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Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications (OPTI-MIND)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00976482
First received: September 11, 2009
Last updated: December 5, 2016
Last verified: December 2016
September 11, 2009
December 5, 2016
September 2009
September 2013   (Final data collection date for primary outcome measure)
Two-year All-cause Mortality [ Time Frame: 2 years ]
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. [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00976482 on ClinicalTrials.gov Archive Site
Not Provided
  • Two-year cardiac cause mortality or first cardiac cause hospitalization according to physiologic pacing setting. [ Time Frame: 2 years ]
  • Correlation between physiologic pacing setting and actual programmed pacing parameters. [ Time Frame: 2 years ]
  • Clinical development of indications to implantable-cardioverter defibrillator (ICD) or cardiac resynchronization device (CRT), and upgrade to ICD or CRT [ Time Frame: 2 years ]
Not Provided
Not Provided
 
Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications
Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications
The study objective is 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.
The principal objective of the OPTI-MIND study is to collect data on two-year all-cause mortality in a general population implanted with a PM according to current clinical practice. Additionally, the study aims to stratify the outcome by both known patient-related risk factors and by physiologic pacing mode setting (a specifically defined PM programming). Stratification will be done for pre-specified classes of patients on the basis of their primary rhythm disease.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patient implanted with permanent pacemaker accroding to guidelines.
Bradyarrhythmia
Not Provided
Pacemaker
Patients currently implanted with permanent Pacemaker according to guidelines
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1745
September 2013
September 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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;
  • 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;
  • Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

  • Unable to be followed up by the participating centres for a period of two years;
  • Current device implanted for more than 15 days;
  • Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion);
  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00976482
07-09
Yes
Not Provided
Not Provided
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Study Chair: Mauro Biffi, MD Az. Osp. S. orsola - Malpighi, Bologna, Italy
Boston Scientific Corporation
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP