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):
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00976482
First received: September 11, 2009
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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
Bradyarrhythmia

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)
Groups/Cohorts
Pacemaker
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient implanted with permanent pacemaker accroding to guidelines.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976482

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

No publications provided

Responsible Party: Guidant Corporation
ClinicalTrials.gov 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:
Cardiovascular
Pacemaker
Mortality
Physiologic pacing

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

ClinicalTrials.gov processed this record on April 16, 2014