Trial record 3 of 9 for:
accucinch
Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation - The CorCinch-PMVI Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03560167 |
Recruitment Status :
Active, not recruiting
First Posted : June 18, 2018
Last Update Posted : October 26, 2020
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Sponsor:
Ancora Heart, Inc.
Information provided by (Responsible Party):
Ancora Heart, Inc.
Tracking Information | ||||||||||
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First Submitted Date ICMJE | June 6, 2018 | |||||||||
First Posted Date ICMJE | June 18, 2018 | |||||||||
Last Update Posted Date | October 26, 2020 | |||||||||
Actual Study Start Date ICMJE | September 24, 2018 | |||||||||
Estimated Primary Completion Date | October 30, 2020 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
Safety measured by device-related or procedure-related major adverse events (MAEs) [ Time Frame: 30-day ] Device-related or procedure-related major adverse events (MAEs)
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Original Primary Outcome Measures ICMJE | Not Provided | |||||||||
Change History | ||||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | |||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation - The CorCinch-PMVI Study | |||||||||
Official Title ICMJE | An Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation - The CorCinch-PMVI Study | |||||||||
Brief Summary | This is a non-randomized, prospective, multi-center Early Feasibility Study of the AccuCinch® Ventricular Repair System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation. | |||||||||
Detailed Description | Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date August 14, 2020. | |||||||||
Study Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Not Applicable | |||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Device: AccuCinch® Ventricular Repair
AccuCinch® Ventricular Repair System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation
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Study Arms ICMJE | Experimental: AccuCinch® Ventricular Repair System
Intervention: Device: AccuCinch® Ventricular Repair
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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 | Active, not recruiting | |||||||||
Estimated Enrollment ICMJE |
15 | |||||||||
Original Enrollment ICMJE | Not Provided | |||||||||
Estimated Study Completion Date ICMJE | December 30, 2024 | |||||||||
Estimated Primary Completion Date | October 30, 2020 (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 | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries ICMJE | United States | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT03560167 | |||||||||
Other Study ID Numbers ICMJE | 5018 | |||||||||
Has Data Monitoring Committee | No | |||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | |||||||||
Responsible Party | Ancora Heart, Inc. | |||||||||
Study Sponsor ICMJE | Ancora Heart, Inc. | |||||||||
Collaborators ICMJE | Not Provided | |||||||||
Investigators ICMJE |
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PRS Account | Ancora Heart, Inc. | |||||||||
Verification Date | October 2020 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |