Health TrialsbyHealthPanel

Zhicheng TAVR Robot

ConditionAortic Stenosis Treated With TAVI
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-100
SponsorZhicheng Medical Technology (Jiaxing) Co, Ltd

About this trial

Use of the Transcatheter Aortic Valve Replacement Surgical Assist System and its Disposable Kit in Patients With Severe Aortic Stenosis to Evaluate the Safety and Efficacy of the Transcatheter Aortic Valve Replacement Surgical Assist System and its Disposable Kit for Use as an Adjunct to Transcatheter Aortic Valve Replacement

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥65 years old, gender is not limited;

Patients assessed by a cardiac multidisciplinary team (MDT) expert panel as having severe aortic stenosis and suitable for transcatheter aortic valve replacement;

Have a core laboratory assessment that the patient is anatomically suitable for transcatheter aortic valve replacement;

Patients who understand the purpose of the trial, voluntarily participate in the trial, sign an informed consent form, and are willing to cooperate in the follow-up.

Disqualifiers

Patients whose access or aortic root anatomical pattern is unsuitable for TAVR treatment;

Poor peripheral arterial conditions that preclude transfemoral TAVR;

Aortic annulus horizontal pinch angle ≥65° as measured by preoperative MDCT;

Patients at high risk of coronary obstruction requiring intraoperative coronary protection measures;

Trial design

Design model

Parallel

Treatments tested in this trial

  • TAVR Assistance System

    Device

    Whether or not TAVR procedures are performed with a TAVR assist system

  • TAVR by manual

    Other intervention

    TAVR by manual

Treatment groups

158 Participants
are divided into 2 treatment groups
Group A: TAVR with TAVR Assistance SystemExperimental treatment 1 intervention
Group B: TAVR By ManualPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Technical Success at exit from OR, hybrid room or cath lab post-index procedure

Absence of procedural mortality; and Successful access, delivery, and retrieval of transcatheter delivery system; and Deployment and correct positioning of a single intended THV; and Freedom from re-intervention related to the device or access procedure

Time frame
Immediate after procedure

Secondary outcomes

1

Device Success

Absence of procedure mortality; and Correct position of a single prosthetic heart valve Intended performance of the prosthetic heart valve (i.e., no prosthesis mismatch and mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s; and no moderate or severe prosthetic valve regurgitation) Intended performance of the prosthetic heart valve (i.e., no prosthesis mismatch and mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s; and no moderate or severe prosthetic valve regurgitation)

Time frame
30 days
2

Cardiac function changement

Cardiac function changement is accessed by NYHA cardiac function classification increases from baseline to 30 days

Time frame
Baseline，30 days
3

Prosthetic aortic valve function

Effective orifice area, mean transvalvular pressure difference, degree of regurgitation (mid-valve, peri-valve), degree of stenosis, etc.

Time frame
1、immediately after the procedure; 2、3 days; 3、30 days
4

Duration of aortic valve replacement

Time from start of delivery of prosthetic aortic valve by valve delivery system to successful implantation of prosthetic aortic valve

Time frame
During the procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhicheng Medical Technology (Jiaxing) Co, Ltd

Lead sponsor

Xiamen Cardiovascular Hospital, Xiamen University

Collaborator

Fu Wai Hospital, Beijing, China

Collaborator

Beijing Anzhen Hospital

Collaborator

The General Hospital of Northern Theater Command

Collaborator

Second Xiangya Hospital of Central South University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: