CORolla® TAA for Heart Failure With Preserved Ejection Fraction (HFpEF) and Diastolic Dysfunction (DD)
NCT02499601 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2020-10-08
Summary
The study objective is to demonstrate safety and feasibility of the CORolla® TAA during 12 months of follow up, and to evaluate the performance of the therapy in relieving symptoms and restore diastolic function in patients with heart failure and preserved ejection fraction.
Conditions
- Diastolic Heart Failure
- Diastolic Dysfunction
Interventions
- DEVICE
-
CORolla™ TAA device
Sponsors & Collaborators
-
CorAssist Cadiovascular Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-09-30
- Primary Completion
- 2021-09-30
- Completion
- 2024-09-30
Countries
- Israel
Study Locations
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