NeoChord DS1000 vs. Surgery for Mitral Valve Regurgitation

(ReChord Trial)

Recruiting at 15 trial locations

Overseen By Marc Gerdisch, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NeoChord

Disqualifiers: Prior mitral surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

585 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the NeoChord DS1000 for individuals with degenerative mitral valve regurgitation, a condition where the heart's mitral valve doesn't close tightly, causing blood to leak backward. The study compares this new method, which repairs the valve without stopping the heart, to traditional surgical mitral valve repair that requires a heart-lung machine. It aims to determine if the new method is safe and effective. Suitable candidates have been informed by their doctor that they need mitral valve repair and have severe valve leakage affecting their daily life. As an unphased trial, this study offers patients the opportunity to access innovative treatment options that could improve their quality of life.

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 prior data suggests that the NeoChord DS1000 System is safe for mitral valve repair?

Research has shown that the NeoChord DS1000 system is generally safe for treating mitral valve regurgitation, a condition where the heart's mitral valve doesn't close properly. In past studies, patients using the NeoChord DS1000 experienced improvements in their heart condition, with fewer leaks in the mitral valve after treatment, marking a positive outcome.

Several studies have confirmed the safety of the NeoChord DS1000. One study demonstrated that the system can safely place artificial chordae, the cord-like structures in the heart. Most patients tolerated the procedure well, with no major complications. Another report from Canada showed favorable results in patients who underwent the procedure while their heart was still beating, without the need for a heart-lung machine.

Overall, these studies suggest that patients generally tolerate the NeoChord DS1000 system well. No major safety concerns have been reported in these studies, providing reassurance for those considering this treatment option. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the NeoChord DS1000 System because it offers a minimally invasive approach to treating mitral valve regurgitation. Unlike standard surgical mitral valve repair, which typically involves open-heart surgery, the NeoChord DS1000 uses artificial chordae that can be implanted without the need for a large incision. This method potentially reduces recovery time and lowers the risk of complications associated with traditional surgery. By providing a less invasive option, the NeoChord DS1000 could improve patient outcomes and overall treatment experience.

What evidence suggests that the NeoChord DS1000 System is effective for mitral valve regurgitation?

Research shows that the NeoChord DS1000 System, which participants in this trial may receive, effectively reduces mitral valve regurgitation, a condition where the heart's mitral valve doesn't close properly, causing blood to leak backward. Studies have demonstrated that this device can repair the mitral valve without stopping the heart or using a heart-lung machine. In one study, 83% of patients were still alive five years after the procedure, with similar outcomes across different patient groups. The NeoChord DS1000 treats patients by placing artificial tendons that support the heart valve through a minimally invasive method, leading to quicker recovery. Early results are promising, making this an important option for those seeking alternatives to traditional surgical mitral valve repair, which is the other treatment option in this trial. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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

My heart valve leak is moderate to severe.

I have a specific type of heart valve issue with a single abnormal blood flow detected.

My body is suitable for the treatment based on its structure and overall health.

Exclusion Criteria

I need additional heart-related procedures.

I have had surgery on my mitral valve before.

I have had heart surgery in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mitral valve repair using either the NeoChord DS1000 system or standard surgical techniques

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• NeoChord DS1000 System
• Surgical Mitral Valve Repair

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

Subjects with degenerative mitral valve insufficiency treated with artificial chordae implanted using the NeoChord DS1000

Group II: Control Group Active Control 1 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:

Approved in European Union as NeoChord DS1000 System for:

• Degenerative mitral valve regurgitation
• Mitral valve prolapse

Approved in United States as NeoChord DS1000 System for:

• Investigational Device Exemption (IDE) approval for clinical trial; not commercially approved

Who Is Running the Clinical Trial?

NeoChord

Lead Sponsor

Trials

5

Recruited

1,300+

Published Research Related to This Trial

The NeoChord DS1000 system was safely used in 13 patients with severe mitral regurgitation, achieving less than second-degree mitral regurgitation in 85% of cases after 6 months, indicating its efficacy in treating this condition.

The procedure was performed with a median duration of 113 minutes and had a low complication rate, with only one patient experiencing recurrent mitral regurgitation and another requiring conversion to conventional repair, suggesting that this minimally invasive technique is a promising option for mitral valve repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Off-pump transapical implantation of artificial chordae to correct mitral regurgitation: early results of a single-center experience. Rucinskas, K., Janusauskas, V., Zakarkaite, D., et al.[2022]

The NeoChord device was successfully used in a minimally invasive redo surgery for a 57-year-old man with severe mitral valve regurgitation, demonstrating its safety and feasibility in this challenging scenario.

The procedure resulted in only trivial residual mitral regurgitation, indicating effective repair and a favorable clinical outcome without the need for cardiopulmonary bypass.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transapical off-pump mitral valve repair following prior mitral valve surgery: A case report. Blessberger, H., Kellermair, J., Kammler, J., et al.[2023]

The NeoChord DS1000 system provides a minimally invasive option for treating degenerative mitral valve regurgitation (MR) in high-risk patients, with early outcomes showing significant reductions in MR severity and improved heart function after the procedure.

In a case series of 10 patients, the procedure was found to be safe, with no serious adverse events or device-related complications, and a low median hospital stay of 3 days, indicating its feasibility for off-pump mitral valve repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Echocardiographic and clinical outcomes following beating heart NeoChord DS1000 mitral valve repair: a single centre case series. Brown, A., Jefferson, HL., Fatehi Hassanabad, A., et al.[2023]

The transapical implantation of artificial chordae using the NeoChord system in 76 patients was performed safely under balanced anesthesia, with low perioperative morbidity and only 6.6% requiring blood transfusions.

Post-procedure, 56% of patients experienced trivial mitral regurgitation, demonstrating the efficacy of the NeoChord technique in significantly reducing severe mitral regurgitation, while transesophageal echocardiography played a crucial role in ensuring procedural success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anesthetic Management and Procedural Outcomes of Patients Undergoing Off-Pump Transapical Implantation of Artificial Chordae to Correct Mitral Regurgitation: Case Series of 76 Patients. Samalavicius, RS., Norkiene, I., Drasutiene, A., et al.[2018]

In a study of 18 patients undergoing minimally invasive mitral valve repair using the NeoChord DS1000™ system, all patients achieved successful repair with no major complications, indicating the procedure's safety and effectiveness.

At a median follow-up of 194 days, 94.5% of patients showed significant improvement in symptoms, and 72% had mild or no mitral regurgitation, along with favorable changes in heart chamber sizes and pressures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transapical off-pump mitral valve repair with NeoChord™ implantation: An early single-center Portuguese experience. Gonçalves-Teixeira, P., Costa, S., Martins, D., et al.[2021]

In a study of 21 patients with severe mitral regurgitation, the NeoChord DS1000 device achieved a 100% early procedural success rate, demonstrating its feasibility for mitral valve repair.

At the 6-month follow-up, 81% of patients showed only trace or mild mitral regurgitation, indicating a significant reduction in the severity of the condition and improvements in heart structure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Kurnicka, K., Wróbel, K., Zdończyk, O., et al.[2022]

The NeoChord DS1000 device for mitral valve repair has shown a high success rate, with 96.8% of the 249 patients achieving operative success, indicating its efficacy in treating severe mitral valve regurgitation.

The procedure is considered safe, with no intraoperative mortality reported and only minor complications such as arrhythmia (2.4%) and significant bleeding (3.2%) observed, suggesting it can be a viable option for selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transapical off-pump mitral valve repair with NeoChord implantation: A systematic review. Ahmed, A., Abdel-Aziz, TA., AlAsaad, MMR., et al.[2021]

Citations

1. neochord.com neochord.com/wp-content/uploads/2024/12/RP-602000-001_DS1000_SSCP_Rev_B_FINAL_05Dec2024.docx.pdf

Summary of Safety and Clinical Performance The device literature showed sufficient data to confirm that mitral valve repair using the NeoChord DS1000 results in reduction of MR and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01777815

Safety and Performance Study of the NeoChord Device The purpose of this study is to demonstrate the safety and performance of the NeoChord DS1000 Artificial Chordae Delivery System in implanting ePTFE sutures(s) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10326548/

Echocardiographic and clinical outcomes following beating ... We report the first Canadian case series using the NeoChord DS1000 system for off-pump, transapical, beating heart mitral valve repair, through ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02803957

NCT02803957 | Randomized Trial of the Neochord ... 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 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0022522322003877

Outcomes of transapical mitral valve repair with ... At 5 years, overall survival was 83% with no difference between FA and UA patients. Cumulative incidence of severe mitral regurgitation recurrence at 5 years ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0735109713051607

Off-Pump Transapical Implantation of Artificial Neo ... The goal of this study was to evaluate the safety and performance of the NeoChord DS1000 system (NeoChord, Inc., Minneapolis, Minnesota).