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
1 other identifier
interventional
360
2 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable atrial-fibrillation
Started Feb 2011
Typical duration for not_applicable atrial-fibrillation
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2010
CompletedFirst Posted
Study publicly available on registry
December 23, 2010
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedMay 7, 2013
May 1, 2013
3.1 years
December 22, 2010
May 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Therapy efficacy analysis
14 days
Indication for treatment other than catheter ablation
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
Study Arms (3)
Catheter ablation
OTHERPacemaker implantation
OTHERPharmacotherapy
OTHERInterventions
Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Inability to comply with the study protocol
- Lack of patient cooperation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Universitair Ziekenhuis Brussel Centre for Heart- and Vascular diseases
Brussels, 1090, Belgium
Klinika Kardiologii CMKP
Warsaw, 04-073, Poland
Institute of Cardiology
Warsaw, 04-628, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lukasz J Szumowski, MD, PhD
National Institute of Cardiology, Warsaw, Poland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 22, 2010
First Posted
December 23, 2010
Study Start
February 1, 2011
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
May 7, 2013
Record last verified: 2013-05