Telemetric Arrhythmia and Syncope Diagnosis - Evaluation of Arrhythmia Treatment Efficacy

NCT ID: NCT01265303

Last Updated: 2013-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-03-31

Brief Summary

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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

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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

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Atrial Fibrillation Arrhythmias, Cardiac

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Catheter ablation

Group Type OTHER

Prolonged telemetric Full Disclosure ECG recording.

Intervention Type DEVICE

Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days

Pacemaker implantation

Group Type OTHER

Prolonged telemetric Full Disclosure ECG recording.

Intervention Type DEVICE

Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days

Pharmacotherapy

Group Type OTHER

Prolonged telemetric Full Disclosure ECG recording.

Intervention Type DEVICE

Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days

Interventions

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Prolonged telemetric Full Disclosure ECG recording.

Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days

Intervention Type DEVICE

Other Intervention Names

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Medicalgorithmics, PocketECG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Cardiology, Warsaw, Poland

OTHER

Sponsor Role lead

Responsible Party

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Institute of Cardiology, Warsaw Poland

Principal Investigators

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Lukasz J Szumowski, MD, PhD

Role: STUDY_CHAIR

National Institute of Cardiology, Warsaw, Poland

Locations

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Universitair Ziekenhuis Brussel Centre for Heart- and Vascular diseases

Brussels, , Belgium

Site Status RECRUITING

Klinika Kardiologii CMKP

Warsaw, , Poland

Site Status RECRUITING

Institute of Cardiology

Warsaw, , Poland

Site Status RECRUITING

Countries

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Belgium Poland

Central Contacts

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Lukasz Szumowski, MD, PhD

Role: CONTACT

+48501152728

Zbigniew Jedynak, MD, PhD

Role: CONTACT

+48603786780

Facility Contacts

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Pedro Brugada, MD PhD

Role: primary

+32 2 477 60 09

Carlo de Asmundis, MD

Role: backup

+32 2 477 60 09

Piotr Kułakowski, MD PhD

Role: primary

+48 22 8101738

Lukasz Szumowski, Prof,

Role: primary

+48 22 501152728

Other Identifiers

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UDAPOIG.01.03.01-00-068/09-00D

Identifier Type: -

Identifier Source: org_study_id

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