This trialtests a new device to help treat heart failure in adults on stable medical therapy.
- Heart Failure
- Heart Failure with Reduced Ejection Fraction
- Diastolic Heart Failure
6 Primary · 8 Secondary · Reporting Duration: Implant through end of study, approximately 5 years
4 Treatment Groups
Randomization to 6mm AFR device
1 of 4
Randomization to 10mm AFR device
1 of 4
Randomization to 8mm AFR device
1 of 4
Randomization to sham procedure
1 of 4
698 Total Participants · 4 Treatment Groups
Primary Treatment: Randomization to 6mm AFR device · Has Placebo Group · N/A
Who is running the clinical trial?
Age 18+ · All Participants · 0 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
Frequently Asked Questions
Are there any current opportunities for individuals to join this clinical experimentation?
"Indeed, the clinicaltrials.gov database has information which confirms that this medical trial is currently seeking applicants. It was first posted on November 1st 2022 and last edited on the 8th of the same month; moreover, a total of 698 patients need to be recruited from 4 different locations." - Anonymous Online Contributor
What is the primary objective of this investigation?
"This upcoming medical study seeks to measure the Composite Primary Efficacy Endpoint with a 12-month timeline. Additionally, Secondary objectives include Clinical performance change from Baseline assessed by NYHA Classification, EQ-5D, and 6 Minute Walk Test (MWT)." - Anonymous Online Contributor
How many medical sites are hosting the clinical trial?
"The current roster of medical centers offering this clinical trial includes Medstar in Washington, University of Mississippi Medical Center in Jackson, and Erlanger Health System in Chattanooga. There are 4 other sites available as well." - Anonymous Online Contributor
What is the maximum capacity for participation in this research project?
"Occlutech International AB will be carrying out the experiment in multiple locations, such as Medstar situated in Washington D.C and University of Mississippi Medical Centre located in Jackson, MS. The trial necessitates 698 individuals that meet its inclusion criteria for participants to take place successfully." - Anonymous Online Contributor