NCT06136429

A Prospective, Multicenter, Single-arm Study to Evaluate a Transcatheter Aortic Valve System Safety and Efficacy for the Treatment of Patients With Severe Aortic Stenosis

Recruiting now NA Last updated 18 November 2023

What this trial tests

NA trial testing Transcatheter aortic valve replacement in Severe Aortic Stenosis in 120 participants. Currently enrolling.

Timeline

18 October 2023

Primary endpoint
30 December 2025

30 December 2029

Quick facts

Lead sponsor	Pan Xiangbin
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	18 October 2023
Primary completion	30 December 2025
Estimated completion	30 December 2029
Sites	1 location across China

Drugs / interventions tested

• Transcatheter aortic valve replacement

Conditions studied

• Severe Aortic Stenosis — all drugs for Severe Aortic Stenosis →

Sponsor

Pan Xiangbin

Who can join

70 and older, any sex, with Severe Aortic Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Trial Title: Prospective, multicenter, single-arm target value clinical trial to evaluate the safety and efficacy of a transcatheter aortic valve system in the treatment of patients with severe aortic stenosis Test device: Transcatheter aortic valve system. Pilot Phase: Clinical Validation of Class III Medical Devices. Study design: prospective, multicenter, single-group target value. Sample size: 120 cases. Intended Use: The Transcatheter Aortic Valve System is indicated for patients with a diagnosis of severe aortic stenosis by the Comprehensive Heart Team.

Objective: This clinical trial is a prospective, multicenter, single-arm study to evaluate the safety and efficacy of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis.

Primary endpoint: 12-month postoperative all-cause mortality All-cause deaths include cardiac death and non-cardiac death. Secondary Endpoints: 1. Device success rate 2. Procedural success rate 3. Delivery system performance 4. Retrieval system performance (e.g. using a recycling system) 5. Exchange system performance 6. Valvular function at Immediately postoperative, 7 days/at discharge, 30 days, 6 months, 12 months, 2-5 years follow-up: valve stenosis, regurgitation, valve function (e.g., opening area, pressure gradient), paravalvular leakage 7. Improvement in quality of life at 30 days, 6 months, 12 months postoperatively 8. Improvement in cardiac function at 7 days/at discharge, 30 days, 6 months, 12 months, 2-5 years postoperatively

Experimental design:

This trial is a prospective, multicenter, single-group clinical study with a target value to evaluate the Transcatheter Aortic Valve system Safety and efficacy in the treatment of patients with severe aortic stenosis with 12 months of All-cause mortality after transcatheter aortic valve implantation.

The mortality rate was the primary study endpoint, and after statistical assumptions and sample size calculations, 120 patients were planned to be enrolled.

Patients were clinically followed immediately after valve implantation, 7 days postoperatively/at discharge, 30 days, 6 months, 12 months, and 2-5 years postoperatively.

In this trial, all relevant clinical data were collected, sorted out and statistically analyzed by an independent data management and statistics center and a clinical monitoring institution. All enrolled subjects underwent outpatient follow-up at 30 days, 6 months, and 12 months after surgery, and performed relevant imaging examinations (ultrasound, etc.) and laboratory tests and safety evaluations, and continuous follow-up and cardiac ultrasound examinations were performed annually at 2-5 years to observe the occurrence of adverse events to evaluate the long-term safety of the transcatheter aortic valve system.

The safety and efficacy of the transcatheter aortic valve system were evaluated with the subject's 12-month postoperative all-cause mortality as the primary endpoint, and the immediate postoperative device success rate, procedural success, retrieval system performance, valve function, cardiac function improvement, quality of life improvement, all-cause mortality in different follow-up periods, major adverse cardiovascular and cerebrovascular events, myocardial infarction, stroke, hemorrhage, acute kidney injury, permanent pacemaker implantation, serious vascular complications, and other TAVR-related complications were taken as the secondary endpoints to assist in evaluating the safety and efficacy of the test product, and to provide a basis for the final official listing and domestic marketing.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.