Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System

NCT04190602 · tracked via the Priya Life Science Germany tracker

Sponsor

NeoChord

Phase

Observational

Started

2020-02-09

Last updated

2020-07-10

Condition(s) studied

Mitral RegurgitationMitral Valve DiseaseMitral Valve InsufficiencyMitral Valve ProlapseHeart Valve Diseases

Investigational drug(s) / intervention(s)

NeoChord Artificial Chordae Delivery System, Model DS1000

NeoChord Artificial Chordae Delivery System, Model DS1000: The intended use of the device is for the placement of artificial chordae when the natural chordae tendinae have become elongated or ruptured due to degenerative valve disease.

Study summary

The objective of this study is to evaluate the 5-year outcomes of participants with degenerative mitral valve disease treated with the NeoChord Artificial Chordae System, Model DS1000 in a post-market setting.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Has Grade III Moderate or Grade IV Severe degenerative or mixed disease mitral valve regurgitation * Study procedure completed after 31 December 2016 Exclusion Criteria: * Heavily calcified valves * Valvular retraction with severely reduced mobility * Active bacterial endocarditis * Complex mechanism of MR (leaflet perforation, etc.) * Significant tethering of leaflets * Inflammatory valve disease

Primary outcome measure(s)

Level of Mitral Regurgitation Following the Index Procedure — Completion of Index Procedure
Level of mitral regurgitation per echocardiography

Trial sites (5)

Facility	City	Region	Status
University of Bonn	Bonn	Germany	Recruiting
CVC Frankfurt	Frankfurt	Germany	Recruiting
University of Mainz	Mainz	Germany	Recruiting
Hippokration Hospital	Athens	Greece	Recruiting
Triemli Hospital	Zurich	Switzerland	Recruiting

Other trials for the same condition

DragonFly EU Pivotal Study Recruiting

ATLAS (AltaValve) Pivotal Trial Recruiting

The EMBRACE Registry: European Post-Market Registry for Catheter Based Mitral Valve Replacement Starting soon

CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry Recruiting

Hamburg TranscathEteR Mitral Valve REplacement RegiStry Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04190602 on ClinicalTrials.gov ↗ ← All trials in Germany