Atrial FibrillationTELEMARC 4NCT01265303
Telemetric Arrhythmia and Syncope Diagnosis - Evaluation of Arrhythmia Treatment Efficacy
A study testing Prolonged telemetric Full Disclosure ECG recording. in people with Atrial Fibrillation and Arrhythmias, Cardiac, run by National Institute of Cardiology, Warsaw, Poland at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Arrhythmias, Cardiac
- What is being tested?
- Prolonged telemetric Full Disclosure ECG recording.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Feb 2011to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Inability to comply with the study protocol
- Lack of patient cooperation
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Poland2 sites, 2 recruiting
- Recruiting
Klinika Kardiologii CMKP
Warsaw, 04-073
Piotr Kułakowski, MD PhD, +48 22 8101738, kulak@kkcmkp.pl
Jakub Baran, MD
- Recruiting
Institute of Cardiology
Warsaw, 04-628
Lukasz Szumowski, Prof,, +48 22 501152728, lszumowski@ikard.pl
Lukasz Szumowski, Prof
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel Centre for Heart- and Vascular diseases
Brussels, 1090
Pedro Brugada, MD PhD, +32 2 477 60 09, chvz@uzbrussel.be
Carlo de Asmundis, MD, +32 2 477 60 09, chvz@uzbrussel.be
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation, Arrhythmias, Cardiac
- Being tested
- Prolonged telemetric Full Disclosure ECG recording.
- Keywords
- ablation, cardiac arrhythmia, atrial fibrillation, telemonitoring, telemetry
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged telemetric Full Disclosure ECG recording.Device
Also called Medicalgorithmics, PocketECG
Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days
| Study group | Role | What they receive |
|---|---|---|
| Catheter ablation | Other | Not described Receives: Device: Prolonged telemetric Full Disclosure ECG recording. |
| Pacemaker implantation | Other | Not described Receives: Device: Prolonged telemetric Full Disclosure ECG recording. |
| Pharmacotherapy | Other | Not described Receives: Device: Prolonged telemetric Full Disclosure ECG recording. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days since the start of monitoring
Secondary outcomes (4)
Therapy efficacy analysis
The mean atrial fibrillation burden reduction
Measured: 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
Measured: 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.
Measured: 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
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startFeb 2011
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Investigators
- Lukasz J Szumowski, MD, PhD, Study chair, National Institute of Cardiology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265303
- Sponsor's protocol ID
- UDAPOIG.01.03.01-00-068/09-00D
- Acronym
- TELEMARC 4
- Status last verified
- May 2013
- First submitted
- 22 Dec 2010
- Last updated
- 7 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIMIZING DIAGNOSTICS AND THERAPY OF ARRHYTHMIA AND SYNCOPE EVENTS USING INTELLIGENT TELEMETRIC SOLUTIONS - Evaluation of Arrhythmia Treatment Efficacy
- ClinicalTrials.gov ID
- NCT01265303
- Acronym / sponsor ID
- TELEMARC 4 / UDAPOIG.01.03.01-00-068/09-00D
- Conditions
- Atrial Fibrillation, Arrhythmias, Cardiac
- Keywords
- ablation, cardiac arrhythmia, atrial fibrillation, telemonitoring, telemetry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 23 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Catheter ablation | Other | Device: Prolonged telemetric Full Disclosure ECG recording. |
| Pacemaker implantation | Other | Device: Prolonged telemetric Full Disclosure ECG recording. |
| Pharmacotherapy | Other | Device: Prolonged telemetric Full Disclosure ECG recording. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Inability to comply with the study protocol
- Lack of patient cooperation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged telemetric Full Disclosure ECG recording.Also: Medicalgorithmics, PocketECGContinuous Full Disclosure Telemetric ECG monitoring lasting 14 days | Device | Catheter ablation, Pacemaker implantation, Pharmacotherapy |
Primary outcome
Occurence of atrial fibrillation
Time frame: 14 days since the start of monitoring
Confirmation of indication for catheter ablation of atrial fibrillation by detection of incidence of AF event during 14 days ECG monitoring
4 secondary outcomes
Therapy efficacy analysis
Time frame: 14 days
Indication for treatment other than catheter ablation
Time frame: 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.
Time frame: 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
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2013.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukasz J Szumowski, MD, PhD study chair
National Institute of Cardiology, Warsaw, Poland
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged telemetric Full Disclosure ECG recording. in people with Atrial Fibrillation and Arrhythmias, Cardiac, run by National Institute of Cardiology, Warsaw, Poland at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lukasz Szumowski, MD, PhD (+48501152728, lszumowski@ikard.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of atrial fibrillation (time frame: 14 days since the start of monitoring). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2013.