Zhicheng TAVR Robot

NCT07392359 | Not Yet Recruiting DMC

• 1 other identifier: 1RAD0008
• Study Type: interventional
• Target: 158
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Aortic Stenosis Treated With TAVI

Keywords

TAVR Assist System; Aortic stenosis treated with TAVI

Outcome Measures

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

  Immediate after procedure

Secondary Outcomes (7)

• Device Success

  30 days

• Cardiac function changement

  Baseline，30 days

• Prosthetic aortic valve function

  1、immediately after the procedure; 2、3 days; 3、30 days

• Duration of aortic valve replacement

  During the procedure

• Total exposure of the operator to radiation

  During the procedure

Study Arms (2)

TAVR with TAVR Assistance System

EXPERIMENTAL

Device: TAVR Assistance System

TAVR By Manual

PLACEBO COMPARATOR

Other: TAVR by manual

Interventions

TAVR Assistance System DEVICE

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

TAVR with TAVR Assistance System

TAVR by manual OTHER

TAVR by manual

TAVR By Manual

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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;
• \*Severe aortic stenosis was defined as echocardiographically demonstrated transaortic valve flow velocity ≥4.0 m/s, or transaortic valve pressure differential ≥40 mmHg (1 mmHg=0.133 kPa), or aortic orifice area \<1.0 cm2, or effective aortic orifice area index \<0.6 cm2/m2; for low-pressure-differential-low-flow rate by dopa-phenobutylamine loading test, Doppler ultrasound evaluation or other imaging means of assessment for those judged to have severe aortic stenosis.
• 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.

You may not qualify if:

• 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;
• Patients requiring intraoperative delivery with a grapple assist system;
• Previous implantation of a prosthetic aortic valve (bioprosthetic or mechanical);
• Active stage of infective endocarditis or other active infection;
• Combined mitral, tricuspid or severe macrovascular lesions requiring surgical or interventional intervention;
• Echocardiography suggestive of left ventricular thrombus, intracardiac mass or redundant organisms;
• Diagnosis of hypertrophic cardiomyopathy, restrictive cardiomyopathy, infiltrative cardiomyopathy (e.g. amyloidosis, haemochromatosis, nodular disease, etc.), constrictive pericarditis;
• Severe obstruction of the left ventricular outflow tract without corrective measures;
• Severe pulmonary hypertension (pulmonary artery systolic pressure \>70 mmHg measured by ultrasound);
• Severe right heart dysfunction as suggested by a combined clinical and ultrasound assessment;
• Severe left heart systolic insufficiency (left ventricular ejection fraction \<30%);
• Cardiogenic shock or haemodynamic instability requiring ventricular assist device therapy within 30 days prior to enrolment;

Sponsors & Collaborators

• Zhicheng Medical Technology (Jiaxing) Co, Ltd: lead
• 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

Central Study Contacts

Zang Rongyue

CONTACT

+8613161963311; zangrongyue@peijiamedical.com

Study Design

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

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: February 6, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share