MOnitoring REsynchronization deviCes and cARdiac patiEnts

Study Overview
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Brief Summary
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The objective of this study is to compare two different strategies of disease management in heart failure patients treated with cardiac resynchronization therapy devices Remote monitoring with CareLink Network System Standard management of the disease by means of scheduled routine in-patient follow-ups; and to demonstrate that the remote monitoring strategy is superior to the standard strategy, both in terms of clinical effectiveness and total healthcare system utilization.

Detailed Description
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Major cardiovascular adverse events in patients with heart failure treated with cardiac resynchronization therapy (CRT-D) represent a big concern to the medical community, as they require hospitalizations and may lead to death. Subjects with a history of heart failure are counseled regarding the importance of contacting their clinicians promptly if they experience any changes or worsening of their condition. Acute heart failure episodes with hospitalizations represent one of the most relevant causes of health status deterioration for these patients. Moreover, atrial arrhythmias occurrence is a big issue, as it increases the risk of heart failure itself, stroke and inappropriate shocks. In addition to affecting patient health, hospital admission resulting from these complications will impact healthcare costs. Latest generations of Medtronic CRT-D devices are equipped with a system that triggers an alarm if possible fluid accumulation is detected (OptiVol). This may initiate patient-clinician contact before evident cardiac decompensation. Moreover, advanced diagnostic capabilities for detecting atrial arrhythmias occurrence and total burden are available on such devices. Importantly, all these devices are now able to inform physician of these events by remote monitoring with CareLink Network parameters, and have the potential of playing a key role in patient monitoring. Over the last years, interest has been increasing in remote monitoring models for delivering care to HF patients, either as telemonitoring (transfer of physiological data through telephone or digital cable from home to healthcare provider) or as regular structured telephone contacts between patients and healthcare providers, which may or may not include data transfer. Several studies with relatively large numbers of patients have been published (see table). A recent meta-analysis found that remote monitoring programs for patients with chronic HF living in the community reduced admissions to hospital and all cause mortality by nearly one fifth while improving health related quality of life, but had no significant effect on all cause admission to hospital. However, none of the published studies considered remote monitoring systems able to provide device-detected information on fluid accumulation, AT/AF total burden, arrhythmias occurrence and device-related issues in patients treated with CRT-D devices. Early intervention may then be a key element in avoiding major cardiovascular events to occur and possible deterioration of the disease progression. The Carelink Network remote monitoring system, through Care Alerts, may initiate subject-clinician contact before typical signs and symptoms are exhibited, since it provides the physician with an automatic alert for atrial arrhythmias occurrence, fluid accumulation, and system integrity issues. However, clinical evidence must be provided of the superiority of this patient management strategy with respect to standard clinical practice, based on routine in-office visits. Very recent findings showed that the use of CareLink in European clinical practice is technically feasible and that remote follow-up is an efficient method of surveillance of implanted patients. Moreover, the early detection and review of device and clinical events suggest the potential impact of remote monitoring on overall patient care. There are a number of possible limitations with remote monitoring. The CareLink Network system requires that the patient establishes an initial contact between the device and the remote monitor unit, and that the unit is properly hooked up to the phone line. Not all patients may be able to perform the setup properly. There may be a delay by the physician in consulting patient data (for example over weekends), with a risk of adverse events occurring during that interval. There may be difficulties in contacting patients (e.g. if they are traveling). These possible limitations need to be properly assessed, especially for monitoring atrial arrhythmias, where the time factor is of importance for avoiding complications. Remote patients' disease management has the potential for avoiding hospitalization. Clear demonstration that remote monitoring of AT/AF/HF plus strict treatment guidelines leads to a reduction in hospitalization rates has not been proven, and it could be a major argument for using this technology in routine clinical practice. The MORE-CARE Study is aimed at comparing two different strategies of disease management in heart failure patients treated with CRT-D devices: Remote disease management via Carelink Network system Standard disease management by means of scheduled routine in-patient follow-ups. The main objective of the study is to demonstrate that the remote management strategy is superior to the standard strategy, both in terms of clinical effectiveness and total healthcare system utilization.

Official Title
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MOnitoring REsynchronization deviCes and cARdiac patiEnts

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Medtronic CareLink® Network


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient indicated to CRT-ICD according to current guidelines: Left ventricular systolic dysfunction (LVEF≤35%), New York Heart Association functional class III-IV, QRS≥120 ms Optimized medical treatment. Patient implanted within the last 8 weeks with Medtronic CRT-ICD device equipped with fluid accumulation diagnostics, AT/AF monitoring capability, wireless telemetry for automatic remote data transmission and alerting system for physician. Patient with less than 8 weeks follow-up, who has not received Carelink® Network Monitor and was not managed by Cardiac Compass report reviewing. Carelink Network is available at patient's home Patient or the patient's caregiver is willing and able to use the Medtronic CareLink® Network Monitor and to perform the required duties at home or has a family member or assistant perform those duties. Patient is willing and able to sign an informed consent form. Exclusion Criteria: Inability to fully understand the instructions relating to remote monitoring using CareLink® Network. Permanent AT/AF. Patient had not been previously implanted with a CRT/CRT-D device. Patient has medical conditions that would limit study participation. Patient is less than 18 years of age. Patient is enrolled in or intends to participate in another clinical trial that may have an impact on the study endpoints. Patient meets any exclusion criteria required by local law. Inability or refusal to sign a patient informed consent form. Patient's life expectancy is less than one year in the opinion of the physician Patient is pregnant or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study Group<br>Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity. | Device: Medtronic CareLink® Network<br>* Continuous monitoring via a disease remote management system. Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur.<br>|
| No Intervention: Control Group<br>Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1: Median Time Between Event Onset Time and Clinical Decision for Each Subject. | The median delay from device-detected events to clinical decisions was considerably shorter in the Remote group compared to the Control group | 1 year since the randomization | 
| Phase 2: Combined Endpoint of Death From Any Cause, Cardiovascular and Device-related Hospitalizations (at Least 48 Hours Stay), Calculated as Number of Subjects With at Least One Event | Time to first event | 2 years after randomization |