Clinical Trial to Evaluate the Safety & Effectiveness of Using the Tendyne

Status Recruiting

Clinical Trial Summary

Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Protocol (MAC CAP). Subjects in the Randomized cohort will be randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-repairable, Severe MAC, and Severe MAC CAP cohorts will receive the trial device. The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) is to evaluate the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification. This randomized controlled trial will provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Transcatheter Mitral Valve System compared to the MitraClip System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved MitraClip indications. In addition, the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System will be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who are not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and are also not suitable for transcatheter repair with MitraClip, will be enrolled in the Non-repairable cohort. Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03433274
Study type	Interventional
Source	Abbott Medical Devices
Contact	Kayla Dellefratte
Phone	+1 (669)214-9748
Email	SUMMIT.Trial@abbott.com
Status	Recruiting
Phase	N/A
Start date	June 15, 2018
Completion date	June 2028

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05654272` - Development of CIRC Technologies
Recruiting	`NCT05650307` - CV Imaging of Metabolic Interventions
Recruiting	`NCT04515303` - Digital Intervention Participation in DASH
Completed	`NCT04056208` - Pistachios Blood Sugar Control, Heart and Gut Health	Phase 2
Recruiting	`NCT04417387` - The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
Not yet recruiting	`NCT06032572` - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)	N/A
Recruiting	`NCT04514445` - The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
Enrolling by invitation	`NCT04253054` - Chinese Multi-provincial Cohort Study-Beijing Project
Completed	`NCT03273972` - INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers	N/A
Completed	`NCT03680638` - The Effect of Antioxidants on Skin Blood Flow During Local Heating	Phase 1
Recruiting	`NCT04843891` - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.	Phase 1
Completed	`NCT04083872` - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting)	Phase 1
Completed	`NCT04083846` - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed)	Phase 1
Completed	`NCT03693365` - Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
Completed	`NCT03466333` - Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia	Phase 2
Completed	`NCT03619148` - The Incidence of Respiratory Symptoms Associated With the Use of HFNO	N/A
Completed	`NCT04082585` - Total Health Improvement Program Research Project
Completed	`NCT05132998` - Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors	N/A
Completed	`NCT05067114` - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed	`NCT04098172` - Evaluate the Performance and Safety of Comet Pressure Guidewire in the Measurement of FFR	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation — SUMMIT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms