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

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ClinicalTrials.gov Identifier: NCT00976482
Recruitment Status : Completed
First Posted : September 14, 2009
Results First Posted : December 2, 2016
Last Update Posted : February 1, 2017
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
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.

Condition or disease

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 1745 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications
Study Start Date : September 2009
Primary Completion Date : September 2013
Study Completion Date : September 2013

Patients currently implanted with permanent Pacemaker according to guidelines

Primary Outcome Measures :
  1. Two-year All-cause Mortality [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient implanted with permanent pacemaker accroding to guidelines.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00976482

Katholisches Krankenhaus, St.Johannes Hospital
Hagen, Germany
Sponsors and Collaborators
Boston Scientific Corporation
Study Chair: Mauro Biffi, MD Az. Osp. S. orsola - Malpighi, Bologna, Italy

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00976482     History of Changes
Other Study ID Numbers: 07-09
First Posted: September 14, 2009    Key Record Dates
Results First Posted: December 2, 2016
Last Update Posted: February 1, 2017
Last Verified: December 2016

Keywords provided by Boston Scientific Corporation:
Physiologic pacing

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes