NCT03068169|Unknown
Biomedical Shirt-based ECG Monitoring
ECG-shirt
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ECG-shirt
Sponsor study identifier
observational
220
1 country
3
Study Start
June 15, 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Cardiovascular diseases (CVD) are associated with high healthcare costs, as well as are a leading cause of mortality and hospitalizations. The main challenge for today's researchers is to develop new technologies, which may help to improve diagnosis of CVD, thereby reducing healthcare costs and quality of patients' lives. Non-invasive wearable electronics offer new capabilities for the diagnosis and management of patients with CVD. Several reports with wearable electronics have been published, in which achieved very positive results with high accuracy. Aim of our study is to show utility of biomedical shirt-based ECG monitoring of patients with CVD in different clinical situations using Nuubo® ECG (nECG) system.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 10, 2017
Actual (reported)March 1, 2017
Actual (reported)June 15, 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Association between early recurrences of atrial tachyarrhythmias (ERAT) during blanking period on long-term effectiveness of pulmonary veins isolation (PVI) using nECG shirt.
Assessment of the rationale for the use of blanking period and to determine whether the early recurrences of atrial tachyarrhythmias (ERAT) burden influences on long-term effectiveness of pulmonary veins isolation (PVI) using nECG shirt. The study might demonstrate which patients with ERAT remain at risk of long-term recurrence of atrial fibrillation (AF).
13 months
Assessment of the usefulness of nECG shirt in detection of fusion and pseudo-fusion beats in cardiac resynchronization therapy (CRT) recipients.
7 months
Assessment of the impact of the use of a pedometer combined with nECG shirt on the level of daily physical activity and its intensity.
12 month
Creation of an algorithm based on nECG monitoring using wearable shirt to differentiate atrioventricular reentry tachycardia (AVRT) with atrioventricular nodal reentry tachycardia (AVNRT) in pediatric patients suffering from supraventricular tachycardia.
1 month
Assessment of the influence of CRT implantation on amount of physical activity measured by nECG shirt.
7 month
The study will be consisted of four independent patient groups: 30 patients with paroxysmal AF treated with PVI; 30 patients scheduled for CRT implantation; 120 patients after early post-infarction ambulatory cardiac rehabilitation; 40 patients, between 5 to 18 years old, with diagnosed SVT and who are qualified for electrophysiological study (EPS).
Department of Pediatric Cardiology and General Pediatrics, Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-091, Poland
Balsam P, Lodzinski P, Tyminska A, Ozieranski K, Januszkiewicz L, Glowczynska R, Wesolowska K, Peller M, Pietrzak R, Ksiazczyk T, Borodzicz S, Koltowski L, Borkowski M, Werner B, Opolski G, Grabowski M. Study design and rationale for biomedical shirt-based electrocardiography monitoring in relevant clinical situations: ECG-shirt study. Cardiol J. 2018;25(1):52-59. doi: 10.5603/CJ.a2017.0102. Epub 2017 Aug 25.
Renata Główczyńska, PhD
1st Department of Cardiology Medical University of Warsaw
Paweł Balsam, PhD
1st Department of Cardiology Medical University of Warsaw
Piotr Lodziński, PhD
1st Department of Cardiology Medical University of Warsaw
Marcin Grabowski, PhD
1st Department of Cardiology Medical University of Warsaw
First Submitted
February 10, 2017
First Posted
March 1, 2017
Study Start
June 15, 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 1, 2018
BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study
Contact the study team to confirm eligibility.
Department of Clinical Nursing, Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-097, Poland
Paweł Balsam
Warsaw, Masovian Voivodeship, 02-097, Poland
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 8, 2017
Record last verified: 2017-06
Data will be available for meta-analysis
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