N/A N=225

A Retrospective Study to Collect the Data From the Patients Who Had the Perimount Heart Valve Replacement Surgery in China During 2001 to 2007

Mitral Valve or Aortic Valve Replacement

Bottom Line

View on ClinicalTrials.gov: NCT02381678 ↗

Enrolled (actual)

225

Serious AEs

41.8%

Results posted

Oct 2016

Primary outcome: Primary: The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography — 100; 54.54; 26.51; 81.33 Percentage of all subjects

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Perimount 2900/6900 Heart Valve (Device)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.
Primary completion: Nov 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography	100; 54.54; 26.51; 81.33; 62.41; 51.63	—

Summary

The objective of the study is to obtain the clinical data from patients who had the Perimount Heat Valve (Type:6900P and 2900) Replacement Surgery in Guangdong General Hospital during 2001-2007 in order to evaluate the performace of this heart valve prothesis and collect the patients' post-operation infomation including the current living status, mortality rate, and the possibility of re-operation，bleeding and thrombosis. This is a retrospective , observentional clinical study to be conducted in Guangdong General Hospital in China. This study will enroll up to 200 patients.

Eligibility Criteria

Inclusion Criteria

The patients who implanted with Perimount Heart Valve (Type: 6900P and 2900) during 2001-2007 in Guangdong General Hospital in China
The patients agree to join the study and sign the ICF

Exclusion Criteria

No specific exclusion criteria

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02381678). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.