Telemetric Arrhythmia and Syncope Diagnosis - Evaluation of Arrhythmia Treatment Efficacy (TELEMARC 4)

National Institute of Cardiology, Warsaw, Poland

Status: Unknown

Conditions: Atrial Fibrillation; Arrhythmias, Cardiac

Treatments: Device: Prolonged telemetric Full Disclosure ECG recording.

Study type: Interventional

Funder types: Other

Identifiers

NCT01265303

UDAPOIG.01.03.01-00-068/09-00D

Details and patient eligibility

About

The purpose of this study is to assess efficacy of prolonged Full Disclosure ECG monitoring and signal analysis using advanced GSM telemetric technology to prescribe the most appropriate treatment of arrhythmia.

Full description

Non-invasive methods enabling long-term ECG monitoring in patients with paroxysmal symptoms, such as tachycardia or palpitations increase the probability of detecting infrequent but dangerous events with profound clinical significance. Patients with recommendation for the first catheter ablation of Paroxysmal Atrial Fibrillation in the reference center will be included in the study. Eligible patients will have 14-day telemetric ECG monitoring. Based on detected arrhythmia events, patient's medical history and available documentation the most appropriate treatment will be recommended. Patients will undergo invasive procedures of ablation or pacemaker implantation or can be treated pharmacologically. After the invasive treatment or initiation of pharmacotherapy the 14-day telemetric ECG monitoring will be repeated to assess efficacy of the treatment.

Patients with no record of arrhythmia requiring treatment during the first 14 days ECG monitoring will terminate participation in the study. The referring physician will be informed. Further diagnosis or treatment should be performed at the referring physician's center according to the best clinical practice.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age - between 18 and 80 years old
• Physician recommendation for ablation treatment of arrhythmia
• Patient informed consent
• Declarative and feasible compliance (patient understands basic instructions regarding device use)

Exclusion criteria

• Inability to comply with the study protocol
• Lack of patient cooperation

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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360 participants in 3 patient groups

Catheter ablation

Other group

Treatment:

Device: Prolonged telemetric Full Disclosure ECG recording.

Pacemaker implantation

Other group

Treatment:

Device: Prolonged telemetric Full Disclosure ECG recording.

Pharmacotherapy

Other group

Treatment:

Device: Prolonged telemetric Full Disclosure ECG recording.