NeoChord DS1000 vs. Surgery for Mitral Valve Regurgitation

(ReChord Trial)

Recruiting at 14 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

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. ^{1 2 3 4 5}

Is 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. ^{3 4 5 6 7}

How 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. ^{1 3 4 5 7}

Eligibility 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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

References

1. Poland 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. [2022]

2. United States 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. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Echocardiographic and clinical outcomes following beating heart NeoChord DS1000 mitral valve repair: a single centre case series. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Transapical off-pump mitral valve repair with NeoChord implantation: A systematic review. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Off-pump transapical implantation of artificial chordae to correct mitral regurgitation: early results of a single-center experience. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Transapical off-pump mitral valve repair following prior mitral valve surgery: A case report. [2023]

7. Spain pubmed.ncbi.nlm.nih.gov

Transapical off-pump mitral valve repair with NeoChord™ implantation: An early single-center Portuguese experience. [2021]