TerminatedNot Applicable

Clinical Benefits of the Closed Loop Stimulation in Sinus Node Disease

Stopped: Stopping criterion met (N. adjudicated EP1)

China, Hungary, India1,390 participantsStarted 2015-09

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * Permanent AF (PermAF) * NYHA Class IV Heart Failure * Stage V kidney dysfunction * Any indication to Cardiac Resynchronization Therapy (CRT) * Life expectancy \< 1 * Minors * Pregnant or breast-feeding patients * Participation in another interventional trial * Atrial fibrillation ablation (left pulmonary veins) or other cardiac surgery \< 3 m

What they're measuring

First event of Sustained Paroxysmal AF or Persistent AF or stroke or TIA, whichever comes first.

Timeframe: three years

Trial details

NCT IDNCT02579889

SponsorBiotronik SE & Co. KG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03