Atrial Fibrillation, Atrial Flutter, Atrial Tachycardia
Conditions
Keywords
atrial fibrillation, supraventricular arrhythmia, antithrombotic treatment, antiarrhythmic drugs, medical reaction time, telecardiology, early detection, holters memories, Pacemaker
Brief summary
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.
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).
Interventions
OTHERTelecardiology
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.
Sponsors
Biotronik SE & Co. KG
Biotronik France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delay to implement antithrombotic and/or antiarrhythmic drugs for the supraventricular arrhythmia. | 12-month | Delay from enrollment until the next in-office follow-up during which the supraventricular arrhythmia is managed for the first-time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Atrial burden at the end of the study | 12-month | — |
| Atrial burden related to time | 12-month | In order to check if atrial burden is time-dependent. |
| Supraventricular arrhythmia prevalence | 12-month | Proportion of patients with supraventricular arrhythmia at the end of the 12-month follow-up. |
| Serious adverse events related to supraventricular arrhythmia. | 12-month | Including : Stroke, systemic embolic event, death, bleeding, and hospitalization for cardiac insufficiency |
| Supraventricular arrhythmia symptoms score (via a questionnaire) | at each follow-up visit | Questionnaire submitted to the patient at enrollment and at each follow-up visit. |
| Quality of Life (via the EQ-5D Questionnaire) | at each follow-up visit | 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. |
| Number of patients with managed supraventricular arrhythmia | 12-month | Number of patients with supraventricular arrhythmia and for whom the physician implemented an overall management strategy (antithrombotic and/or antiarrhythmic drugs). |
Countries
France
Outcome results
None listed