that could lead to stroke if they travel through holes made by the shunt device.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 years old or older.
Select...
I have ongoing heart failure symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in supine exercise pulmonary capillary wedge pressure (PCWP)
Peri-procedural, and 1 month Major Adverse Cardiac, Cerebrovascular, and Renal Events (MACCRE)
Secondary outcome measures
Cardiovascular death
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ score)
Change in Quality Of Life Questionnaire (EQ-5D)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment with Inter-Atrial Shunt DeviceExperimental Treatment1 Intervention
Once all study criteria have been met, if randomized to this arm, patients will receive the IASD implant.
Group II: ControlPlacebo Group1 Intervention
Once all study criteria have been met, if randomized to this arm, patients will not receive the implant. They will undergo an intracardiac echo only, with the option to crossover at 1 year.
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Who is running the clinical trial?
Corvia MedicalLead Sponsor
7 Previous Clinical Trials
1,943 Total Patients Enrolled
7 Trials studying Heart Failure
1,943 Patients Enrolled for Heart Failure
Sanjiv Shah, MDPrincipal InvestigatorNorthwestern University
8 Previous Clinical Trials
2,795 Total Patients Enrolled
4 Trials studying Heart Failure
2,442 Patients Enrolled for Heart Failure
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on dialysis or my kidney function is very low.I am 40 years old or older.I have had a heart attack or heart surgery in the last 3 months.I started heart rhythm treatment within the last 6 months.I have ongoing heart failure symptoms.I have not had a stroke, TIA, DVT, or pulmonary emboli in the last 6 months.I have severe heart failure.I cannot walk 50m in 6 minutes, or I can walk more than 600m.I have a significant blockage in my neck artery that hasn't been treated.Your heart's pumping ability is at least 40%, and it has not been less than 30% in the past.I have a serious heart valve problem.My heart failure treatment and any other health conditions are currently stable.Your left atrial pressure during exercise is too high compared to your right atrial pressure.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment with Inter-Atrial Shunt Device
- Group 2: Control
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.
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