Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications (OPTI-MIND)
This study is ongoing, but not recruiting participants.
Sponsor:
Guidant Corporation
Information provided by (Responsible Party):
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00976482
First received: September 11, 2009
Last updated: August 31, 2012
Last verified: August 2012
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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 ]
| Estimated Enrollment: | 1730 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | September 2013 |
| Estimated 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 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: | August 31, 2012 |
| 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 May 23, 2013