Feasibility Study of Dragonfly System for Severe Tricuspid Regurgitation

NCT04921605 | Unknown

• 1 other identifier: DragonFly-T-I
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to assess the feasibility of the DragonFly transcatheter mitral valve clamping system for the treatment of symptomatic severe tricuspid regurgitation.

Conditions

Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (2)

• Major adverse events

  Major adverse events included device- or procedure-related death, myocardial infarction, stroke, renal failure, and nonelective cardiovascular surgery associated with adverse events.

  30days

• Immediate procedural success

  Defined as successful implantation of a tricuspid valve-clamp device with at least a one-grade reduction in severity of tricuspid regurgitation at discharge (30-day echocardiography if discharge records were not available or were uninterpretable). Subjects who died or underwent tricuspid valve surgery prior to discharge were defined as immediate procedure failure.

  up to 30 days

Secondary Outcomes (8)

• All-cause mortality

  12, 24 months

• Cardiovascular-related mortality

  12, 24 months

• Serious adverse events

  12, 24 months

• Heart failure rehospitalization

  12, 24 months

• NYHA classification

  30 days, 6 months, 12 months and 24 months

Study Arms (1)

Tricuspid regurgitation

EXPERIMENTAL

Subjects received the Dragonfly system for the treatment of tricuspid regurgitation.

Device: DragonFly transcatheter mitral valve clamping system

Interventions

DragonFly transcatheter mitral valve clamping system DEVICE

To conduct edge-to-edge repair with Dragonfly System under the guidance of transesophageal echocardiography.

Tricuspid regurgitation

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years.
• Subject is medically treated, remains symptomatic and has severe tricuspid regurgitation confirmed by echocardiogram.
• New York Heart Function Class (NYHA) II-IVa, or hospitalization for heart failure due to one or more episodes in the past 12 months.
• Patient eligible for transcatheter tricuspid repair as well as suitable for use of the study device.
• Subject had an expected moderate or greater surgical risk confirmed by the cardiac surgeon, or the subject as not suitable for surgical thoracotomy confirmed by local doctor.
• Life expectancy ≥ 12 months.
• Subjects have been informed of the nature of the study, understand the purpose of the clinical trial, voluntarily participate, agree to its provisions, and have provided written informed consent approved by the Ethics Committee.

You may not qualify if:

• Tricuspid valve anatomy not suitable for device positioning or implantation as assessed by the clinical team, including but not limited to the following: a) calcification in the leaflet capture area; b) tricuspid valve perforation defect\>2 cm; c) severe tricuspid valve leaflet perforation, fissure and other lesions that preclude device implantation; d) Ebstein malformation.
• Presence of other serious valvular heart disease requiring intervention such as combined severe aortic stenosis or regurgitation, severe mitral regurgitation. Note: If combined with mitral and tricuspid valve lesions, mitral valve surgery can be selected first, and trial evaluation can be conducted after waiting for 60 days.
• Tricuspid stenosis, defined as tricuspid valve orifice area ≤ 1.0 cm2 and/or trans-tricuspid pressure difference ≥ 5 mmHg.
• After tricuspid surgery or tricuspid transcatheter treatment.
• Echocardiogram suggesting an intracardiac thrombus, vegetation, or mass; implant or thrombus in the femoral vein or inferior vena cava.
• Left ventricular ejection fraction (LVEF) ≤ 20%.
• Refractory heart failure requiring advanced intervention (eg, left ventricular assist device, heart transplant) (ACC/AHA stage D heart failure).
• Pulmonary artery systolic pressure\>70 mmHg, or irreversible pre-capillary pulmonary hypertension (measured by right heart catheter).
• Severe and uncontrolled hypertension: systolic blood pressure (SBP) ≥ 180 mmHg and diastolic blood pressure (DBP) ≥ 110 mmHg.
• Active endocarditis, active rheumatic heart disease, or rheumatic valvular heart disease leading to tricuspid valve leaflet lesions (poor leaflet compliance, perforation, etc.).
• After a pacemaker or ICD implantation.
• Myocardial infarction or unstable angina within 4 weeks; untreated severe coronary stenosis requiring revascularization.
• Percutaneous coronary intervention was performed within 30 days before surgery.
• Hemodynamic instability, defined as systolic blood pressure\<90mmHg with or without cardiogenic shock or requiring intra-aortic balloon counterpulsation or other hemodynamic support device.
• Cerebrovascular accident (CVA) within the previous 90 days.

Sponsors & Collaborators

• Hangzhou Valgen Medtech Co., Ltd: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Jianan Wang, MD, PH.D

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 10, 2021
• Study Start: December 15, 2020
• Primary Completion: September 15, 2022
• Study Completion: June 15, 2023
• Last Updated: March 29, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)