Telemetric Arrhythmia and Syncope Diagnosis - Evaluation of Arrhythmia Treatment Efficacy

Atrial Fibrillation Clinical Trial

— TELEMARC 4  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01265303
• Other study ID #: UDAPOIG.01.03.01-00-068/09-00D
• Status: Recruiting
• Phase: N/A
• First received: December 22, 2010
• Last updated: May 6, 2013
• Start date: February 2011
• Est. completion date: March 2014

Study information

• Verified date: May 2013
• Source: Institute of Cardiology, Warsaw, Poland
• Contact: Lukasz Szumowski, MD, PhD
• Phone: +48501152728
• Email: lszumowski[@]ikard.pl
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation

Intervention

Device:
• Prolonged telemetric Full Disclosure ECG recording.
Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel Centre for Heart- and Vascular diseases	Brussel
Poland	Institute of Cardiology	Warsaw
Poland	Klinika Kardiologii CMKP	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cardiology, Warsaw, Poland

Countries where clinical trial is conducted

Belgium,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Therapy efficacy analysis	The mean atrial fibrillation burden reduction	14 days	No
Secondary	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	No
Secondary	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	No
Secondary	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	No