Actively Recruiting
The AcChord Study: A Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System
Led by NeoChord · Updated on 2020-07-10
500
Participants Needed
5
Research Sites
269 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are observing the long-term outcomes over five years in participants with degenerative mitral valve disease who have been treated using the NeoChord Artificial Chordae System, Model DS1000. This study focuses on patients with moderate to severe mitral valve regurgitation, aiming to gather real-world data in a post-market setting without introducing additional invasive procedures beyond standard treatment. The study is a single-arm, multicenter, observational registry allowing both prospective and retrospective enrollment. Participants have undergone mitral valve repair using the NeoChord device, which is designed to place artificial chordae when natural chordae tendinae are damaged due to degenerative valve disease. No extra invasive or burdensome examinations beyond those required for routine mitral valve repair are involved. Participants will be monitored primarily for the level of mitral regurgitation following their procedure. Secondary assessments will track mitral regurgitation levels at intervals up to five years after treatment. Data collection aligns with standard care visits, minimizing extra burden. The study will help assess the device's performance and patient outcomes over an extended period in routine clinical practice.
CONDITIONS
Brief Title
Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has Grade III Moderate or Grade IV Severe degenerative or mixed disease mitral valve regurgitation
- Study procedure completed after 31 December 2016
- Aged 18 years or older
You will not qualify if you...
- Heavily calcified valves
- Valvular retraction with severely reduced mobility
- Active bacterial endocarditis
- Complex mechanism of mitral regurgitation such as leaflet perforation
- Significant tethering of leaflets
- Inflammatory valve disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Procedure day
Participants undergo the mitral valve repair procedure using the NeoChord Artificial Chordae Delivery System as part of routine healthcare.
1 visit (in-person)
Duration - Up to 5 years
Participants are monitored for the level of mitral regurgitation and recovery following the procedure.
Follow-up visits at 3 to 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Trial Site Locations
Total: 5 locations
1
University of Bonn
Bonn, Germany
Actively Recruiting
2
CVC Frankfurt
Frankfurt, Germany
Actively Recruiting
3
University of Mainz
Mainz, Germany
Actively Recruiting
4
Hippokration Hospital
Athens, Greece
Actively Recruiting
5
Triemli Hospital
Zurich, Switzerland
Actively Recruiting
Research Team
A
Alexandar Jonkers
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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