Telemetric Arrhythmia and Syncope Diagnosis - Evaluation of Arrhythmia Treatment Efficacy (TELEMARC 4)
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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 |
- 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
- 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:
- arrhythmia other than AF qualifying for treatment
- Bradycardia < 40 BPM
- 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 |
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| Contact: Lukasz Szumowski, MD, PhD | +48501152728 | lszumowski@ikard.pl |
| Contact: Zbigniew Jedynak, MD, PhD | +48603786780 | zjedynak@ikard.pl |
| 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 | |
| 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 May 23, 2013