This trial is testing whether TAVR is safe and effective for heart failure patients with moderate aortic stenosis, as compared to those who receive no treatment.
- Aortic Valve Stenosis
4 Primary · 2 Secondary · Reporting Duration: 12 month
2 Treatment Groups
1 of 2
TAVR (with SAPIEN 3 THV) and OHFT
1 of 2
300 Total Participants · 2 Treatment Groups
Primary Treatment: Optimal Heart Failure Therapy · No 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:
- Esquitin, Kerry A., Omar K. Khalique, Qi Liu, Susheel K. Kodali, Leo Marcoff, Tamim M. Nazif, Isaac George, Torsten P. Vahl, Martin B. Leon, and Rebecca T. Hahn. 2019. “Accuracy of the Single Cycle Length Method for Calculation of Aortic Effective Orifice Area in Irregular Heart Rhythms”. Journal of the American Society of Echocardiography. Elsevier BV. doi:10.1016/j.echo.2018.11.018.
- 2016. "Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02661451.
Frequently Asked Questions
What is the aggregate tally of participants in this trial?
"To properly execute this study, Avania must find 300 volunteers meeting the inclusion criteria. The sponsor has decided to run clinical operations out of UCLA Medical Center in Los Angeles, Wisconsin and Advocate Aurora- St. Lukes in Milwaukee, Maine." - Anonymous Online Contributor
What is the geographic reach of this clinical experiment?
"To date, 47 patients have been enrolled in this trial at various locations such as UCLA Medical Center (Los Angeles), Advocate Aurora-St. Lukes (Milwaukee) and Maine Medical Centre (Portland). In addition to these sites, there are 44 other enrolment points across the US." - Anonymous Online Contributor
Are there still openings in this experiment that participants can take advantage of?
"Affirmative. According to the details posted on clinicaltrials.gov, this medical trial is now selecting participants and was first made public on September 1st 2016. The study requires 300 individuals from 47 different sites across the US." - Anonymous Online Contributor