Health Condition 1: I446- Other and unspecified fascicular block
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients with a clear indication for permanent pacing according to ESC guidelines for management of conduction disturbances such as symptomatic bradycardia complete atrioventricular block or sinus node dysfunction. Patients should be in sinus rhythm at the time of implantation with no documented history of atrial fibrillation before implantation in medical history ECG Holter or telemetry. Patients should be able to comply with follow up for at least 24 months after implantation and should provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: Patients with history of atrial fibrillation before implantation including permanent or paroxysmal atrial fibrillation documented on ECG Holter or telemetry. Patients with prior pharmacological or interventional treatment for atrial fibrillation such as antiarrhythmic drugs or catheter ablation. Patients unable to comply with long term follow up or follow up visits. Patients with contraindications to pacemaker lead placement at selected pacing sites. Patients participating in another study that could influence the results. Patients with previous cardiac device implantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total cumulative atrial high-rate episode AHRE time defined as the sum of durations of all device detected atrial high rate episodes with individual episode duration greater than 6 minutes expresses in minutes or hoursTimepoint: At baseline, 3 months, 12 months , and 24 months post pacemaker implantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of progression to clinically documented atrial fibrillation confirmed by ECG or HolterTimepoint: Up to 24 months;Device or procedure related complications and all cause mortalityTimepoint: Up to 24 months;Echocardiographic markers including left atrial reservoir strain and volume indexTimepoint: Up to 24 months | — |
Countries
India
Contacts
Kauvery Hospital