Trials / Unknown
UnknownNCT03751748
Flow Regulation by Opening the Septum in Patients With Heart Failure Trial
Flow Regulation by Opening the Septum in Patients With Heart Failure (FROST-HF) Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 230 (estimated)
- Sponsor
- Unity Health Toronto · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To investigate the safety and efficacy of a novel atrial flow regulator (AFR) device in patients with heart failure and preserved ejection fraction.
Detailed description
The study will allow us to demonstrate the safety of the AFR device as well as determine the clinical response of the therapeutic intervention. In addition, the invasive exercise hemodynamics will provide objective data for the changes in the cardiac hemodynamics and delineate underlying mechanisms of creating a permanent inter atrial shunting.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AFR implantation | Implantation of atrial flow regulator (AFR) device |
| DEVICE | Sham procedure | Sham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo |
Timeline
- Start date
- 2019-01-01
- Primary completion
- 2020-12-31
- Completion
- 2021-04-30
- First posted
- 2018-11-23
- Last updated
- 2018-11-23
Locations
3 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT03751748. Inclusion in this directory is not an endorsement.