Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications (OPTI-MIND)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: September 11, 2009
Last updated: August 31, 2012
Last verified: August 2012
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications
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 ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2013 (Final data collection date for primary outcome measure)
Patients currently implanted with permanent Pacemaker according to guidelines
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
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patient implanted with permanent pacemaker accroding to guidelines.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976482
|Katholisches Krankenhaus, St.Johannes Hospital
|Hagen, Germany |
||Mauro Biffi, MD
||Az. Osp. S. orsola - Malpighi, Bologna, Italy
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 11, 2009
||August 31, 2012
||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.
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Keywords provided by Guidant Corporation:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2013