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A Clinical Trial of the Use of Remote Heart Rhythm Monitoring With a Smartphone After Cardiac Surgery

NCT ID: NCT05509517

Last Updated: 2023-11-30

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

COMPLETED

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-02

Study Completion Date

2023-09-04

Brief Summary

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The objective of the study is to evaluate the clinical consequences following the detection of postoperative atrial fibrillation or flutter (POAF) using a remote heart rhythm monitoring strategy with a photoplethysmography based smartphone technology in the early postoperative period after discharge.

Detailed Description

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A predefined subgroup analysis of the outcomes described below will be performed in the following subgroups:

* Subjects not on anticoagulation drug therapy (for a planned duration of \>45 days) at discharge.
* Subjects with no history of AF prior to surgery and no POAF lasting \>24h in hospital.
* Subjects with a CHADSVASC score ≥ 4 or a CHADSVASC score ≥ 2 with at least one additional risk factor associated with the risk of developing POAF.

additional risk factors include:

* chronic obstructive pulmonary disease
* sleep apnea
* impaired renal function
* left atrial enlargement
* elevated body mass index
* combined CABG with valve repair or replacement

Conditions

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Atrial Fibrillation and Flutter Atrial Fibrillation Postoperative Complications Arrhythmia

Keywords

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Atrial Fibrillation Digital Health Artificial Intelligence Cardiac Surgery Postoperative atrial fibrillation (POAF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Rhythm monitoring group

Patients randomized to the rhythm monitoring arm will assess their heart rhythm with a photoplethismography (PPG) based smartphone application (FibriCheck™). Measurements are performed three times daily and while experiencing symptoms. The patients start measuring immediately after discharge and continues until the scheduled postoperative consultation with the cardiologist or cardiac surgeon at 21-91days after discharge.

Group Type EXPERIMENTAL

Photoplethysmography based smartphone application for heart rhythm analysis (FibriCheck™)

Intervention Type DIAGNOSTIC_TEST

Heart Rhythm assessment using the FibriCheck™ application with the patient's proprietary smartphone, three times daily, from discharge until follow-up consultation (day 21-91 after discharge).

Usual care

Patients randomized to the rhythm monitoring arm will be discharged without protocol mandated rhythm monitoring. A postoperative consultation is scheduled with the cardiologist or cardiac surgeon at 21-91days after discharge.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Photoplethysmography based smartphone application for heart rhythm analysis (FibriCheck™)

Heart Rhythm assessment using the FibriCheck™ application with the patient's proprietary smartphone, three times daily, from discharge until follow-up consultation (day 21-91 after discharge).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Subject underwent any of (including a combination of) the following surgical procedures during index hospitalization. (coronary artery bypass graft, surgical repair or replacement of a cardiac valve)
* Subject provides informed consent
* Subject understands and agrees to comply with planned study procedures.
* Subject is able to perform heart rhythm measurement using the FibriCheck application at home.

Exclusion Criteria

* Pacemaker dependent heart rhythm
* Permanent AF/Aflutter or AF/Aflutter present at the time of inclusion
* Insufficient cognitive or comprehensive level of Dutch to participate to the trial.
* No smartphone available at home.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospitals Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S64572

Identifier Type: -

Identifier Source: org_study_id