Telemetric Arrhythmia and Syncope Diagnosis - Evaluation of Arrhythmia Treatment Efficacy

Not Applicable

• Conditions: Arrhythmias, Cardiac; Atrial Fibrillation
• Interventions: Device: Prolonged telemetric Full Disclosure ECG recording.

• Registration Number: NCT01265303
• Lead Sponsor: National Institute of Cardiology, Warsaw, Poland

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2010-12-22
• Study First Submitted QC: 2010-12-22
• Study First Posted: 2010-12-23
• Study Start: 2011-02
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-06
• Last Update Posted: 2013-05-07
• Primary Completion: 2014-03
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Catheter ablation	Prolonged telemetric Full Disclosure ECG recording.	-
Pacemaker implantation	Prolonged telemetric Full Disclosure ECG recording.	-
Pharmacotherapy	Prolonged telemetric Full Disclosure ECG recording.	-

Primary Outcome Measures

Name	Time	Method
Occurence of atrial fibrillation	14 days since the start of monitoring	Confirmation of indication for catheter ablation of atrial fibrillation by detection of incidence of AF event during 14 days ECG monitoring

Secondary Outcome Measures

Name	Time	Method
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
Indication for treatment other than catheter ablation	14 days	Confirmation of indication for treatment other than catheter ablation such as: pacemaker or pharmacotherapy by detetion of: 1. arrhythmia other than AF qualifying for treatment; 2. Bradycardia \< 40 BPM; 3. Pauses \> 2,5 s on sinus rhythm or \> 3,5 on AF
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
Therapy efficacy analysis	14 days	The mean atrial fibrillation burden reduction

Trial Locations

Locations (3)

Institute of Cardiology; 🇵🇱 Warsaw, Poland

Universitair Ziekenhuis Brussel Centre for Heart- and Vascular diseases; 🇧🇪 Brussel, Belgium

Klinika Kardiologii CMKP; 🇵🇱 Warsaw, Poland