Strategy of Early Detection and Active Management of Supraventricular Arrhythmia With Telecardiology (SETAM)
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Purpose
This study investigates if the early detection and treatment of supraventricular arrhythmia (SVA) may help to prevent the progression of the arrhythmia and improve the clinical outcome.
The primary endpoint investigates the delay to implement treatment in two groups of patients :
- Active group: Patients followed by telecardiology.
- Control group: Patients followed in the conventional manner.
It is assumed that the delay to implement treatment will be higher in the Control group.
| Condition | Intervention |
|---|---|
|
Atrial Fibrillation Atrial Flutter Atrial Tachycardia |
Other: Telecardiology |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Investigation on Early Detection and Active Management of Supra-ventricular Arrhythmia With Telecardiology |
- Delay to implement antithrombotic and/or antiarrhythmic drugs for the supraventricular arrhythmia. [ Time Frame: 12-month ] [ Designated as safety issue: No ]Delay from enrollment until the next in-office follow-up during which the supraventricular arrhythmia is managed for the first-time.
- Serious adverse events related to supraventricular arrhythmia. [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]Including : Stroke, systemic embolic event, death, bleeding, and hospitalization for cardiac insufficiency
- Atrial burden at the end of the study [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
- Atrial burden related to time [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]In order to check if atrial burden is time-dependent.
- Supraventricular arrhythmia prevalence [ Time Frame: 12-month ] [ Designated as safety issue: No ]Proportion of patients with supraventricular arrhythmia at the end of the 12-month follow-up.
- Number of patients with managed supraventricular arrhythmia [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]Number of patients with supraventricular arrhythmia and for whom the physician implemented an overall management strategy (antithrombotic and/or antiarrhythmic drugs).
- Supraventricular arrhythmia symptoms score (via a questionnaire) [ Time Frame: at each follow-up visit ] [ Designated as safety issue: Yes ]Questionnaire submitted to the patient at enrollment and at each follow-up visit.
- Quality of Life (via the EQ-5D Questionnaire) [ Time Frame: at each follow-up visit ] [ Designated as safety issue: Yes ]The general health perception of the patients will be asked for, via the standardized EuroQOL EQ-5D questionnaire. This questionnaire provides a descriptive profile covering five dimensions (mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression) as well as a self-rating score of the patient's own assessment of its heath status.
| Estimated Enrollment: | 600 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Active
Patients will be followed by telecardiology.
|
Other: Telecardiology
Telecardiology will be switched on for both groups. For the Active group, all data will be transmitted to the physician. For the Control group, data will not be used for patients surveillance, only events regarding implant (Elective Replacement Indication) or events regarding data transmission missing will be generated and sent to the physician. A retrospective analysis will be performed at the end of the study to compare the results in the two groups. Other Names:
|
|
Active Comparator: Control
Patients will be followed in the conventional manner. They will be equipped with telecardiology but data will not be used for patient surveillance.
|
Other: Telecardiology
Telecardiology will be switched on for both groups. For the Active group, all data will be transmitted to the physician. For the Control group, data will not be used for patients surveillance, only events regarding implant (Elective Replacement Indication) or events regarding data transmission missing will be generated and sent to the physician. A retrospective analysis will be performed at the end of the study to compare the results in the two groups. Other Names:
|
Detailed Description:
Atrial fibrillation is the most commonly encountered sustained cardiac arrhythmia in medical practice and it is often associated with atrial flutter. In patients with the new pacemaker generation EVIA, the home-monitoring technology provides specific and clinical relevant notifications for detection of atrial arrhythmias. Combined with holters memories, this can help to optimize the treatment of supraventricular arrhythmia (SVA) such as atrial fibrillation or flutter.
This study will compare in the two groups the delay to implement for the first time a treatment for the supraventricular arrhythmia (antiarrhythmic drugs and/or an antithrombotic treatment).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Dual chamber pacemaker with activated Telecardiology
- CHAD2DS2-VASc score ≥ 2
- Sinusal rhythm at enrollment
- Patient willing and able to comply with the protocol
- Patient has provided informed consent
- Men and women > 18 years-old
- Patients geographically stable
Exclusion Criteria:
- Anticoagulation therapy
- Dual anti-platelet therapy
- Class I or class III anti-arrhythmic drugs
- Contraindication to antithrombotic therapy
- Participation in another clinical study
- Have a life expectancy < 6 months
Contacts and Locations
Show 57 Study Locations| Principal Investigator: | Walid AMARA, MD | Intercommunal General Hospital in Montfermeil (93370 MONTFERMEIL- FRANCE) |
More Information
No publications provided
| Responsible Party: | Biotronik France |
| ClinicalTrials.gov Identifier: | NCT01108692 History of Changes |
| Other Study ID Numbers: | HS053 |
| Study First Received: | April 21, 2010 |
| Last Updated: | July 3, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Institutional Ethical Committee |
Keywords provided by Biotronik France:
|
atrial fibrillation supraventricular arrhythmia antithrombotic treatment antiarrhythmic drugs medical reaction time |
telecardiology early detection holters memories Pacemaker Telecardiology |
Additional relevant MeSH terms:
|
Arrhythmias, Cardiac Atrial Fibrillation Atrial Flutter Tachycardia Heart Diseases Cardiovascular Diseases |
Pathologic Processes Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013