Arrhythmia, Sinus
Conditions
Keywords
Sinus Node Disease, Pacemaker, Dual Chamber Pacemaker
Brief summary
Right ventricular apical pacing in patients treated with a pacemaker is unnecessary in cases where patients have stable atrioventricular (AV)-conduction. Recent findings demonstrate that pacing even might have unfavourable effects, especially if patients suffer from additional cardiac diseases such as heart failure. The Search AV+ algorithm was designed to avoid ventricular pacing and support intrinsic AV-conduction in order to avoid possible detrimental effects of right ventricular apical pacing. The goal of the EnTRINSIC study is to assess the amount of ventricular stimulation, the amount of hospitalizations, the occurrence of atrial fibrillation and the usage of drugs in patients treated with pacemakers with an activated Search AV+ algorithm versus patients treated with an individual optimization of the pacemaker settings to minimize the amount of right ventricular pacing.
Interventions
DEVICESearch AV+ algorithm
Sponsors
Medtronic
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with sinus node disease and an intrinsic AV delay of maximal 260 ms * Patients treated with a Medtronic pacemaker with Search AV+ algorithm
Exclusion criteria
* Patients with documented persistent atrial fibrillation within 6 months before implantation and slow AV-conduction * New York Heart Association (NYHA) III/IV * Instable angina pectoris * Heart valve vitium * Persistent AV-block II and III * Early diastolic mitral regurgitation * Implantable cardioverter defibrillator * Participation in other clinical studies * Pregnancy or unreliable birth control * AV-block under strain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of right ventricular pacing | Baseline to 36 months post-implant |
Secondary
| Measure | Time frame |
|---|---|
| Change in intrinsic AV delay | Baseline to 36 months post-implant |
| Hospitalizations because of symptomatic heart failure | Baseline to 36 months post-implant |
| Hospitalizations because of symptomatic atrial fibrillation | Baseline to 36 months post-implant |
| Medication | Baseline to 36 months post-implant |
Countries
Germany
Outcome results
None listed