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

July 9, 2020 updated by: NeoChord

The AcChord Study: A Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is an observational, single-arm, multicenter post-market registry. Both prospective and retrospective enrollment will be allowed. No additional invasive or burdensome examinations outside those routinely required for the standard mitral valve repair procedure will be requested.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Bonn, Germany
        • Recruiting
        • University of Bonn
      • Frankfurt, Germany
        • Recruiting
        • CVC Frankfurt
        • Principal Investigator:
          • Horst Sievert, MD PhD
      • Mainz, Germany
        • Recruiting
        • University of Mainz
        • Principal Investigator:
          • Andres Beiras Fernandez, MD PhD
  • Greece
      • Athens, Greece
        • Recruiting
        • Hippokration Hospital
        • Principal Investigator:
          • Vasileios Lozos, MD
  • Switzerland
      • Zurich, Switzerland
        • Recruiting
        • Triemli Hospital
        • Principal Investigator:
          • Omer Dzemali, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients who meet the indications and are not contraindicated for treatment by the NeoChord Artificial Chordae Delivery System, Model DS1000.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of Mitral Regurgitation Following the Index Procedure
Time Frame: Completion of Index Procedure
Level of mitral regurgitation per echocardiography
Completion of Index Procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of Mitral Regurgitation at 3-6 Months
Time Frame: 3-6 Months
Level of mitral regurgitation per echocardiography
3-6 Months
Level of Mitral Regurgitation at 1 Year
Time Frame: 1 Year
Level of mitral regurgitation per echocardiography
1 Year
Level of Mitral Regurgitation at 2 Years
Time Frame: 2 Years
Level of mitral regurgitation per echocardiography
2 Years
Level of Mitral Regurgitation at 3 Years
Time Frame: 3 Years
Level of mitral regurgitation per echocardiography
3 Years
Level of Mitral Regurgitation at 4 Years
Time Frame: 4 Years
Level of mitral regurgitation per echocardiography
4 Years
Level of Mitral Regurgitation at 5 Years
Time Frame: 5 Years
Level of mitral regurgitation per echocardiography
5 Years

Other Outcome Measures

Outcome Measure
Time Frame
Freedom from Mitral Valve Re-intervention
Time Frame: From enrollment until date of mitral valve reintervention, up to 5 years
From enrollment until date of mitral valve reintervention, up to 5 years
Freedom from All-Cause Mortality
Time Frame: From enrollment until date of death, up to 5 years
From enrollment until date of death, up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeoChord

Investigators

  • Principal Investigator: Andres Beiras Fernandez, MD PhD, Johannes Gutenberg University Mainz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2020

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

December 1, 2027

Study Registration Dates

First Submitted

December 4, 2019

First Submitted That Met QC Criteria

December 5, 2019

First Posted (Actual)

December 9, 2019

Study Record Updates

Last Update Posted (Actual)

July 10, 2020

Last Update Submitted That Met QC Criteria

July 9, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR-610414-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Valve Diseases

Clinical Trials on NeoChord Artificial Chordae Delivery System, Model DS1000

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe