Automated Fastener Device Versus Manually Tied Knot in MiAVR

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

221 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-01

Study Completion Date

2018-09-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Multi-center Register for the Use of the Cor-Knot® Automated Knotting System in Heart Valve Surgery

NCT03681834

Vascular Surgery

COMPLETED

ChAracterization of Patients and Treatment OUtcomes in Severe Tricuspid Regurgitation

NCT06838611

Tricuspid Regurgitation Heart Failure Valve Heart Disease

RECRUITING

Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease in Patients Undergoing TAVI

NCT04385459

Aortic Valve Stenosis Coronary Artery Disease

COMPLETED

Early Transcatheter Mitral Valve Repair After Myocardial Infarction

NCT06282042

Acute Mitral Regurgitation

RECRUITING NA

Transcatheter Heart Valve (THV) Sizing and Leakage After Transcatheter Aortic Valve Implantation (TAVI) Before and After Establishing Routine Preprocedure Multi Slice Computerized Tomography (MSCT) Aortic Assessment. A Retrospective Registry Study

NCT02005640

Aortic Stenosis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Valve Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sutures with hand-tied knots

Minimally-invasive isolated aortic valve replacement with Sutures were secured with hand-tied knots

No interventions assigned to this group

Sutures with automated fastener device (Cor-Knot)

Minimally-invasive isolated aortic valve replacement with Sutures were secured with automated fastener device (Cor-Knot)

Cor Knot

Intervention Type DEVICE

Heart valve replacement with or without the use of automated fastener device Cor Knot

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cor Knot

Heart valve replacement with or without the use of automated fastener device Cor Knot

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age \> 18 years
* Elective patient
* Isolated aortic valve replacement with stented prosthesis
* Minimally-invasive approach (right anterior minithoracotomy)