Clinical study to collect mid-term clinical outcome in a group of patients implanted with permanent pacemaker (PM) according to real-life clinical practice in a multicenter and international environment.
- Conditions
- Health Condition 1: null- Bradyarrhythmia
- Registration Number
- CTRI/2011/04/001658
- Lead Sponsor
- Guidant Europe a Boston Scientific Company Europe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1730
1. Patients implanted with a current Boston Scientific pacemaker (all ALTRUA models) or any future commercially available Boston Scientific PM families according to international and local guidelines for pacemaker implantation.
2. Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational centre;
3. Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.
1. Unable to be followed up by the participating centres for a period of two years;
2. Current device implanted for more than 15 days;
3. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physicians discretion);
4. Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry or extensions/amendments of the current protocol. Each instance should be brought to the attention of the sponsor to determine eligibility.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Two-year all-cause mortality in patients implanted with PM - overall and stratified per patient characteristics, primary indications for implant, chosen pacing modality and device programming.Timepoint: 2 Years
- Secondary Outcome Measures
Name Time Method All cause hospitalizations according to physiologic pacing setting.Timepoint: 2 Years;Clinical development of indications to implantable-cardioverter defibrillator (ICD) or cardiac resynchronization device (CRT), and upgrade to ICD or CRTTimepoint: 2 Years;Correlation between physiologic pacing setting and actual programmed pacing parameters.Timepoint: 2 Years;Device upgrade to implantable-cardioverter defibrillator (ICD) or cardiac <br/ ><br>resynchronization device (CRT)Timepoint: 2 Years;In the subgroup of patients without atrial fibrillation as primary rhythm disease <br/ ><br>at enrolment: incidence at two years of documented episode of atrial tachycardia or fibrillation.Timepoint: 2 Years;Two-year all-cause mortality according to physiologic pacing settingTimepoint: 2 Years;Two-year cardiac cause mortality or first cardiac cause hospitalization according to physiologic pacing setting. <br/ ><br> <br/ ><br>Timepoint: 2 Years