← Back to Search

Device

IASD System II Implant 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

NYHA class II with a history of > NYHA class II; OR NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening; or signs (any rales post cough, chest x-ray demonstrating pulmonary congestion,) within past 12 months;

Chronic symptomatic Heart Failure (HF) documented by one or more of the following:

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial is testing whether a new medical device is effective and safe.

Who is the study for?

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.Check my eligibility

What is being tested?

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).See study design

What are the potential side effects?

Possible side effects from the IASD System II implant may include complications related to the procedure such as bleeding or infection, issues with device placement, and potential impact on heart function.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

I have chronic heart failure with symptoms.

Select...

I am 40 or older with a heart function (EF) of 40% or more in the last 3 months, and never had EF below 30% in the past 3 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

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

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

Change in Kansas City Cardiomyopathy Questionnaire

Change in NYHA Class

Composite safety endpoint defined as follows

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 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: ControlPlacebo Group1 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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Corvia MedicalLead Sponsor

7 Previous Clinical Trials

1,379 Total Patients Enrolled

7 Trials studying Heart Failure

1,379 Patients Enrolled for Heart Failure

Sanjiv Shah, MDPrincipal InvestigatorNorthwestern Memorial Hospital

8 Previous Clinical Trials

2,231 Total Patients Enrolled

4 Trials studying Heart Failure

1,878 Patients Enrolled for Heart Failure

Marty Leon, MDPrincipal InvestigatorColumbia University

2 Previous Clinical Trials

3,000 Total Patients Enrolled

1 Trials studying Heart Failure

Media Library

IASD System II implant (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03088033 — N/A

Heart Failure Research Study Groups: Treatment, Control

Heart Failure Clinical Trial 2023: IASD System II implant Highlights & Side Effects. Trial Name: NCT03088033 — N/A

IASD System II implant (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03088033 — N/A

Heart Failure Patient Testimony for trial: Trial Name: NCT03088033 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there a number of health care facilities conducting this research endeavor within the state?

"Currently, 60 different medical centres are actively enrolling participants in this trial. People can find a clinic near them in Cincinnati, Miami and New york as well as other areas of the United States. It is important to consider proximity when selecting which centre you will join so that travel demands are kept to a minimum."

Answered by AI

Is this trial still enrolling participants?

"Per the information presented on clinicaltrials.gov, this medical research is not currently recruiting patients. It was initially published in June 2017 and last updated five years later in June 2022. Nevertheless, there are 701 other clinical trials that have openings at present."

Answered by AI

Who else is applying?

What state do they live in?

Iowa

Texas

Louisiana

How old are they?

18 - 65

What site did they apply to?

Medstar Washington Hospital Center

Holy Cross Hospital

Sarasota Memorial Hospital

Other

What portion of applicants met pre-screening criteria?

Met criteria

Did not meet criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

To Help Prevent others from having a Heart Attack. I like the idea of helping with medical research. Plus, I'm of the age where I should start to be concerned about Heart attacks. If this could prevent them for me, that would be amazing!

PatientReceived 1 prior treatment

I have tried every SSRI and an SNRI over the past 40 years, talk therapy, ketamine infusions, psilocybin retreats, seven weeks of TMS and a daily meditation practice for my MDD, and nothing has worked.

PatientReceived 2+ prior treatments

I have been on numerous medications for depression, some helped but only for a couple of years. Then I'd be put on something else. The past few years none of the meds I've been prescribed seem to work. I'm just tired of being depressed.

PatientReceived no prior treatments