Sick Sinus Syndrome
Conditions
Keywords
Cardiac Pacing, artificial, Atrial fibrillation, Pacemaker leads, Lead positions
Brief summary
The purpose of this study is to determine which of 4 lead positions is most effective for pacemaker patients with Sick Sinus Syndrome in order to avoid development of atrial fibrillation.
Detailed description
The incidence of Atrial Fibrillation (AF) in Sick Sinus Syndrome patients treated with pacing is quite high. As AF can cause dizziness, fatigue, thromboembolism and ischemic stroke it is clinically relevant. Due to earlier publications pacing modes and lead placement seem to influence the incidence of AF. In this study the incidence of AF will be compared between 4 different atrial lead positions: 1. Free atrial wall 2. right atrial appendage 3. coronary sinus-os 4. Dual site right atrial pacing: b) plus c). The following primary parameters will be evaluated during the study period of 2 years after implantation: 1. Amounts of AF episodes with a duration of \> 48 hours 2. Amounts of AF episodes with a duration of \> 30 minutes 3. Consultations of physicians due to AF Secondarily, AF burden, Incidence of AF in total, Quality of Life, implant duration and complications will be evaluated.
Interventions
DEVICEPacing leads to be implanted according randomization.
DEVICESelection 9000 prevent AF an Diagnose AF
Sponsors
Vitatron GmbH
Medtronic BRC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sick Sinus Syndrome * Symptomatic sinus bradycardia * Symptomatic SA block * Bradycardia-Tachycardia-Syndrom * Binodal diseases, Sinus Node Syndrome and high degree AV-Block * In case of antiarrhythmic drug therapy: patient must be on a stable dose for at least 3 months before enrollment
Exclusion criteria
* Permanent atrial tachycardia that cannot be transferred into sinus rhythm by drugs or electric cardioversion * Decompensated heart failure * Dilatative cardiomyopathy with an ejection fraction \< 35% * Hypertrophic obstructive cardiomyopathy * Symptomatic hypo- or hyperthyreosis * Myocardial infarction less than 6 months ago * Planned cardiac surgery intervention * Pregnant woman * Patients under 18 years of age * Patients involved in other studies * Patients, already implanted with other (cardiac) leads * Patients with reduced expectancy of life due to other diseases * Patients who are not able to agree in participation of the study * Patients, who cannot attend follow-up visits due to their place of residence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of AF is determined via memory of the pacemaker, which is saved at every follow-up visit at 1 and 10 days after implant and further on at 3, 6, 12, 18 and 24 months after implant. | — |
| 24-Hour ECG and treadmill exercise as well as echocardiography shall be performed before implant and 6, 12 and 24 months after implant | — |
Secondary
| Measure | Time frame |
|---|---|
| Treadmill exercise test as well as echocardiography shall be performed before implant and 6, 12 and 24 month after implant. | — |
| Quality of Life questionnaires are obtained before implant and 12 and 24 months after implants | — |
Countries
Germany
Outcome results
None listed