- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03664102
Automated Fastener Device Versus Manually Tied Knot in MiAVR
Comparison of Automated Fastener Device Versus Manually Tied Knot in Minimally-invasive Isolated Aortic Valve Replacement Surgery
The aim of the investigator's study was to evaluate the efficacy and the safety of the Cor-Knot device in isolated aortic valve replacement (AVR) by right anterior minithoracotomy (RAMT).
Four hundred and forty patients were operated for AVR by RAMT. Of these patients, 221 underwent isolated AVR surgery with stented prosthesis. Sutures were secured using the Cor-Knot titanium fastener in 63 patients and knots were hand-tied in 158.
The aortic cross-clamping and cardiopulmonary bypass times were significantly decreased in the AT group compared with the MT group. Clinical outcomes were similar in the two groups, whether in the analysis of non-matched or matched groups. There was no difference in 30 day-mortality and the stroke and TIA rates were comparable The automated Cor-Knot fastener is an easy-to-use, time-saving device which does not increase perioperative morbi-mortality in patients undergoing AVR by right anterior minithoracotomy.
Study Overview
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- age > 18 years
- Elective patient
- Isolated aortic valve replacement with stented prosthesis
- Minimally-invasive approach (right anterior minithoracotomy)
Exclusion Criteria:
- Associated procedure
- Aortic valve replacement with sutureless or rapid valve deployment prosthesis
- Active endocarditis
- Prior cardiac surgery
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Sutures with hand-tied knots
Minimally-invasive isolated aortic valve replacement with Sutures were secured with hand-tied knots
|
|
Sutures with automated fastener device (Cor-Knot)
Minimally-invasive isolated aortic valve replacement with Sutures were secured with automated fastener device (Cor-Knot)
|
Heart valve replacement with or without the use of automated fastener device Cor Knot
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac surgery times
Time Frame: peroperative data
|
Aortic cross-clamping and cardiopulmonary bypass times
|
peroperative data
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morbimortality
Time Frame: Perioperative (30 days) and 24 months follow up
|
Morbidity (Stroke, pacemaker implantation, aortic regurgitation) Death Valve-related reoperation
|
Perioperative (30 days) and 24 months follow up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCVT-MORGANT 082018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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