Trials / Active Not Recruiting
Active Not RecruitingNCT05686317
ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System
A Randomized, Sham-controlled Clinical Trial for Evaluation of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW II)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, multi-center, randomized, sham-controlled, double-blinded (participant and outcomes assessor) clinical trial.
Detailed description
The objectives of this trial are to assess the safety, performance, and effectiveness of the Edwards APTURE transcatheter shunt system when used for the treatment of patients with heart failure with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction (LVEF \>40%) who remain symptomatic despite guideline-directed medical therapy (GDMT)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Edwards APTURE transcatheter shunt system | Treatment with APTURE shunt |
| DIAGNOSTIC_TEST | Sham procedure | CS angiography |
Timeline
- Start date
- 2023-04-01
- Primary completion
- 2026-11-01
- Completion
- 2030-08-31
- First posted
- 2023-01-17
- Last updated
- 2026-03-13
Locations
28 sites across 5 countries: United States, Brazil, Canada, Germany, Switzerland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05686317. Inclusion in this directory is not an endorsement.