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

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

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation; Arrhythmias, Cardiac
• Intervention / Treatment: Device: Prolonged telemetric Full Disclosure ECG recording.

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 Type: Interventional
• Enrollment (Anticipated): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium, 1090
    • Recruiting
    • Universitair Ziekenhuis Brussel Centre for Heart- and Vascular diseases
    • Contact: Pedro Brugada, MD PhD; Phone Number: +32 2 477 60 09; Email: chvz@uzbrussel.be
    • Contact: Carlo de Asmundis, MD; Phone Number: +32 2 477 60 09; Email: chvz@uzbrussel.be
• Poland
  • Warsaw, Poland, 04-628
    • Recruiting
    • Institute of Cardiology
    • Sub-Investigator: Zbigniew Jedynak, MD, PhD
  • Warsaw, Poland, 04-073
    • Recruiting
    • Klinika Kardiologii CMKP
    • Contact: Piotr Kułakowski, MD PhD; Phone Number: +48 22 8101738; Email: kulak@kkcmkp.pl
    • Principal Investigator: Sebastian Stec, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Catheter ablation	Device: Prolonged telemetric Full Disclosure ECG recording.; Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days; Other Names: Medicalgorithmics, PocketECG
OTHER: Pacemaker implantation	Device: Prolonged telemetric Full Disclosure ECG recording.; Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days; Other Names: Medicalgorithmics, PocketECG
OTHER: Pharmacotherapy	Device: Prolonged telemetric Full Disclosure ECG recording.; Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days; Other Names: Medicalgorithmics, PocketECG

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institute of Cardiology, Warsaw, Poland

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (ANTICIPATED): March 1, 2014
• Study Completion (ANTICIPATED): March 1, 2014

Study Registration Dates

• First Submitted: December 22, 2010
• First Submitted That Met QC Criteria: December 22, 2010
• First Posted (ESTIMATE): December 23, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): May 7, 2013
• Last Update Submitted That Met QC Criteria: May 6, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: ablation, cardiac arrhythmia, atrial fibrillation, telemonitoring, telemetry
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Unconsciousness; Consciousness Disorders; Atrial Fibrillation; Arrhythmias, Cardiac; Syncope
• Other Study ID Numbers: UDAPOIG.01.03.01-00-068/09-00D