All > Arizona > Delaware

Randomization to 6mm AFR device for Heart Failure

University of Arizona College of Medicine, Tucson, AZ
Heart Failure+1 More ConditionsAtrial Flow Regulator - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trialtests a new device to help treat heart failure in adults on stable medical therapy.

Eligible Conditions
  • Heart Failure
  • Heart Failure with Reduced Ejection Fraction
  • Diastolic Heart Failure

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Similar Trials

1
Vericiguat
1
CRD-740
1
LY3540378 Dose 1

Study Objectives

6 Primary · 8 Secondary · Reporting Duration: Implant through end of study, approximately 5 years

Month 24
Composite Primary Efficacy Endpoint - Frequency of Cardiovascular Mortality
Composite Primary Efficacy Endpoint - Frequency of heart transplant or Left Ventricular Assist Device (LVAD)
Composite Primary Efficacy Endpoint - Total rate of Heart Failure Hospitalizations
Composite Primary Efficacy Endpoint - Total rate of Heart Failure Treatment Intensification
Baseline through 12 months
Cardiovascular system
Baseline through 24 Months
Components of the primary efficacy endpoint (cardiovascular mortality, heart failure hospitalization rate, heart transplant or LVAD placement).
Month 6
Composite Primary Efficacy Endpoint - KCCQ Score
Year 5
Clinical performance - change from baseline in NYHA Classification
Clinical performance - change from baseline using EQ-5D
Clinical performance - change from baseline using KCCQ
Clinical performance - change from baseline using the 6 Minute Walk Test (MWT)
Year 5
Components of Device Performance - Patency: Evidence of left to right shunt through AFR device
Components of Device Performance- Device placed in-situ as assessed by Investigator
Components of Device Performance- Implant embolization and clinically significant device migration

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

2
Vericiguat
2
CRD-740
2
LY3540378 Dose 1

Trial Design

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

Active Control

Non-Treatment Group

698 Total Participants · 4 Treatment Groups

Primary Treatment: Randomization to 6mm AFR device · Has Placebo Group · N/A

Randomization to 6mm AFR device
Device
ActiveComparator Group · 1 Intervention: Atrial Flow Regulator · Intervention Types: Device
Randomization to 10mm AFR device
Device
ActiveComparator Group · 1 Intervention: Atrial Flow Regulator · Intervention Types: Device
Randomization to 8mm AFR device
Device
ActiveComparator Group · 1 Intervention: Atrial Flow Regulator · Intervention Types: Device
Randomization to sham procedure
Device
ShamComparator Group · 1 Intervention: Sham Comparator · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: implant through end of study, approximately 5 years

Who is running the clinical trial?

Occlutech International ABLead Sponsor
15 Previous Clinical Trials
3,581 Total Patients Enrolled
2 Trials studying Heart Failure
206 Patients Enrolled for Heart Failure
Muthiah Vaduganathan, MD, MPHPrincipal InvestigatorBrigham and Women's Hospital Heart and Vascular Center
Megan Coylewright, MD, MPH, FSCAI, FACCPrincipal InvestigatorErlanger Health System

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

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

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top