Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications (OPTI-MIND)
This study has been completed.
Information provided by (Responsible Party):
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.
||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 ]
| Study Start Date:
| Study Completion Date:
| 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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
||March 5, 2014
||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 September 18, 2014