Clinical trial NCT01265303: Telemetric Arrhythmia and Syncope Diagnosis - Evaluation of Arrhythmia Treatment Efficacy
Official title: OPTIMIZING DIAGNOSTICS AND THERAPY OF ARRHYTHMIA AND SYNCOPE EVENTS USING INTELLIGENT TELEMETRIC SOLUTIONS - Evaluation of Arrhythmia Treatment Efficacy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Arrhythmias, Cardiac
Keywords: ablation, cardiac arrhythmia, atrial fibrillation, telemonitoring, telemetry
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
First posted: 2010-12-23
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurence of atrial fibrillation
timeFrame: 14 days since the start of monitoring
Secondary outcomes:
measure: Therapy efficacy analysis
timeFrame: 14 days
measure: Indication for treatment other than catheter ablation
timeFrame: 14 days
measure: Correlation of patient self assessment based on the Quality of Life questionnaire and European Heart Rhythm Association (EHRA) scale with cardiac arrhythmia occurrence.
timeFrame: 14 days
measure: Evaluation of stroke and bleeding risk factors incidence based on scores proposed in the European Society of Cardiology (ESC) guidelines: CHADS2VASC2 and HAS-BLED
timeFrame: 14 days
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel Centre for Heart- and Vascular diseases
city: Warsaw
country: Poland
facility: Klinika Kardiologii CMKP
city: Warsaw
country: Poland
facility: Institute of Cardiology
Study officials:
affiliation: National Institute of Cardiology, Warsaw, Poland
name: Lukasz J Szumowski, MD, PhD
role: STUDY_CHAIR
References: