Remote Supervision to Decrease Hospitalization Rate

NCT02409225 | Completed

• 1 other identifier: STRATEGMED1\233221\3\NCBR\2014
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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

Heart Failure

Keywords

remote monitoring; ICD; CRT-D

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of the trial will be composite: death for any reason or hospitalization due to cardiovascular reasons.

  12 months

Secondary Outcomes (7)

• time to medical intervention in case of relevant incidents (arrhythmic, device malfunction, signs heart failure decompensation) in both arms of the study

  12 months

• average number of visits in outpatient clinic (scheduled and unscheduled) per patient

  12 months

• time to first unscheduled visit in outpatient clinic

  12 months

• incidence of inappropriate ICD shocks

  12 months

• proportion of visits in outpatient clinic with relevant findings (necessity of changes of device programming or pharmacological therapy, re-hospitalization, interventions, invasive procedures)

  12 months

Study Arms (2)

Home Monitoring

EXPERIMENTAL

Remote monitoring od ICD/CRT-D function and patient condition. Device: HM provided by St Jude Medical, Biotronik or Medtronic.

Device: Home Monitoring

HM option not active.

ACTIVE COMPARATOR

Regular visits in outpatient clinic. Device: no HM

Device: no Home Monitoring

Interventions

Home Monitoring DEVICE

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).

Home Monitoring

no Home Monitoring DEVICE

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

HM option not active.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years
• EF≤35% prior to implantation
• Period up to 30 days after implantation (ICD/CRT-D) according to ESC guidelines
• Agreement for telemetric supervision
• Informed consent for clinical trial.

You may not qualify if:

• Existence of factors that may cause risk for lack of cooperation in trial regimen (distant residence, mental illness, lack of skills in operating simple electronic devices).
• unavailability of mobile network service in the place of residence/stay.
• Device implanted during intravenous administration of inotropic agents.

Sponsors & Collaborators

• Silesian Centre for Heart Diseases: lead
• National Center for Research and Development, Poland: collaborator

Study Sites (1)

Silesian Centre for Heart Diseases

Zabrze, Silesian Voivodeship, 41-800, Poland

Location

Related Publications (2)

• Tajstra M, Sokal A, Gadula-Gacek E, Kurek A, Wozniak A, Niedziela J, Adamowicz-Czoch E, Rozentryt P, Milewski K, Jachec W, Kalarus Z, Polonski L, Gasior M. Remote Supervision to Decrease Hospitalization Rate (RESULT) study in patients with implanted cardioverter-defibrillator. Europace. 2020 May 1;22(5):769-776. doi: 10.1093/europace/euaa072.

  PMID: 32304216 DERIVED

• Tajstra M, Sokal A, Gwozdz A, Wilczek M, Gacek A, Wojciechowski K, Gadula-Gacek E, Adamowicz-Czoch E, Chlosta-Niepieklo K, Milewski K, Rozentryt P, Kalarus Z, Gasior M, Polonski L. REmote SUpervision to Decrease HospitaLization RaTe. Unified and integrated platform for data collected from devices manufactured by different companies: Design and rationale of the RESULT study. Ann Noninvasive Electrocardiol. 2017 Jul;22(4):e12418. doi: 10.1111/anec.12418. Epub 2016 Dec 25.

  PMID: 28019051 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Lech Polonski, PhD, MD

  Silesian Centre for Heart Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD, MD

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: April 6, 2015
• Study Start: September 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 25, 2017

Record last verified: 2017-07

Locations

PL (1)