Automated Fastener Device Versus Manually Tied Knot in MiAVR

September 7, 2018 updated by: MORGANT Marie-Catherine, Centre Hospitalier La Chartreuse

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

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

221

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient operated on an Isolated aortic valve replacement with stented prosthesis by Minimally-invasive approach (right anterior minithoracotomy)

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
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

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier La Chartreuse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2009

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 6, 2018

Study Registration Dates

First Submitted

September 6, 2018

First Submitted That Met QC Criteria

September 7, 2018

First Posted (Actual)

September 10, 2018

Study Record Updates

Last Update Posted (Actual)

September 10, 2018

Last Update Submitted That Met QC Criteria

September 7, 2018

Last Verified

September 1, 2018

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)?

No

IPD Plan Description

Trial on medical records only. No specific regulatory authorization required. The trial has already been recorded as Professionnal evaluation practices.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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