Clinical Trials Logo
  1. Home
  2. Mitral Valve Insufficiency
  3. NCT03285724

Safety and Performance Study of the Harpoon Mitral Valve Repair System

Mitral Valve Insufficiency Clinical Trial

Official title:
Safety and Performance Study of the Harpoon Medical Device in Patients With Degenerative Mitral Regurgitation

Clinical Trial Summary

The primary objective of this study is to evaluate the safety and performance of the Harpoon Medical Device. It is anticipated, that the Harpoon Medical Device will provide advantages over current surgical interventions including: 1) a small minimally invasive incision, 2) no sternotomy, 3) no cardiopulmonary bypass, 4) no aortic manipulation, 5) a direct path to the valve plane, 6) performed on a beating heart, 7) real-time TEE-guided ePTFE cordal length adjustment and 8) less complicated procedure that is teachable and adoptable.

Clinical Trial Description

The device is designed to reduce the degree of mitral regurgitation by delivering and anchoring artificial chordae tendineae to the affected mitral valve leaflet(s) in a beating heart. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03285724
Study type Interventional
Source Edwards Lifesciences
Contact
Status Terminated
Phase N/A
Start date May 16, 2017
Completion date April 20, 2018
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03962023 - Prognostic Impact of Imaging Parameters in Patients With Primary Mitral Insufficiency by Prolapse (COHORTE-IM)
Withdrawn NCT02624960 - Safety and Performance of the AccuCinch® System N/A
Terminated NCT02428010 - Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study N/A
Active, not recruiting NCT01533883 - Cardioband Adjustable Annuloplasty System for Minimally Invasive Mitral Valve Repair N/A
Unknown status NCT01201070 - Study of Administration Of Antithrombin in Patients With Low Plasmatic Levels of Antithrombin After Cardiac Surgery Phase 4
Terminated NCT00700947 - Using Beta Blockers to Treat Mitral Regurgitation Phase 1
Completed NCT04351984 - Transcatheter Mitral Valvuloplasty Pilot Study
Completed NCT04231331 - Ertugliflozin for Functional Mitral Regurgitation Phase 3
Completed NCT05742789 - Effect of Anesthetics on Troponin I and ะก-reactive Protein Phase 1
Recruiting NCT02803957 - Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair N/A
Recruiting NCT04153292 - The ENCIRCLE Trial N/A
Completed NCT02607527 - Annular Reshaping of the Mitral Valve for Patients With Mitral Regurgitation Using the Millipede IRIS System N/A
Active, not recruiting NCT03066050 - Long Term Follow Up for CTSN Mitral Valve Repair Studies
Active, not recruiting NCT04443218 - Edwards PASCAL Transcatheter Valve Repair System Registry
Enrolling by invitation NCT04067635 - Primary Mitral Regurgitation Repair
Completed NCT01966146 - Examination of Valve Insufficiency Before and After MitraClip or TAVI Procedure by 3D Echocardiography Compared to MRI N/A
Recruiting NCT01368575 - Surgical Treatment of Ischemic Mitral Regurgitation Phase 4
Completed NCT00001314 - Investigation of Heart Function in Patients With Heart Valve Defects N/A
Withdrawn NCT04709042 - Acquisition of Objective Data During Transapical Neochordae Implantation N/A
Recruiting NCT03525041 - Mitral Valve Repair Combined Coronary Artery Bypass Grafting(CABG) Verus CABG Alone on Functional Ischemic Mitral Regurgitation N/A