Clinical Benefits of the Closed Loop Stimulation in Sinus Node Disease
Megadott ok: Stopping criterion met (N. adjudicated EP1)
Key facts
- Where
- Budapest, MagyarországSee the site
Where in Magyarország
- Semmelweis University - Heart and Vascular CenterBudapest, MagyarországNo longer taking part
Trial details
- Who runs it
- Biotronik SE & Co. KG
- Trial code
- NCT02579889
- Record updated
- 2024. január 18.
- Original description
The study is designed as a multi-center, international, prospective, parallel, randomized, single blinded trial comparing the time to first primary endpoint event (Sustained Paroxysmal AF/Persistent AF or stroke/TIA) occurrence in a follow up period of 3 years, between Closed Loop Stimulation (CLS) ON versus OFF, on top of a DDD pacing in patients with pacemaker or ICD indication who require dual-chamber pacing due to sinus node disease (SND), with or without atrioventricular (AV) block.Read full original descriptionShow less
Clinical Benefits of the Closed Loop Stimulation in Sinus Node Disease - B3 Study
The study is designed as a multi-center, international, prospective, parallel, randomized, single blinded trial comparing the time to first primary endpoint event (Sustained Paroxysmal AF/Persistent AF or stroke/TIA) occurrence in a follow up period of 3 years, between Closed Loop Stimulation (CLS) ON versus OFF, on top of a DDD pacing in patients with pacemaker or ICD indication who require dual-chamber pacing due to sinus node disease (SND), with or without atrioventricular (AV) block.
Inclusion: Patients with Class I or II recommendations for permanent pacing due to SND, with or without AV block according to the current guidelines; Patients for whom dual-chamber pacing is indicated or preferred; Patients with an optimized and stable antiarrhythmic medical therapy at the time of enrolment; Closed Loop Stimulation function was not previously activated; No stroke events from implant; Patient implanted for the first time.
Exclusion: NYHA Class IV Heart Failure; Any indication to Cardiac Resynchronization Therapy (CRT); Atrial fibrillation ablation (left pulmonary veins) or other cardiac surgery < 3 m; Permanent AF (PermAF); Stage V kidney dysfunction; Life expectancy < 1; Minors; Pregnant or breast-feeding patients; Participation in another interventional trial.