Sinus Node Disease
Conditions
Keywords
Closed Loop Stimulation, Atrial Fibrillation, Stroke, Heart Failure, Pacemaker, ICD
Brief 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.
Detailed description
The benefits of rate-responsiveness on top of dual-chamber pacing still need to be definitively assessed in Sinus Node Dysfunction (SND). Although many rate responsive (RR) sensors have been developed, no large clinical trials evaluated their benefits in terms of clinical endpoints such as clinically relevant atrial fibrillation (AF) and stroke. Electromechanical sensors (piezoelectric accelerometers) have been widely used for their simplicity and overall reliability. However there is some evidence indicating the Closed Loop Stimulation as one of the more efficient and physiological sensors. Two randomized clinical studies have been conducted so far, showing that in the Brady-Tachy Syndrome the CLS algorithm was associated with a significantly lower overall atrial arrhythmia burden as compared both with a DDDR mode based on a standard accelerometric sensor and an atrial overdrive approach. Both studies yielded consistent results, albeit with a parallel and intraindividual comparison designs, respectively. The atrial arrhythmic burden is an important but surrogate endpoint, not necessarily related to long-term clinical outcome. The CLS effects on AF (if any) should be investigated in terms of time to first new onset of clinically relevant AF. In the light of these considerations, it appears interesting to run a large randomized study coherently collecting data on the overall clinical benefit of CLS, primarily in terms of AF and stroke, in a population indicated for pacemaker or ICD and needing dual-chamber pacing due to SND.
Interventions
DEVICEDDD(R)
Device will be programmed in a dual-chamber DDD(R) pacing mode with the Closed Loop Stimulation (CLS) function OFF
DEVICEDDD+CLS
Device will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON
Sponsors
Biotronik SE & Co. KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First event of Sustained Paroxysmal AF or Persistent AF or stroke or TIA, whichever comes first. | three years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Persistent AF | Three years | Assess the date of each events of peristent AF occurred during the follow-up periods |
| Permanent AF | Three years | Assess the date when AF is declared permanent |
| Sustained Paroxysmal AF (SPAF) | Three years | Assess the date of each events of SPAF occurred during the follow-up periods |
| Worsening Heart failure Hospitalization (wHF-H) | Three years | Assess the date of each events of wHF-H occurred during the follow-up periods |
| All cause mortality | Three years | — |
| Stroke/TIA | Three years | Assess the date of each events of stroke/TIA occurred during the follow-up periods |
Countries
China, Hungary, India, Italy, Malaysia, Singapore, South Korea, Spain, Taiwan
Outcome results
None listed