Dawneo Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System Pivotal Clinical Trial in Patients With Severe Tricuspid Regurgitation

NCT05497141 | Unknown

• 1 other identifier: 2022YLK17
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and effectiveness of Dawneo Neoblazar® transcatheter tricuspid valve edge-to-edge repair system in patients with severe tricuspid regurgitation. This is a prospective, multicenter, randomized, objective performance criteria trial. 98 patients who meet the inclusion criteria will be included in the study. This study will be conducted in in each site as run-in subjects. Subjects who meet the requirements and who voluntarily participate in the trial and sign the informed consent form, will be implanted with the Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System.

Conditions

Tricuspid Regurgitation

Keywords

sever tricuspid regurgitation; edge-to edge repair system; heart failure

Outcome Measures

Primary Outcomes (1)

• Rate of Implantation Success

  1. No all-cause mortality after implantation; 2. No tricuspid open surgery after implantation; 3. tricuspid regurgitation reduction at least 1 grade.

  12 months

Secondary Outcomes (4)

• Initial Success

  1 week

• NYHA Functional Class

  30 days, 6 months, 12 months, annual for five years

• Six-minute walk test

  30 days, 6 months, 12 months, annual for five years

• Reduction in TR grade

  30 days, 6 months, 12 months, annual for five years

Study Arms (1)

tricuspid valve edge-to edge Repair group

EXPERIMENTAL

Subjects who received Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System will be included in this arm

Device: Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System

Interventions

Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System DEVICE

Subjects who received Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System will be included in this arm. The Neoblazar® is intended for reconstruction of the insufficient tricuspid valve through tissue tissue approximation.

tricuspid valve edge-to edge Repair group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects of age \> 18 years;
• Subjects suffering from severe tricuspid regurgitation (TR≥3+), defined by TTE or TEE;
• Subject has symptoms with NYHA ≥ Class II-Iva, or at least one hospitalization for symptoms of heart failure during the past 12 months.
• Subjects with two cardiac surgeons agreements of contraindications to surgery or high risk, who meets at least one of the following three conditions:
• ① Euroscore≥8%；
• ② Presence of 2 or more Frailty Index；
• ③ Presence of 2 or more organ insufficiencies。
• Subjects who's tricuspid valve anatomy are suitable for transcatheter valve edge-to-edge repairment as assessed.
• Subjects agreeing to the scheduled follow up requirements, who can understand the purpose of the clinical investigation, and sign voluntarily the informed consent form by themselves and/or the subject' legal guardians.

You may not qualify if:

• Pulmonary artery systolic pressure \>70 mmHg measured by transthoracic echocardiography or right heart catheterization, or irreversible precapillary pulmonary hypertension;
• The presence of calcification in the grasping area of the tricuspid valve leaflets (including the anterior, septal, and posterior leaflets) that affects clamping, and the thickness of the tricuspid valve leaflets≥4mm;
• Severe tricuspid leaflet perforation, cleft or other lesions which preventing the implantation;
• Tricuspid valve leaflets coaptation gap \>7mm
• Tricuspid stenosis as assessed by echocardiography (defined as tricuspid orifice area ≤1.0 cm2)
• LVEF≤20%；
• Refractory heart failure requiring advanced intervention (e.g., left ventricular assist device, heart transplantation, etc.) (ACC/AHA stage D heart failure);
• Myocardial infarction or unstable angina within 4 weeks;
• Untreated severe coronary artery stenosis requiring revascularization;
• Received percutaneous coronary intervention within 1 month prior to implantation;
• Severe and uncontrolled hypertension: SBP≥180mmHg or DBP≥110mmHg;
• Previously implantation of tricuspid valve, annuloplasty ring or accepted tricuspid valve repair surgery;
• Pacemaker leads or ICD leads that may affect implantation
• Complications of other cardiac diseases requiring surgical intervention;
• Tricuspid leaflet lesions due to rheumatic heart disease (e.g., leaflet grossness, thickening, poor compliance, etc.);

Sponsors & Collaborators

• Xiamen Cardiovascular Hospital, Xiamen University: lead

Study Sites (1)

Xiamen Cardiovascular Hospital Xiamen University

Xiamen, Fujian, 361000, China

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Heart Failure

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Yan Wang, Dr

  Clinical Trial Center of Xiamen Cardiovascular Hospital

  PRINCIPAL INVESTIGATOR

• Nianguo Dong, Dr

  Wuhan Xiehe Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiang Chen, Dr

CONTACT

18033997788; Seanchenx@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2022
• First Posted: August 11, 2022
• Study Start: July 22, 2022
• Primary Completion: August 22, 2023
• Study Completion: October 22, 2023
• Last Updated: August 11, 2022

Record last verified: 2022-08

Locations

CN (1)