Investigation of the Clinical Performance and Safety of an ECG System Integrated into a Toilet Seat

Investigation of the Clinical Performance and Safety of an ECG System Integrated into a Toilet Seat - Hamberger Heart Study / HHS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035379

Enrollment

120

Registered

2024-10-29

Start date

2024-10-08

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

I48.0 I48.1 I48.2

Interventions

Group 1: Simultaneous measurement with i. ECG seat system ii. Comparator Three trial or test measurements are conducted independently by the subject. One target measurement is performed with a maximum

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Cohort 1: 1. Diagnosed atrial fibrillation (of any type, including paroxysmal, persistent, permanent)* 2. ECG showing atrial fibrillation immediately before study inclusion Cohort 2: No additional criteria *The subject may have other pre-existing heart and circulatory conditions but must disclose them

Exclusion criteria

Exclusion criteria: E-1. Pregnant or breastfeeding women E-2. Previous participation in the KARDIA Pilot Study E-3. Concurrent participation in another clinical study E-4. Presence of a cardiac electronic device E-5. Individuals under the influence of alcohol or drugs E-6. Circulatory problems while sitting E-7. Subject is unable to sit quietly on a toilet for at least 30 seconds. Possible conditions that may prevent this include, but are not limited to: muscular complaints, herniated disc, vertigo, abnormal involuntary movements (tics, Parkinson's) E-8. Psychiatric conditions that hinder the use of the system (e.g., dementia) E-9. Absence or partial amputation of extremities, i.e., contraindications according to ICD-10 codes: Z89.1, Z89.2, Z89.3, Z89.6, Z89.7, Q71.0, Q71.1, Q71.2, Q71.3 E-10. Individuals incapable of giving consent Additional exclusion criteria for Cohort 2: E-11. Diagnosed atrial fibrillation (of any type) or other arrhythmias* *The subject may have other pre-existing heart and circulatory conditions but must disclose them

Design outcomes

Primary

Measure	Time frame
Evidence of the Clinical Performance of the ECG Seat System with Regard to the Automated Detection of Atrial Fibrillation.	—

Secondary

Measure	Time frame
1. Evidence of the Clinical Performance of the ECG Seat System with Regard to the Detection of Atrial Fibrillation by Cardiologists. 2. Determination of the Diagnostic Functionality of the ECG Seat System with Regard to the Automated Detection of Atrial Fibrillation. 3. Determination of the Proportion of Interpretable and App-Classifiable ECGs. 4. Investigation of the Safety of the ECG Seat System.	—

Measure

Time frame

1. Evidence of the Clinical Performance of the ECG Seat System with Regard to the Detection of Atrial Fibrillation by Cardiologists. 2. Determination of the Diagnostic Functionality of the ECG Seat System with Regard to the Automated Detection of Atrial Fibrillation. 3. Determination of the Proportion of Interpretable and App-Classifiable ECGs. 4. Investigation of the Safety of the ECG Seat System.

—

Countries

Germany

Contacts

Public ContactStephan Achenbach

Universitätsklinikum Erlangen, Medizin 2 - Kardiologie und Angiologie

stephan.achenbach@uk-erlangen.de+49 9131 8535301

Outcome results

None listed

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