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.
- Heart Failure
- Diastolic Heart Failure
1 Primary · 11 Secondary · Reporting Duration: Through 24 months
2 Treatment Groups
1 of 2
1 of 2
750 Total Participants · 2 Treatment Groups
Primary Treatment: Corvia Atrial Shunt System / IASD System II · Has Placebo Group · N/A
Who is running the clinical trial?
Age 18+ · All Participants · 10 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- 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
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