Home Monitor for AA Burden Detection IIT in TWN

NCT07572279 | Not Yet Recruiting

• 1 other identifier: 202602039DIPC
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Endpoint:

• Early detection rate in Atrial Arrhythmia (AA) burden
• Data transmission success rate for overall number of atrial burden collection during the monitoring period Secondary Endpoints:
• Atrial burden occurrence at 3/6/12 months post-aATP
• Incidence of arrhythmia
• Safety: Immediate (\< 24 hours), in-hospital, 3 months, 6 months and 12 months adverse events

Conditions

Paroxysmal Atrial Fibrillation (PAF); Atrial Flutter

Keywords

Paroxysmal Atrial Fibrillation; atrial flutter; permanent pacemaker device; Home Monitoring technology

Outcome Measures

Primary Outcomes (1)

• AA burden

  * Early detection rate in Atrial Arrhythmia (AA) burden * Data transmission success rate for overall number of atrial burden collection during the monitoring period

  From enrollment to the end of treatment at 12-16 months (including periods of screen, treatment, and follow-ups)

Secondary Outcomes (1)

• Incidence of arrhythmia

  From enrollment to the end of treatment at 12-16 months (including periods of screen, treatment, and follow-ups)

Study Arms (1)

Diagnosed with Paroxysmal Atrial Fibrillation (PAF) or atrial flutter

W who have been implanted or planned to implant with permanent pacemaker device

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diagnosed with Paroxysmal Atrial Fibrillation (PAF) or atrial flutter who have been implanted or planned to implant with permanent pacemaker device

You may qualify if:

• Adult patients ≥ 20 years of age
• Diagnosed with Paroxysmal Atrial Fibrillation (PAF) or atrial flutter who have been implanted or planned to implant with permanent pacemaker device
• The diagnosis of AF is confirmed on a 12-lead electrocardiogram (ECG) or lasting \>30 seconds in single lead ECG monitor
• Implanted within 12 weeks prior to enrollment or being considered for implantation of a PPM with Home Monitoring technology
• Able to give informed consent for the participation in the trial

You may not qualify if:

• Patients are not able to use CardioMessenger 4G or its successors
• Life expectancy \< 1 year
• Sepsis
• Long-standing Persistent Atrial Fibrillation or Permanent Atrial Fibrillation
• Pregnant or breast-feeding women
• Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints
• Participation in another prospective interventional clinical study within a period of 4 weeks prior to the implantation of Atrial Arrhythmia
• Present or history of drug addiction
• Any other condition that, in the investigator's judgment, might increase the risk to the patients or affect trial quality
• Patients underwent implantable cardioverter-defibrillator implantation

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Biotronik SE & Co. KG: collaborator

Study Sites (1)

National Taiwan University Hospita

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chih-Chieh Yu, MD.PhD

CONTACT

0972652038; sweetchieh@gmail.com

HSIAO-HAN HUANG

CONTACT

0932917553; clrhuang8853@gmail.com

Study Design

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

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 7, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 7, 2026

Record last verified: 2026-04

Locations

TW (1)