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Smart Monitoring und Artificial Intelligence supported Prediction of Arrhythmic Events

Smart Monitoring und Artificial Intelligence supported Prediction of Arrhythmic Events - SMoKI-PrE

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00029303
Enrollment
400
Registered
2025-03-21
Start date
2023-12-01
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I48

Interventions

Group 1: Continuous electrocardiographic monitoring before and after cardiac surgery

Sponsors

Bayern Innovativ
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

Inclusion criteria: Signed patient consent Sinus rhythm at admission (in a high-resolution 12-lead ECG recording of at least 2 minutes); first-degree AV block, frequent (supra-)ventricular extrasystoles, or (in)complete bundle branch block at admission are permissible Adult patients > 18 years If applicable, chronic therapy with beta-blockers (beta-blockade with heart rate 60-80/min) If applicable, with comorbidities: chronic kidney insufficiency (stage 1 and 2 according to KDIGO classification) heart failure (EF > 35%) arterial hypertension liver limitations stage A and B according to Child-Pugh classification Planned elective first heart surgery: CABG, AVR, MVR, MV repair with or without CABG and with or without thoracic aorta intervention.

Exclusion criteria

Exclusion criteria: ge < 18 years Lack of patient consent Emergency surgery Participation in other clinical studies Implanted permanent pacemaker or ICD Contraindication for beta-blocker use Preoperative antiarrhythmic therapy (except beta-blockers and calcium antagonists) Previous heart surgery Preoperative AV block grade II/III Type 2 diabetes mellitus (DM II) with neurological complications or other polyneuropathies Newly occurring thyroid disease

Design outcomes

Primary

MeasureTime frame
Reliable prediction of common arrhythmias after heart surgery

Secondary

MeasureTime frame
Determination of potential predictive factors for postoperative cardiac arrhythmias through the analysis of: - Preoperative status - Intraoperative parameters - Postoperative course

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026