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

This study has been completed.
Information provided by (Responsible Party):
Guidant Corporation Identifier:
First received: September 11, 2009
Last updated: March 5, 2014
Last verified: March 2014
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.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications

Further study details as provided by Guidant Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Two-year cardiac cause mortality or first cardiac cause hospitalization according to physiologic pacing setting. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Correlation between physiologic pacing setting and actual programmed pacing parameters. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Clinical development of indications to implantable-cardioverter defibrillator (ICD) or cardiac resynchronization device (CRT), and upgrade to ICD or CRT [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 1740
Study Start Date: September 2009
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Patients currently implanted with permanent Pacemaker according to guidelines

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00976482

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

Responsible Party: Guidant Corporation Identifier: NCT00976482     History of Changes
Other Study ID Numbers: 07-09 
Study First Received: September 11, 2009
Last Updated: March 5, 2014
Health Authority: Austria: Agency for Health and Food Safety
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ministry of Health and Welfare
Italy: Ministry of Health
Netherlands: Dutch Health Care Inspectorate
Portugal: MDD & AIMD INFARMED, Healthcare Products Vigilance Department
Spain: Ministerio de Sanidad y Consumo Direccion General de Farmacia y Productos Sanitarios.
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Guidant Corporation:
Physiologic pacing

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on October 28, 2016