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Remote Supervision to Decrease Hospitalization Rate

NCT02409225 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2017-07-25

No results posted yet for this study

Summary

Purpose: Home monitoring (HM) services supplied by different manufacturers (St Jude Medical, Biotronik, Medtronic) enables trained medical staff (doctors, electrophysiology nurses and technicians) to safely follow-up patients with implanted ICD/CRT-D remotely, with omitting unnecessary visits in outpatient clinic, shortening time to medical intervention and therefore help to decrease hospitalization rate among those patients.

The RESULT study primary endpoint of the trial will be a composite of all-cause death or hospitalization due to cardiovascular reasons.

The primary technical endpoint is to construct and evaluate a unified and integrated platform for data collected from RM devices manufactured by different companies: Carelink™ (Medtronic®, Minneapolis, MN, USA), Merlin™ (Saint Jude Medical®, St. Paul, MN, USA) and Home Monitoring™ (Biotronik®, Berlin, Germany).

Conditions

Interventions

DEVICE

Home Monitoring

Remote monitoring of ICD/CRT-D function and patient condition allow decreasing costs of treatment of patients with ICD/CRT-D (hospitalization, visits in outpatient clinic) and reducing waiting time for medical intervention (remote or in outpatient clinic).

DEVICE

no Home Monitoring

Patients with ICD/CRT-D devices provided by St Jude Medical, Biotronik or Medtronic with HM option switched off.

Sponsors & Collaborators

  • National Center for Research and Development, Poland

    collaborator OTHER

  • Silesian Centre for Heart Diseases

    lead OTHER

Principal Investigators

  • Lech Polonski, PhD, MD · Silesian Centre for Heart Diseases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02409225 on ClinicalTrials.gov