Automated Fastener Device Versus Manually Tied Knot in MiAVR
- Conditions
- Heart Valve Diseases
- Registration Number
- NCT03664102
- Lead Sponsor
- Centre Hospitalier La Chartreuse
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 221
- age > 18 years
- Elective patient
- Isolated aortic valve replacement with stented prosthesis
- Minimally-invasive approach (right anterior minithoracotomy)
- Associated procedure
- Aortic valve replacement with sutureless or rapid valve deployment prosthesis
- Active endocarditis
- Prior cardiac surgery
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cardiac surgery times peroperative data Aortic cross-clamping and cardiopulmonary bypass times
- Secondary Outcome Measures
Name Time Method Morbimortality Perioperative (30 days) and 24 months follow up Morbidity (Stroke, pacemaker implantation, aortic regurgitation) Death Valve-related reoperation