Telemetric Arrhythmia and Syncope Diagnosis - Evaluation of Arrhythmia Treatment Efficacy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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OPTIMIZING DIAGNOSTICS AND THERAPY OF ARRHYTHMIA AND SYNCOPE EVENTS USING INTELLIGENT TELEMETRIC SOLUTIONS - Evaluation of Arrhythmia Treatment Efficacy

Conditions
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Atrial Fibrillation, Arrhythmias, Cardiac

Intervention / Treatment
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* Device: Prolonged telemetric Full Disclosure ECG recording.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Catheter ablation<br> | Device: Prolonged telemetric Full Disclosure ECG recording.<br>* Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days<br>* Other names: Medicalgorithmics, PocketECG;|
| Other: Pacemaker implantation<br> | Device: Prolonged telemetric Full Disclosure ECG recording.<br>* Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days<br>* Other names: Medicalgorithmics, PocketECG;|
| Other: Pharmacotherapy<br> | Device: Prolonged telemetric Full Disclosure ECG recording.<br>* Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days<br>* Other names: Medicalgorithmics, PocketECG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of atrial fibrillation | Confirmation of indication for catheter ablation of atrial fibrillation by detection of incidence of AF event during 14 days ECG monitoring | 14 days since the start of monitoring | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapy efficacy analysis | The mean atrial fibrillation burden reduction | 14 days | 
| Indication for treatment other than catheter ablation | Confirmation of indication for treatment other than catheter ablation such as: pacemaker or pharmacotherapy by detetion of: arrhythmia other than AF qualifying for treatment Bradycardia < 40 BPM Pauses > 2,5 s on sinus rhythm or > 3,5 on AF | 14 days | 
| Correlation of patient self assessment based on the Quality of Life questionnaire and European Heart Rhythm Association (EHRA) scale with cardiac arrhythmia occurrence. |  | 14 days | 
| Evaluation of stroke and bleeding risk factors incidence based on scores proposed in the European Society of Cardiology (ESC) guidelines: CHADS2VASC2 and HAS-BLED |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ablation, cardiac arrhythmia, atrial fibrillation, telemonitoring, telemetry