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
Effectiveness Progress
Study Objectives
1 Primary · 11 Secondary · Reporting Duration: Through 24 months
12 months
Cardiomyopathies
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
Safety Progress
Trial Design
2 Treatment Groups
Treatment
1 of 2
Control
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
Treatment
Device
Experimental Group · 1 Intervention: Corvia Atrial Shunt System / IASD System II · Intervention Types: DeviceControl
Other
ShamComparator Group · 1 Intervention: Intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) · Intervention Types: OtherTrial 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:References
- Borlaug, Barry A., John Blair, Martin W. Bergmann, Heiko Bugger, Dan Burkhoff, Leonhard Bruch, David S. Celermajer, et al.. 2022. “Latent Pulmonary Vascular Disease May Alter the Response to Therapeutic Atrial Shunt Device in Heart Failure”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.122.059486.
- Shah, Sanjiv J, Barry A Borlaug, Eugene S Chung, Donald E Cutlip, Philippe Debonnaire, Peter S Fail, Qi Gao, et al.. 2022. “Atrial Shunt Device for Heart Failure with Preserved and Mildly Reduced Ejection Fraction (REDUCE LAP-HF II): A Randomised, Multicentre, Blinded, Sham-controlled Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(22)00016-2.
- Shah SJ, Borlaug BA, Chung ES, Cutlip DE, Debonnaire P, Fail PS, Gao Q, Hasenfuss G, Kahwash R, Kaye DM, Litwin SE, Lurz P, Massaro JM, Mohan RC, Ricciardi MJ, Solomon SD, Sverdlov AL, Swarup V, van Veldhuisen DJ, Winkler S, Leon MB; REDUCE LAP-HF II investigators. Atrial shunt device for heart failure with preserved and mildly reduced ejection fraction (REDUCE LAP-HF II): a randomised, multicentre, blinded, sham-controlled trial. Lancet. 2022 Mar 19;399(10330):1130-1140. doi: 10.1016/S0140-6736(22)00016-2. Epub 2022 Feb 1.
- Borlaug BA, Blair J, Bergmann MW, Bugger H, Burkhoff D, Bruch L, Celermajer DS, Claggett B, Cleland JGF, Cutlip DE, Dauber I, Eicher JC, Gao Q, Gorter TM, Gustafsson F, Hayward C, van der Heyden J, Hasenfuss G, Hummel SL, Kaye DM, Komtebedde J, Massaro JM, Mazurek JA, McKenzie S, Mehta SR, Petrie MC, Post MC, Nair A, Rieth A, Silvestry FE, Solomon SD, Trochu JN, Van Veldhuisen DJ, Westenfeld R, Leon MB, Shah SJ; REDUCE LAP-HF-II Investigators. Latent Pulmonary Vascular Disease May Alter the Response to Therapeutic Atrial Shunt Device in Heart Failure. Circulation. 2022 May 24;145(21):1592-1604. doi: 10.1161/CIRCULATIONAHA.122.059486. Epub 2022 Mar 31. Erratum In: Circulation. 2022 Jul 26;146(4):e12.
- 2022. "RESPONDER-HF Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05425459.
Frequently Asked Questions
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer