REmote MOnitoring of paTiEnts witH pacEmaker or implAntable cardioverteR defibrillaTor

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT06173089
• Lead Sponsor: Semmelweis University Heart and Vascular Center

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-01-30
• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2023-12-07
• Last Update Submitted: 2023-12-07
• Study First Posted: 2023-12-15
• Last Update Posted: 2023-12-15
• Primary Completion: 2025-06-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The composite of all-cause mortality, heart failure events	12 months

Secondary Outcome Measures

Name	Time	Method
cardiovascular mortality	12 months
unscheduled visits	12 months
cardiovascular hospitalization	12 months

Trial Locations

Locations (1)

Semmelweis University - Heart and Vascular Center; 🇭🇺 Budapest, Hungary