Open AccessRE mote SU pervision to Decrease HospitaLization RaTe. Unified and integrated platform for data collected from devices manufactured by different companies: Design and rationale of the RESULT study
Author(s) -
Tajstra Mateusz,
Sokal Adam,
Gwóźdź Arkadiusz,
Wilczek Marcin,
Gacek Adam,
Wojciechowski Konrad,
GadulaGacek Elżbieta,
AdamowiczCzoch Elżbieta,
ChłostaNiepiekło Katarzyna,
Milewski Krzysztof,
Rozentryt Piotr,
Kalarus Zbigniew,
Gąsior Mariusz,
Poloński Lech
Publication year - 2017
Publication title -
annals of noninvasive electrocardiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.494
H-Index - 48
eISSN - 1542-474X
pISSN - 1082-720X
DOI - 10.1111/anec.12418
Subject(s) - medicine , clinical endpoint , randomized controlled trial , randomization , clinical trial , emergency medicine , surgery
The number of patients with heart failure implantable cardiac electronic devices ( CIED s) is growing. Hospitalization rate in this group is very high and generates enormous costs. To avoid the need for hospital treatment, optimized monitoring and follow‐up is crucial. Remote monitoring ( RM ) has been widely put into practice in the management of CIED s but it may be difficult due to the presence of differences in systems provided by device manufacturers and loss of gathered data in case of device reimplantation. Additionally, conclusions derived from studies about usefulness of RM in clinical practice apply to devices coming only from a single company. An integrated monitoring platform allows for more comprehensive data analysis and interpretation. Therefore, the primary objective of Remote Supervision to Decrease Hospitalization Rate ( RESULT ) study is to evaluate the impact of RM on the clinical status of patients with ICD s or CRT ‐Ds using an integrated platform. Six hundred consecutive patients with ICD s or CRT ‐Ds implanted will be prospectively randomized to either a traditional or RM ‐based follow‐up model. The primary clinical endpoint will be a composite of all‐cause mortality or hospitalization for cardiovascular reasons within 12 months after randomization. The primary technical endpoint will be to construct and evaluate a unified and integrated platform for the data collected from RM devices manufactured by different companies. This manuscript describes the design and methodology of the prospective, randomized trial designed to determine whether remote monitoring using an integrated platform for different companies is safe, feasible, and efficacious (ClinicalTrials.gov Identifier: NCT 02409225).