The Occurrence of Atrial Fibrillation After Totally Endoscopic Cardiac Surgery

NCT ID: NCT05633797

Last Updated: 2024-11-29

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

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-22

Study Completion Date

2024-11-09

Brief Summary

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The aim of this study is to investigate the occurrence of new-onset postoperative atrial fibrillation after totally endoscopic cardiac surgery.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Totally endoscopic cardiac surgery

Patients will be monitored using the FibriCheck application to detect atrial fibrillation until 30 days postoperative.

Group Type EXPERIMENTAL

FibriCheck

Intervention Type DEVICE

During the patient's intensive care unit (ICU) stay, they will be monitored constantly to detect atrial fibrillation (standard care). After ICU dismissal, patients will be monitored using the FibriCheck application to detect atrial fibrillation until 30 days postoperative. Patients need to use the FibriCheck application for a minimum of 3x/day and can perform extra measurements when symptoms are present.

Interventions

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FibriCheck

During the patient's intensive care unit (ICU) stay, they will be monitored constantly to detect atrial fibrillation (standard care). After ICU dismissal, patients will be monitored using the FibriCheck application to detect atrial fibrillation until 30 days postoperative. Patients need to use the FibriCheck application for a minimum of 3x/day and can perform extra measurements when symptoms are present.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* \>18 years old
* Patients undergoing elective endoscopic cardiac surgery (totally endoscopic coronary artery bypass grafting or endoscopic valve replacement)

Exclusion Criteria

* Preoperative atrial fibrillation
* Patients that do not understand Dutch or French or English
* Patients that do not have a smartphone
* Concomitant or redo surgeries
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jessa Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alaaddin Yilmaz, MD

Role: PRINCIPAL_INVESTIGATOR

Jessa Hospital

Locations

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Jessa Hospital

Hasselt, Limburg, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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f/2022/127

Identifier Type: -

Identifier Source: org_study_id