REmote MOnitoring of paTiEnts witH pacEmaker or implAntable cardioverteR defibrillaTor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-30

Study Completion Date

2025-08-30

Brief Summary

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However, the current guidelines recommend the use of remote monitoring (RM) in patients with cardiac implantable electronic devices (CIED) to reduce inappropriate shocks or early detection of atrial fibrillation, data is incomprehensive on the effectiveness of decreasing heart failure events or mortality in patients with heart failure and reduced ejection fraction (HFrEF). The only randomized trial, which proved the efficacy of RM on mortality was the IN-TIME trial, which used a strict protocol for detection and intervention of the heart failure events.

The primary aim of this study is to optimize the use of remote monitoring system in HFrEF patients already implanted an implantable cardiac defibrillator (ICD) or a cardiac resynchronization therapy (CRT). By creating a high-quality system with structured safety-net, which is able to use the data of remote monitoring messages and alerts of our patients, we can improve their outcome. The primary endpoint is the non-fatal heart failure event or all-cause mortality. Secondary outcomes include all-cause mortality, cardiovascular mortality, heart failure hospitalization, cardiovascular hospitalization, unscheduled visits, af burden, stroke, inappropriate shocks, quality of life, NYHA functional class.

By using artificial intelligence-based methods, the optimal cut-off values of the previously, empirically used alert parameters will be validated or challenged. Additionally, cost-effectiveness to reduce the hospitalizations will be calculated.

Due to this remote monitoring structured safety-net, these patients with severe heart failure can be treated more efficiently, safely and cost-effectively.

Detailed Description

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Conditions

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Heart Failure

Keywords

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remote monitoring home monitoring heart failure cardiac resynchronization therapy implantable cardioverter defibrillator

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Remote monitoring

Remote monitoring for patients with an ICD/CRT device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. CRT-P/CRT-D patients with a feasible device for home monitoring
2. ICD (VVI/VDD/DDD) patients with a feasible device for home monitoring
3. SR/AFib
4. Transmission performance \>80% in the first 2 weeks with new device
5. Informed consent

Exclusion Criteria

1. Life expectancy\<1 year
2. Unable to transmit data
3. Patient is unable to visit the physician/clinic in 12 hours when it is indicated by the alerts
4. Expected non-compliance
5. Pregnancy
6. Known drug, alcohol abuse
7. Participation in other study or HM system concept

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Semmelweis University - Heart and Vascular Center

Budapest, , Hungary

Site Status RECRUITING

Countries

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Hungary

Facility Contacts

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Béla Merkely, PhD,DSc

Role: primary

Annamaria Kosztin, MD,PhD

Role: backup

Other Identifiers

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4279-1/2022

Identifier Type: -

Identifier Source: org_study_id