NL-OMON54518
Recruiting
Phase 3
Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure: a randomized trial (TAVR-UNLOAD) - TAVR-UNLOAD
Cardiovascular Research Foundation (CRF)0 sites56 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- aorta stenose
- Sponsor
- Cardiovascular Research Foundation (CRF)
- Enrollment
- 56
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age \>\=18 years
- •2\. Heart failure with NYHA class \>\= 2
- •3\. Under appropriate and stable guideline\-directed HF therapy for a minimum of
- •1 month prior to randomization. Note: Patients are expected to be on
- •appropriate pharmacologic therapy and if indicated CRT for heart failure. (12,
- •13\) Patients with aortic stenosis may not be able to tolerate maximal doses of
- •heart failure medications and no specific guidelines exist for the medical
- •treatment of heart failure in the setting of aortic stenosis. It is expected
- •that the heart failure PI will review the medical therapy and confirm that it
- •is appropriate for the patient\*s condition.
Exclusion Criteria
- •1\. LVEF \< 20% or persistent need for intravenous inotropic support
- •2\. Hospitalization for acute decompensated HF within 2 weeks prior to
- •randomization
- •3\. Cardiac resynchronization therapy (CRT) device implantation within 1 month
- •prior to randomization
- •4\. Coronary artery revascularization (PCI or CABG) within 1 month prior to
- •randomization
- •5\. In need and suitable for revascularization per heart team consensus
- •6\. Severe aortic and/or mitral regurgitation
- •7\. Congenital unicuspid or congenital bicuspid aortic valve
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Not Applicable
Surgical Replacement and Transcatheter Aortic Valve Implantation Trial 10 Year Follow-upsevere aortic valve stenosis10046973NL-OMON45149Medtronic B.V.160
Completed
Not Applicable
Transcatheter aortic valve replacement for patients with aortic valve stenosisSevere aortic valve stenosisJPRN-UMIN000009224Kurashiki Central Hospital Department of Cardiology Department of Cardiovascular Surgery20
Terminated
Not Applicable
Transcatheter Aortic Valve Replacement for Pure Severe Aortic Regurgitation, Pilot studyDiseases of the circulatory systemKCT0003085Asan Medical Center2
Recruiting
Not Applicable
Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve ReplacementNL-OMON53079Medtronic B.V.60
Active, not recruiting
Not Applicable
Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)Aortic Valve StenosisNCT02661451Cardiovascular Research Foundation, New York178