Corvia Atrial Shunt System / IASD System II for Heart Failure

Phase-Based Progress Estimates
The Alfred Hospital, Melbourne, AustraliaHeart Failure+1 MoreCorvia Atrial Shunt System / IASD System II - Device
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Heart Failure
  • Diastolic Heart Failure

Treatment Effectiveness

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Through 24 months

12 months
The change in New York Heart Association (NYHA) Class
Through 12 months
The incidence of newly acquired persistent or permanent atrial fibrillation (AF) or atrial flutter
The incidence of non-fatal, ischemic stroke
The incidence of participants with a ≥30% decrease in Tricuspid Annular Plane Systolic Excursion (TAPSE)
The incidence of thrombo-embolic complications including transient ischaemic attack (TIA) and systemic embolization)
The rate of new onset or worsening of kidney dysfunction
Through 24 months
The rate of heart failure (HF) admissions
Through 30 days
The rate of major adverse cardiac periprocedural events
Up to 12 months
Composite Primary Endpoint
The incidence of cardiovascular mortality
The rate of time-to-cardiovascular mortality

Trial Safety

Trial Design

2 Treatment Groups

1 of 2
1 of 2

Experimental Treatment

Non-Treatment Group

750 Total Participants · 2 Treatment Groups

Primary Treatment: Corvia Atrial Shunt System / IASD System II · Has Placebo Group · N/A

Experimental Group · 1 Intervention: Corvia Atrial Shunt System / IASD System II · Intervention Types: Device
ShamComparator Group · 1 Intervention: Intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through 24 months

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
7 Previous Clinical Trials
1,081 Total Patients Enrolled
3 Trials studying Heart Failure
728 Patients Enrolled for Heart Failure
Martin Leon, MDPrincipal InvestigatorColumbia University
3 Previous Clinical Trials
1,901 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

To what extent has the recruitment been successful for this experiment?

"Affirmative. As per, 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." - Anonymous Online Contributor

Unverified Answer

Are there still available enrollments for this research study?

"Affirmative. 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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.