NCT04350372

MitraClip Russia Trial

The MitraClip Russia Trial: A Prospective, Single-Center, Single-Arm Clinical Evaluation of the MitraClip System for the Treatment of Mitral Regurgitation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The MitraClip System is the first commercially available catheter-based option for the treatment of MR. The MitraClip System was developed as an alternate percutaneous technology which may serve as a viable therapeutic option for patients at high risk for open-heart surgery. Treatment with the MitraClip device allows patients to undergo a less invasive procedure that can mechanistically reduce MR and allow for improved quality of life. The MitraClip procedure is performed under general anesthesia without the use of a heart-lung machine, with recovery typically lasting two to three days. The objective of this study is to evaluate safety and effectiveness of the MitraClip NT procedure in the Russian population for treatment of Mitral Regurgitation.

Detailed description

Mitral regurgitation (MR) is the most common heart valve condition in the world. MR occurs when the mitral valve does not close properly, allowing blood to leak back into the upper chamber of the heart. As a result, the heart may try to pump harder in order to compensate for the decrease in blood flow to the rest of the body. Patients with severe MR suffer from debilitating symptoms such as shortness of breath, heart palpitations, lightheadedness, and fatigue. These patients are at risk of poor quality of life, marked limitation in activity, repeated heart failure hospitalizations, and increased mortality. Chronic severe MR is often associated with heart failure and can lead to death if left untreated. While mitral valve repair or replacement surgery is currently regarded as standard of care, many patients with clinically significant MR are at an unacceptable risk of morbidity and mortality and are therefore not appropriate surgical candidates. To optimize afterload reduction and treatment of fluid load, these patients are often treated with medical management (i.e., beta blockers, ACE inhibitors, angiotensin II receptor blockers) which may relieve MR symptoms, but does not address the underlying cause of the condition. As a result, a significant portion of patients treated medically continue to progress to heart failure and experience an increasingly debilitating quality of life. A significant unmet clinical need thus exists for the treatment of moderate-to-severe and severe MR in high surgical risk patients. The MitraClip System has been in clinical use for treatment of significant MR since 2003. The device received CE (Conformité Européenne) Mark for both DMR and FMR indications in March 2008 and was approved by FDA for DMR indication in October 2013 and for FMR indication in March 2019. The system is approved for use in more than 80 countries or regions. More than 80,000 patients have undergone the MitraClip procedure worldwide, with the majority of experience in high surgical risk patients.

Conditions

• Functional Mitral Regurgitation
• Degenerrative Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	MitraClip Procedure	MitraClip procedure with MitraClip NT System

Timeline

• Start date: 2020-02-18
• Primary completion: 2020-09-24
• Completion: 2020-10-02
• First posted: 2020-04-17
• Last updated: 2022-06-14
• Results posted: 2022-06-14

Locations

1 site across 1 country: Russia

Regulatory

• FDA-regulated device study