Trials / Completed
CompletedNCT05509517
A Clinical Trial of the Use of Remote Heart Rhythm Monitoring With a Smartphone After Cardiac Surgery
Remote Heart Rhythm Monitoring Using Photoplethysmography-based Smartphone Technology for the Early Detection of Atrial Fibrillation and Adverse Events After Cardiac Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 450 (actual)
- Sponsor
- Universitaire Ziekenhuizen KU Leuven · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | 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). |
Timeline
- Start date
- 2021-11-02
- Primary completion
- 2023-07-05
- Completion
- 2023-09-04
- First posted
- 2022-08-22
- Last updated
- 2023-11-30
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT05509517. Inclusion in this directory is not an endorsement.