NeoChord DS1000 vs. Surgery for Mitral Valve Regurgitation (ReChord Trial)
Recruiting in Palo Alto (17 mi)
+14 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: NeoChord
Disqualifiers: Prior mitral surgery, others
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve repair using standard surgical techniques with cardiopulmonary bypass (control group).
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment NeoChord DS1000 System for mitral valve regurgitation?
Research shows that the NeoChord DS1000 System, which uses a minimally invasive technique to repair the mitral valve, has been found to be a safe and effective treatment for mitral valve regurgitation. Studies indicate promising outcomes with minor complications, suggesting it is a feasible alternative to traditional surgery.
12345Is the NeoChord DS1000 system safe for humans?
The NeoChord DS1000 system has been shown to be generally safe in humans, with studies indicating it is a feasible procedure with minor complications and promising outcomes for treating mitral valve regurgitation.
34567How is the NeoChord DS1000 treatment different from other treatments for mitral valve regurgitation?
The NeoChord DS1000 treatment is unique because it is a minimally invasive procedure that repairs the mitral valve by implanting artificial chords through a small incision in the chest, without stopping the heart or using a heart-lung machine. This approach allows for a quicker recovery and fewer complications compared to traditional open-heart surgery.
13457Eligibility Criteria
This trial is for adults with moderate to severe degenerative mitral valve regurgitation who are suitable for standard surgical repair. Candidates should have specific conditions of the heart's mitral valve, like anterior leaflet prolapse, and must not have had prior mitral surgery or other cardiac procedures within the last 3 months.Inclusion Criteria
I have a specific type of heart valve issue with a single abnormal blood flow detected.
I am a candidate for heart valve repair surgery with a heart-lung machine.
My heart valve leak is moderate to severe.
My heart valve condition involves specific segments with a unique leakage pattern.
Exclusion Criteria
I need additional heart-related procedures.
I have had surgery on my mitral valve before.
Participant Groups
The study compares a new device called NeoChord DS1000, which repairs the heart's mitral valve without needing to stop the heart and use a bypass machine, against traditional open-heart surgery that does require stopping the heart and using bypass.
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment GroupExperimental Treatment1 Intervention
Subjects with degenerative mitral valve insufficiency treated with artificial chordae implanted using the NeoChord DS1000
Group II: Control GroupActive Control1 Intervention
Subjects with degenerative mitral valve insufficiency treated with standard surgical mitral valve repair
NeoChord DS1000 System is already approved in European Union, United States for the following indications:
๐ช๐บ Approved in European Union as NeoChord DS1000 System for:
- Degenerative mitral valve regurgitation
- Mitral valve prolapse
๐บ๐ธ Approved in United States as NeoChord DS1000 System for:
- Investigational Device Exemption (IDE) approval for clinical trial; not commercially approved
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
MedStar Washington Hospital CenterWashington, United States
University of Pittsburgh Medical CenterPittsburgh, PA
Piedmont Heart InstituteAtlanta, GA
Baylor - PlanoPlano, TX
More Trial Locations
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Who is running the clinical trial?
NeoChordLead Sponsor
References
Early echocardiographic results of transapical off-pump mitral valve repair with the NeoChord DS1000 device in patients with severe mitral regurgitation due to posterior leaflet prolapse: first experiences in Poland. [2022]Minimally invasive techniques of mitral valve (MV) repair have been increasingly used in recent years. Transapical implantation of artificial chordae on a beating heart under 2D/3D transesophageal echocardiographic guidance with the NeoChord DS1000 device is a new surgical treatment of degenerative mitral regurgitation (MR).
Anesthetic Management and Procedural Outcomes of Patients Undergoing Off-Pump Transapical Implantation of Artificial Chordae to Correct Mitral Regurgitation: Case Series of 76 Patients. [2018]Transapical implantation of artificial chordae using the NeoChord system (NeoChord Inc, Minneapolis, MN) is an emerging beating-heart technique for correction of mitral regurgitation (MR) through a minimally invasive left minithoracotomy. The purpose of the study was to describe the anesthetic management and procedural success of patients undergoing this procedure.
Echocardiographic and clinical outcomes following beating heart NeoChord DS1000 mitral valve repair: a single centre case series. [2023]The NeoChord DS1000 system implants artificial neochords transapically, through a left mini-thoracotomy to treat degenerative mitral valve regurgitation (MR). Performed without cardiopulmonary bypass, neochord implantation and length adjustment is guided by transesophageal echocardiography. We describe imaging and clinical outcomes for a single center case series using this innovative device platform.
Transapical off-pump mitral valve repair with NeoChord implantation: A systematic review. [2021]Mitral valve repair (MVr) is the gold standard for the treatment of degenerative mitral valve regurgitation (MR). The recently introduced NeoChord DS1000 has gained increasing recognition as a feasible, potentially safe, and effective procedure with minor complications and promising outcomes. This study aims to conduct a systematic review of the published literature that discusses the technical feasibility and outcome of transapical off-pump MVr with NeoChord DS1000 device implantation in the treatment of degenerative MR.
Off-pump transapical implantation of artificial chordae to correct mitral regurgitation: early results of a single-center experience. [2022]This study evaluated the safety and efficiency of the NeoChord DS1000 system (NeoChord, Inc, Minneapolis, Minn), a device designed to deliver artificial chordae tendineae (neochords) in a beating heart with minimally invasive techniques through left anterolateral minithoracotomy.
Transapical off-pump mitral valve repair following prior mitral valve surgery: A case report. [2023]Redo surgeries after mitral valve repair are technically demanding. Procedures applying the NeoChord device (NeoChord Inc, St. Louis Park, MN) have proven to be safe and feasible in selected patients requiring mitral valve repair due to a leaflet prolapse or flail. However, its use for redo procedures after conventional surgical repair has not been well established yet.
Transapical off-pump mitral valve repair with NeoChordโข implantation: An early single-center Portuguese experience. [2021]Transapical off-pump NeoChord DS1000โข implantation is a minimally invasive surgical mitral valve repair (MVr) procedure to treat degenerative mitral regurgitation (MR), which is performed using the NeoChord DS1000โข system with two and three-dimensional transesophageal echocardiographic guidance on a beating heart. It has been demonstrated to be safe and effective in carefully selected patients.