- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04190602
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
- Name: Alexandar Jonkers
- Phone Number: +31 610740977
- Email: ajonkers@neochord.com
Study Locations
-
-
-
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
-
-
-
-
-
Athens, Greece
- Recruiting
- Hippokration Hospital
-
Principal Investigator:
- Vasileios Lozos, MD
-
-
-
-
-
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
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
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
-
National Heart, Lung, and Blood Institute (NHLBI)WithdrawnHeart Failure | Aortic Valve Stenosis | Mitral Valve Regurgitation | Heart Valve Disease | Tricuspid Valve RegurgitationUnited States
-
Edwards LifesciencesActive, not recruitingHeart Failure | Mitral Valve Insufficiency | Mitral Valve Regurgitation | Mitral Valve DiseaseUnited States, Australia, Brazil
-
Assistance Publique Hopitaux De MarseilleSuspendedAortic Valve Regurgitation AcquiredFrance
-
Caisson Interventional LLCActive, not recruitingMitral Regurgitation | Valve Disease, Heart | Valve Heart Disease | Mitral Valve Disease | Mitral Valve Failure | Mitral DiseaseUnited States
-
Medical College of WisconsinChildren's Hospital and Health System Foundation, WisconsinCompletedMitral Valve Regurgitation | Tricuspid Valve Regurgitation, Non-rheumaticUnited States
-
UMC UtrechtLeiden University Medical Center; The Interuniversity Cardiology Institute... and other collaboratorsTerminatedMitral Valve Insufficiency | Diseases of Mitral Valve | Heart; Disease, Mitral(Valve)Netherlands
-
Maria Cecilia HospitalRecruiting
-
Edwards LifesciencesRecruitingCardiovascular Diseases | Heart Failure | Heart Valve Diseases | Tricuspid Valve Regurgitation | Tricuspid Valve Insufficiency | Tricuspid Valve DiseaseUnited States, Germany
-
Synecor, LLCUnknownHeart Failure | Mitral Valve Insufficiency | Mitral Valve Regurgitation | Mitral Valve Disease
-
Deutsches Herzzentrum MuenchenRecruitingMitral Valve Stenosis | Mitral Valve Regurgitation | Tricuspid Valve RegurgitationGermany
Clinical Trials on NeoChord Artificial Chordae Delivery System, Model DS1000
-
NeoChordCompletedMitral Valve RegurgitationDenmark, Germany, Italy, Lithuania
-
Imperial College LondonCompletedType 1 Diabetes MellitusUnited Kingdom
-
Sansum Diabetes Research InstituteMayo Clinic; Icahn School of Medicine at Mount Sinai; Harvard UniversityCompletedType 1 Diabetes | PregnancyUnited States
-
Air Liquide Santé InternationalCompleted
-
Peijia Medical Technology (Suzhou) Co., Ltd.General Hospital of Shenyang Military Region; Shanghai Zhongshan Hospital; China... and other collaboratorsCompleted
-
London School of Hygiene and Tropical MedicineMedical Research Council; Chiang Mai UniversityNot yet recruitingDiabetes Mellitus, Type 2
-
Shanghai Zhongshan HospitalShanghai Fifth People's Hospital,Fudan UniversityNot yet recruiting
-
Sansum Diabetes Research InstituteUniversity of California, Santa BarbaraCompletedType 1 Diabetes MellitusUnited States