Home
Clinical Trials
Minimally Invasive Versus Con...

Minimally Invasive Versus Conventional Aortic Valve Replacement: a Long Term Registry

NCT ID: NCT02278666

Last Updated: 2023-09-13

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

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2022-12-31

Brief Summary

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

The aim of the present study is to assess in a "real life" case list the outcome of three different surgical approaches for isolated aortic valve surgery in terms of surgery times, morbidity and mortality.

Related Clinical Trials

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

Mini-invasive Approaches to Aortic Surgery

NCT04350697

Surgery Surgical Injury Surgical Procedure, Unspecified +2 more

Conventional Versus Mini-Sternotomy for Aortic Valve Surgery

NCT00221663

Heart Valve Diseases

TERMINATED PHASE2/PHASE3

Aortic Root Enlargement Versus Aortic Root Replacement in the Management of Cases With Small Aortic Root

NCT05167539

Aortic Valve Disease

Association Between Surgical Aortic Valve Replacement and Long-term Outcomes in 50 to 65-year-olds

NCT06782620

Aortic Valve Replacement

Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries

NCT06696560

Rheumatic Heart Disease With Valvulitis

NOT_YET_RECRUITING NA

Detailed Description

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

The study will focus on data recorded and collected from daily clinical treatment of patients undergoing isolated aortic valve replacement due to symptomatic aortic stenosis who consented to the use of their personal data. After surgery patients will be followed up to a minimum of 12 months. In-hospital and follow-up outcomes of the different surgical approaches will be analysed.

Conditions

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

Aortic Valve Surgery

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

PROSPECTIVE

Study Groups

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

upper mini-sternotomy

aortic valve replacement surgery via upper J or T sternotomy (ministernotomy)

aortic valve replacement

Intervention Type PROCEDURE

aortic valve replacement with either biological prosthetic valve or mechanical valve

biological prosthetic valve

Intervention Type DEVICE

aortic valve replacement with either biological prosthetic valve or mechanical valve

Mechanical valve

Intervention Type DEVICE

aortic valve replacement with either biological prosthetic valve or mechanical valve

right mini thoracotomy

aortic valve replacement/repair surgery via right mini thoracotomy

aortic valve replacement

Intervention Type PROCEDURE

aortic valve replacement with either biological prosthetic valve or mechanical valve

biological prosthetic valve

Intervention Type DEVICE

aortic valve replacement with either biological prosthetic valve or mechanical valve

Mechanical valve

Intervention Type DEVICE

aortic valve replacement with either biological prosthetic valve or mechanical valve

conventional sternotomy

aortic valve replacement surgery via conventional full sternotomy

aortic valve replacement

Intervention Type PROCEDURE

aortic valve replacement with either biological prosthetic valve or mechanical valve

biological prosthetic valve

Intervention Type DEVICE

aortic valve replacement with either biological prosthetic valve or mechanical valve

Mechanical valve

Intervention Type DEVICE

aortic valve replacement with either biological prosthetic valve or mechanical valve

Interventions

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

aortic valve replacement

aortic valve replacement with either biological prosthetic valve or mechanical valve

Intervention Type PROCEDURE

biological prosthetic valve

aortic valve replacement with either biological prosthetic valve or mechanical valve

Intervention Type DEVICE

Mechanical valve

aortic valve replacement with either biological prosthetic valve or mechanical valve

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AVR

Eligibility Criteria

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

Inclusion Criteria

* All patients undergoing isolated aortic valve surgery
* Written Informed consent to the use of personal data

Exclusion Criteria

* other associated cardiac surgery
* emergency surgery

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ettore Sansavini Health Science Foundation

OTHER

Sponsor Role collaborator

Maria Cecilia Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elisa Mikus, MD

Role: PRINCIPAL_INVESTIGATOR

Maria Cecilia Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Maria Cecilia Hospital

Cotignola, Ravenna, Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ESREFO21

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Comparison of Sutureless Vs. Standard Biological Prostheses for Surgical Aortic Valve Replacement

NCT03965065 UNKNOWN NA

Cerebral Embolic Load in Patients Undergoing Surgical Aortic Valve Replacement: A Comparison of the Conventional With the Minimized Extracorporeal Circulation Technique Using Transcranial Doppler Ultrasound

NCT02308566 COMPLETED PHASE4

REpositionable Versus BallOOn-expandable Prosthesis for Trans-catheter Aortic Valve Implantation

NCT02668484 COMPLETED NA

Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement

NCT01852552 COMPLETED

Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement

NCT05261204 ENROLLING_BY_INVITATION

Impact of Aortic Annulus Calcification on Long-Term Outcomes Following Transcatheter Aortic Valve Replacement: SAINT-TAVR Calcium Registry

NCT06722066 RECRUITING

Comparison of Early Postoperative Outcomes Between Minimally Invasive Valve Surgery Via Right Thoracotomy and Conventional Valve Surgery Via Sternotomy.

NCT07251660 NOT_YET_RECRUITING NA

Long-term Prognosis and Valve Durability of TAVR

NCT06379386 RECRUITING

Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement

NCT02272621 COMPLETED NA

Antegrade Cerebral Perfusion and Retrograde Inferior Vena Caval Perfusion for Total Aortic Arch Replacement

NCT03607786 UNKNOWN NA

Quality of Life After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement

NCT02726087 COMPLETED NA

Transcatheter Aortic Valve Replacement for Failed Transcatheter Aortic Valve

NCT04500964 COMPLETED

Factors Influencing Morbi-mortality in Right Anterior Minithoracotomy Approch for Aortic Valve Replacement

NCT04455165 COMPLETED

Bioprothetic Valve Versus Mechanical Valve of Bioprothetic Valve Versus Mechanical Valve

NCT06041308 RECRUITING

Myocardial Protection in Minimally Invasive Mitral Valve Surgery

NCT04231903 COMPLETED

Comparison Between Three Types of Stented Pericardial Aortic Valves

NCT01522352 UNKNOWN NA

Mid- and Long-term Outcomes of Custom-made Aortic Devices

NCT05777460 RECRUITING

Aortic Valve Replacement Above the Aortic Annulus (SA-AVR) With the Carpentier-Edwards Magna-Ease Bioprosthesis

NCT03976817 COMPLETED

TAV-in-SAV in Japanese Patients

NCT06826027 ACTIVE_NOT_RECRUITING

Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach

NCT03278418 UNKNOWN NA

Comparing Measurements of the Aortic Valve Taken During Surgery With Those Obtained Before Surgery Using Computed Tomography Scans, in Patients Undergoing Surgical Aortic Valve Replacement

NCT07125469 RECRUITING NA

Outcomes of Surgery of Aortic Valve

NCT04277572 UNKNOWN

Surgical vs Transcatheter Aortic Valve Replacement in Young Patients

NCT06861361 RECRUITING NA

Prospective European Multicenter Study on Aortic Valve Replacement: (E-AVR Registry)

NCT03143361 RECRUITING

Health Status of < 50 Year Old Patients After Surgically Implanted Biological and Mechanical Aortic Valves: a Population-based Retrospective Analysis (2010-2020)

NCT05627973 COMPLETED