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
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
Treatments tested in this trial
- TAVR Assistance System
- TAVR by manual
Treatment groups
158 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
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