Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)
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ClinicalTrials.gov Identifier: NCT02661451 |
Recruitment Status :
Recruiting
First Posted : January 22, 2016
Last Update Posted : November 1, 2021
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Tracking Information | |||||||||
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First Submitted Date ICMJE | January 15, 2016 | ||||||||
First Posted Date ICMJE | January 22, 2016 | ||||||||
Last Update Posted Date | November 1, 2021 | ||||||||
Actual Study Start Date ICMJE | September 2016 | ||||||||
Estimated Primary Completion Date | March 2023 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Composite of all-cause death, disabling stroke and renal replacement therapy at 30 days, 6 months and 12 months [ Time Frame: 30 days, 6 months and 1 year ] Composite of all-cause death, disabling stroke and renal replacement therapy
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD) | ||||||||
Official Title ICMJE | Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure: A Randomized Trial (TAVR UNLOAD) | ||||||||
Brief Summary | The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as compared with OHFT. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Aortic Valve Stenosis | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Esquitin KA, Khalique OK, Liu Q, Kodali SK, Marcoff L, Nazif TM, George I, Vahl TP, Leon MB, Hahn RT. Accuracy of the Single Cycle Length Method for Calculation of Aortic Effective Orifice Area in Irregular Heart Rhythms. J Am Soc Echocardiogr. 2019 Mar;32(3):344-350. doi: 10.1016/j.echo.2018.11.018. Epub 2019 Jan 28. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
300 | ||||||||
Original Estimated Enrollment ICMJE |
600 | ||||||||
Estimated Study Completion Date ICMJE | March 2024 | ||||||||
Estimated Primary Completion Date | March 2023 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria All candidates for this study must meet all of the following inclusion criteria:
Exclusion Criteria Candidates are excluded from the study if any of the following conditions are present:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada, Netherlands, United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT02661451 | ||||||||
Other Study ID Numbers ICMJE | TAVR Unload | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||||
Current Responsible Party | Cardiovascular Research Foundation, New York | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Cardiovascular Research Foundation, New York | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE |
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Investigators ICMJE | Not Provided | ||||||||
PRS Account | Cardiovascular Research Foundation, New York | ||||||||
Verification Date | October 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |