Other Clinical Trial - Cingularbio® Heart Valve Clincial Study

Clinical Trial Description

single arm, 12 month follow up, mutile center, to assess the safety and effectiveness of Cingularbio® heart valve in Aortic Valve Replacement and Mitral Valve Replacement patients ;

Study Design

Related Conditions & MeSH terms

Diseases of Mitral and Aortic Valves

See also
	Status	Clinical Trial	Phase
	Recruiting	`NCT05895487` - Study on Efficacy, Safety and Durability of the UniLine Prosthesis in the Treatment of Aortic and Mitral Valve Disease

See also

Status

Clinical Trial

Phase

Recruiting

NCT05895487 - Study on Efficacy, Safety and Durability of the UniLine Prosthesis in the Treatment of Aortic and Mitral Valve Disease

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT02755220
Study type	Interventional
Source	Shanghai Cingularbio Co. Ltd
Contact
Status	Completed
Phase	N/A
Start date	January 2016
Completion date	April 2019

Cingularbio® Heart Valve Clincial Study

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms