Remote Supervision to Decrease Hospitalization Rate
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

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).
    

Detailed description: 
      The RESULT trial is a prospective, single-center, randomized, open label, parallel study. All
      consecutive patients with symptomatic HF and reduced ejection fraction (≤ 35%) with ICDs or
      CRT-Ds implanted accordingly to current ESC practice guidelines will be prospectively
      randomized in a 1:1 fashion to either a traditional or an RM-based follow-up model. Six
      hundred patients will be enrolled. The inclusion and exclusion criteria are shown in Table 1.
      The clinical status of patients will be estimated using the composite endpoint of all-cause
      death and hospitalization due to cardiovascular reasons. The study protocol has been approved
      by a local ethics committee and complies with the Declaration of Helsinki. A written informed
      consent will be obtained from all study participants. Primary endpoint The primary endpoint
      of the trial will be a composite of all-cause death or hospitalization due to cardiovascular
      reasons. Hospitalization for cardiovascular reasons should consist of:

        -  Hospitalization due to progression of heart failure.

        -  Hospitalization due to persistent arrhythmia (AF, VT).

        -  Hospitalization due to embolic episode.

        -  Hospitalization due to acute coronary syndrome. Every patient will be followed for at
           least 12 months after randomization. Assessment of hospitalization events for
           cardiovascular reasons will be performed according to a recently published consensus
           [13]. The final classification of hospital admissions due to cardiovascular reasons will
           be made by a blinded endpoints committee. 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). Secondary endpoints Both elements combined in the primary endpoint
           will be analyzed separately to estimate their relative impact on the primary endpoint.

      The secondary endpoints include the following:

        -  All-cause death.

        -  Hospitalization due to cardiovascular reasons.

        -  Time to medical intervention in case of relevant incidents (arrhythmic, device
           malfunction, signs of HF decompensation).

        -  Average number of visits to an outpatient clinic (scheduled and unscheduled) per
           patient.

        -  Time to first unscheduled visit in an outpatient clinic.

        -  Incidence of inappropriate ICD shocks.

        -  Proportion of visits to outpatient clinics with relevant findings (necessity of changes
           of device programming or pharmacological therapy, rehospitalization, interventions,
           invasive procedures).

        -  Assessment of quality of life of living study participants according to the Minnesota
           Quality of Life Questionnaire.

        -  Cost-effectiveness, defined as the cost of hospitalizations and/or scheduled and
           unscheduled visits in both groups.

      All consecutive patients after implantation of an ICD or CRT-D manufactured by St.

      Jude Medical, Biotronik or Medtronic will undergo an initial evaluation. Patients who have
      given informed consent and who fulfill the inclusion/exclusion criteria will be screened.
      Randomization to the RM or control group will be conducted within 30 days after ICD or CRT-D
      implantation and after the final programming of sensing and stimulation parameters. The time
      of observation in both groups will be 12 months after randomization. In the RM group only,
      one follow-up visit will be planned 12 months after being enrolled in the trial. In the
      control group, follow-up visits will be planned at 3, 6, 9 and 12 months after being enrolled
      in the trial, according to the normal procedure in our center. Unscheduled visits in both
      groups can be initiated either by the patient or by the supervising staff. The limits of
      therapeutic intervention will be individualized depending on the clinical situation according
      to valid ESC guidelines and will include the following: modification of device settings,
      modification of pharmacotherapy and performing necessary invasive diagnostic and therapeutic
      procedures.
    

Intervention name(s): Home Monitoring; no Home Monitoring
Intervention type(s): Device; Device
Intervention description(s): 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).; Patients with ICD/CRT-D devices provided by St Jude Medical, Biotronik or Medtronic with HM option switched off.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: remote monitoring; ICD; CRT-D