Rate Control Self-adjustment in Patients With Permanent or Persistent Atrial Fibrillation Using Device Home Monitoring

NCT05066971 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-05-26

No results posted yet for this study

Summary

Patients with permanent or persistent atrial fibrillation require rate control medication to prevent excessive tachycardia. Since too much medication leads to a lower than expected heart rate (low output and symptoms) and too little leads to a fast heart rate (with associated symptoms), finding the ideal medication level (target that could fluctuate) is vital for patient's wellbeing. Clinicians adjust the medication each time patients come into the clinic (once or twice a year). In between those visits, medication is not changed even though patients would benefit for some incremental medication adjustment.

Patients implanted with Biotronik devices have access to Home Monitoring® (HM), a user friendly remote monitoring system transmitting daily device and patient information to clinicians. Heart rate and activity hours can be tracked and this information could be used to adjust medication.

In a step by step process, patients will gradually gain autonomy in the weekly adjustment of their rate control medication. In order to guide medication adjustment by patients, the research team will filter and simplify the information received by HM before sending it to patients. It is hypothesize that patient empowerment, understanding the dynamics of their heart rates in relation to the amount of medication used, will lead to better heart rate control, and it will improve the daily hours of patients activity.

Conditions

  • Atrial Fibrillation, Persistent

Interventions

COMBINATION_PRODUCT

Self-adjustment of medication

Each week, based on the information provided by HM (heart rate and hours of activity each day), the rate control medication is adjusted to increase the total of activity time.

Sponsors & Collaborators

  • Université de Sherbrooke

    lead OTHER

Principal Investigators

  • Felix Alejandro Ayala Paredes, MD PhD · Sherbrooke university medical school

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2024-06-15
Completion
2025-06-15

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05066971 on ClinicalTrials.gov