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

Atrial Fibrillation, Persistent Clinical Trial

Official title:

Personalized Medicine: Home Monitoring as a Tool to Patient Empowerment. Rate Control Self-adjustment in Patients With Permanent or Persistent Atrial Fibrillation Using Cardiovascular Implantable Electronic Device (CIED) Information

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05066971
• Other study ID #: 2019-2913
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: June 15, 2025

Study information

• Verified date: May 2022
• Source: Université de Sherbrooke
• Contact: Felix Alejandro Ayala Paredes, MD PhD
• Phone: +1 819 3461110
• Email: felix.ayala-paredes[@]usherbrooke.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients with permanent or persistent atrial fibrillation require rate control medication to prevent heart rate (HR) speed up. Beta-blockers or calcium channel blockers are used to achieve a reasonable HR; symptoms, EKG and Holter recordings guide clinicians to rate control targets at clinical encounters (at our pacemaker clinic at 6 to 12 months intervals). Once a target HR is achieved, unless new symptoms arise, medication is seldom modified. Rate control medications need to be well adjusted: if not enough dose administered, HR will increase, leading to palpitations, shortness of breath and eventually heart failure; if too much medication is given, patients would experience low cardiac output symptoms (fatigue, tiredness, shortness of breath, low blood pressure, and eventually syncope). Clinicians tend to over control heart rates with no added benefits.

Most of patients with a pacemaker or defibrillator at our center are offered a remote monitoring system as part of a regular follow up schema at our pacemaker clinic; usually to reduce in face encounters, and to be alerted if a problem arises with the pacemaker or defibrillator. There are many remote monitoring systems (five, one for each vendor implanted at our center), and the Home Monitoring® (HM) from Biotronik is specially friendly as all information from the device (pacemaker or defibrillator) is transmitted every day to our clinic with no interaction from the patient side. Beside device status itself (remaining battery, system integrity) daily mean heart rates (measured in beats per minute: bpm) and patient activity (measured as hours per day in activity, as detected by the movement or activity sensor implanted in the device) are also transmitted, but if HR are between safety boundaries (programmed for each patient after implant), all information is rarely used for any other purpose.

If patients with permanent or persistent atrial fibrillation, rate control stable medication, and a HM pacemaker, are followed closely (every week) to adjust the medication (every week if needed, by the research team at the beginning) based on mean heart rates and daily activities already received, we hypothesize that patients will achieve not only better rate control targets, but they will increase their hours of activity per day. Eventually once the patient has understood the principle, medication adjustment would be done by the patient itself based on the same simple information redirected to him or her.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 15, 2025
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with persistent or permanent atrial fibrillation, on rate control medication stable for at least 6 months

• patients with a Biotronik pacemaker connected to HM system

Exclusion Criteria:

• patients with heart failure in need of maximum beta blocker titration

• patients with other indications that would prevent medication adjustment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation, Persistent

Intervention

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.

Locations

Country	Name	City	State
Canada	CHUS Fleurimont	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Chronaki CE, Vardas P. Remote monitoring costs, benefits, and reimbursement: a European perspective. Europace. 2013 Jun;15 Suppl 1:i59-i64. doi: 10.1093/europace/eut110. — View Citation

Slotwiner D, Varma N, Akar JG, Annas G, Beardsall M, Fogel RI, Galizio NO, Glotzer TV, Leahy RA, Love CJ, McLean RC, Mittal S, Morichelli L, Patton KK, Raitt MH, Ricci RP, Rickard J, Schoenfeld MH, Serwer GA, Shea J, Varosy P, Verma A, Yu CM. HRS Expert Consensus Statement on remote interrogation and monitoring for cardiovascular implantable electronic devices. Heart Rhythm. 2015 Jul;12(7):e69-100. doi: 10.1016/j.hrthm.2015.05.008. Epub 2015 May 14. — View Citation

Van Gelder IC, Groenveld HF, Crijns HJ, Tuininga YS, Tijssen JG, Alings AM, Hillege HL, Bergsma-Kadijk JA, Cornel JH, Kamp O, Tukkie R, Bosker HA, Van Veldhuisen DJ, Van den Berg MP; RACE II Investigators. Lenient versus strict rate control in patients with atrial fibrillation. N Engl J Med. 2010 Apr 15;362(15):1363-73. doi: 10.1056/NEJMoa1001337. Epub 2010 Mar 15. — View Citation

Yee R, Verma A, Beardsall M, Fraser J, Philippon F, Exner DV. Canadian Cardiovascular Society/Canadian Heart Rhythm Society joint position statement on the use of remote monitoring for cardiovascular implantable electronic device follow-up. Can J Cardiol. 2013 Jun;29(6):644-51. doi: 10.1016/j.cjca.2012.11.036. Epub 2013 Mar 5. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 minutes walk test	Difference in meters walked between first and last 6 minutes walk test	Baseline, end of the study (12 months after first 6 minute walk test)
Primary	Heart rate control target	Number of weeks where the heart rate is between 80 and 110 beats per minute	Through study completion, up to 1 year
Primary	Physical activity during the day	Percentage of physical activity during the day measured by the pacemaker accelerometer at the end of each week	Through study completion, up to 1 year