REmote MOnitoring of paTiEnts witH pacEmaker or implAntable cardioverteR defibrillaTor

NCT06173089 | Unknown DMC FDA Device

• 1 other identifier: 4279-1/2022
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The composite of all-cause mortality, heart failure events

  12 months

Secondary Outcomes (3)

• cardiovascular mortality

  12 months

• cardiovascular hospitalization

  12 months

• unscheduled visits

  12 months

Other Outcomes (2)

• Change in Kansas City Cardiomyopathy Questionnaire score

  12 months

• change of symptoms (assessed by NYHA classification)

  12 months

Interventions

Remote monitoring DEVICE

Remote monitoring for patients with an ICD/CRT device

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

chronic heart failure with reduced ejection fraction (HFrEF) with an implanted CIED (CRT/ICD) eligible for home monitoring

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Semmelweis University Heart and Vascular Center: lead

Study Sites (1)

Semmelweis University - Heart and Vascular Center

Budapest, 1122, Hungary

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 15, 2023
• Study Start: January 30, 2023
• Primary Completion: June 30, 2025
• Study Completion: August 30, 2025
• Last Updated: December 15, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

HU (1)