Trial record 2 of 3 for:
triluminate
TRILUMINATE Pivotal Trial
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ClinicalTrials.gov Identifier: NCT03904147 |
Recruitment Status :
Recruiting
First Posted : April 5, 2019
Last Update Posted : February 1, 2023
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Sponsor:
Abbott Medical Devices
Information provided by (Responsible Party):
Abbott Medical Devices
Tracking Information | ||||||||||
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First Submitted Date ICMJE | April 3, 2019 | |||||||||
First Posted Date ICMJE | April 5, 2019 | |||||||||
Last Update Posted Date | February 1, 2023 | |||||||||
Actual Study Start Date ICMJE | August 21, 2019 | |||||||||
Actual Primary Completion Date | June 29, 2022 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
Hierarchical composite of number of participants with all-cause mortality or number of participants with tricuspid valve surgery, rate of heart failure hospitalizations, and assessment of quality of life improvement using the KCCQ [ Time Frame: 12 Months ] | |||||||||
Original Primary Outcome Measures ICMJE |
Hierarchical composite of all-cause mortality or tricuspid valve surgery, heart failure hospitalizations, and quality of life improvement assessed using the KCCQ [ Time Frame: 12 Months ] | |||||||||
Change History | ||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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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 | TRILUMINATE Pivotal Trial | |||||||||
Official Title ICMJE | Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal | |||||||||
Brief Summary | The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (TriClip device) to Control (Medical Therapy). | |||||||||
Detailed Description | Not Provided | |||||||||
Study Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Not Applicable | |||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Tricuspid Regurgitation | |||||||||
Intervention ICMJE | Device: Tricuspid valve repair
Transcatheter TriClip placement in the tricuspid valve to repair the valve and correct regurgitation
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Study Arms ICMJE |
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Publications * | Not Provided | |||||||||
* 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 |
700 | |||||||||
Original Estimated Enrollment ICMJE | Same as current | |||||||||
Estimated Study Completion Date ICMJE | December 2028 | |||||||||
Actual Primary Completion Date | June 29, 2022 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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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, Germany, Italy, Spain, United States | |||||||||
Removed Location Countries | Switzerland | |||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT03904147 | |||||||||
Other Study ID Numbers ICMJE | CRD_946 | |||||||||
Has Data Monitoring Committee | Yes | |||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Abbott Medical Devices | |||||||||
Original Responsible Party | Same as current | |||||||||
Current Study Sponsor ICMJE | Abbott Medical Devices | |||||||||
Original Study Sponsor ICMJE | Same as current | |||||||||
Collaborators ICMJE | Not Provided | |||||||||
Investigators ICMJE |
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PRS Account | Abbott Medical Devices | |||||||||
Verification Date | January 2023 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |