Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications

Bradyarrhythmia Clinical Trial

— OPTI-MIND  

Official title:

Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00976482
• Other study ID #: 07-09
• Status: Completed
• Phase: N/A
• First received: September 11, 2009
• Last updated: March 5, 2014
• Start date: September 2009
• Est. completion date: September 2013

Study information

• Verified date: March 2014
• Source: Guidant Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesGreece: Ministry of Health and WelfareItaly: Ministry of HealthNetherlands: Dutch Health Care InspectoratePortugal: MDD & AIMD INFARMED, Healthcare Products Vigilance DepartmentSpain: Ministerio de Sanidad y Consumo Direccion General de Farmacia y Productos Sanitarios.Switzerland: SwissmedicUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1740
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bradyarrhythmia
• Bradycardia

Locations

Country	Name	City	State
Germany	Katholisches Krankenhaus, St.Johannes Hospital	Hagen

Sponsors (1)

Lead Sponsor	Collaborator
Guidant Corporation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 years	No
Secondary	Two-year cardiac cause mortality or first cardiac cause hospitalization according to physiologic pacing setting.		2 years	No
Secondary	Correlation between physiologic pacing setting and actual programmed pacing parameters.		2 years	No
Secondary	Clinical development of indications to implantable-cardioverter defibrillator (ICD) or cardiac resynchronization device (CRT), and upgrade to ICD or CRT		2 years	No