Collection of ECG Signals From Various Patient Groups for the Development of Algorithms for Sensing and Detection of Rhythm Anomalies

Biotronik SE & Co. KG5 sites in 1 country89 target enrollmentMarch 10, 2020

ConditionsHeart Diseases Rhythm; Abnormal

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Diseases
Sponsor: Biotronik SE & Co. KG
Enrollment: 89
Locations: 5
Primary Endpoint: Number of Successful ECG Recordings Per Condition
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Collection of Holter surface ECGs for the development of new sensing and detection algorithms

Detailed Description

The aim of the study is to collect data from surface ECGs by using Holter ECG recordings from patients with different forms of diagnosed arrhythmias and/or specific ECG characteristics from heart diseases to support the development of new sensing and detection algorithms for implants.

Registry

clinicaltrials.gov

Start Date

March 10, 2020

End Date

July 14, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biotronik SE & Co. KG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient is able to understand the nature of the study and willing to provide written informed consent.
•Patient is willing and able to attend Holter ECG procedure following a visit
•History of at least one of the following conditions (established via ECG prior to enrollment):
•(A) Patient with pacemaker/ICD and
•Ventricular stimulation \> 30 % or
•(B) Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and at least one of the following:
•Frequent Ventricular Extrasystoles (VES) (incl. Bigeminus) or
•Atrioventricular Reentrant Tachycardia (AVRT)/Wolff-Parkinson-White (WPW) syndrome or
•Atrioventricular Nodal Reentrant Tachycardia (AVNRT) or
•Sinus Tachycardia at rest or

Exclusion Criteria

•Any condition which precludes the patient's ability to comply with the study requirements.
•Known allergy to patch electrodes.
•Pregnant or breast feeding.
•Less than 18 years old.
•Participation in another interventional clinical investigation

Outcomes

Primary Outcomes

Number of Successful ECG Recordings Per Condition

Time Frame: 24 hours

All ECG recordings were evaluated by an internal board and all patients were allocated to one of 15 groups (covering 14 ECG patterns of interest and one group for "no ECG pattern of interest recorded").