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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Institute of Cardiology, Warsaw, Poland
Sponsor:
Information provided by:
Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT01265303
First received: December 22, 2010
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Arrhythmias, Cardiac
Device: Prolonged telemetric Full Disclosure ECG recording.

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: OPTIMIZING DIAGNOSTICS AND THERAPY OF ARRHYTHMIA AND SYNCOPE EVENTS USING INTELLIGENT TELEMETRIC SOLUTIONS - Evaluation of Arrhythmia Treatment Efficacy

Resource links provided by NLM:


Further study details as provided by Institute of Cardiology, Warsaw, Poland:

Primary Outcome Measures:
  • Occurence of atrial fibrillation [ Time Frame: 14 days since the start of monitoring ] [ Designated as safety issue: No ]
    Confirmation of indication for catheter ablation of atrial fibrillation by detection of incidence of AF event during 14 days ECG monitoring


Secondary Outcome Measures:
  • Therapy efficacy analysis [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    The mean atrial fibrillation burden reduction

  • Indication for treatment other than catheter ablation [ Time Frame: 14 days ] [ Designated as safety issue: No ]

    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. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Evaluation of stroke and bleeding risk factors incidence based on scores proposed in the European Society of Cardiology (ESC) guidelines: CHADS2VASC2 and HAS-BLED [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: February 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Catheter ablation Device: Prolonged telemetric Full Disclosure ECG recording.
Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days
Other Name: Medicalgorithmics, PocketECG
Pacemaker implantation Device: Prolonged telemetric Full Disclosure ECG recording.
Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days
Other Name: Medicalgorithmics, PocketECG
Pharmacotherapy Device: Prolonged telemetric Full Disclosure ECG recording.
Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days
Other Name: Medicalgorithmics, PocketECG

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01265303

Contacts
Contact: Lukasz Szumowski, MD, PhD +48501152728 lszumowski@ikard.pl
Contact: Zbigniew Jedynak, MD, PhD +48603786780 zjedynak@ikard.pl

Locations
Belgium
Universitair Ziekenhuis Brussel Centre for Heart- and Vascular diseases Recruiting
Brussel, Belgium, 1090
Contact: Pedro Brugada, MD PhD    +32 2 477 60 09    chvz@uzbrussel.be   
Contact: Carlo de Asmundis, MD    +32 2 477 60 09    chvz@uzbrussel.be   
Principal Investigator: Carlo de Asmundis, MD         
Poland
Institute of Cardiology Recruiting
Warsaw, Poland, 04-628
Contact: Lukasz Szumowski, Prof,    +48 22 501152728    lszumowski@ikard.pl   
Principal Investigator: Lukasz Szumowski, Prof         
Sub-Investigator: Zbigniew Jedynak, MD, PhD         
Klinika Kardiologii CMKP Recruiting
Warsaw, Poland, 04-073
Contact: Piotr Kułakowski, MD PhD    +48 22 8101738    kulak@kkcmkp.pl   
Sub-Investigator: Jakub Baran, MD         
Principal Investigator: Sebastian Stec, MD PhD         
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
Investigators
Study Chair: Lukasz J Szumowski, MD, PhD Institute of Cardiology, Warsaw, Poland
  More Information

No publications provided

Responsible Party: Prof Lukasz Szumowski, Institute of Cardiology, Warsaw Poland
ClinicalTrials.gov Identifier: NCT01265303     History of Changes
Other Study ID Numbers: UDAPOIG.01.03.01-00-068/09-00D
Study First Received: December 22, 2010
Last Updated: May 6, 2013
Health Authority: Poland: Ethics Committee

Keywords provided by Institute of Cardiology, Warsaw, Poland:
ablation, cardiac arrhythmia, atrial fibrillation, telemonitoring, telemetry

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014