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

NCT ID: NCT00976482

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1745 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-09-30

Brief 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.

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.

Conditions

Bradyarrhythmia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pacemaker

Patients currently implanted with permanent Pacemaker according to guidelines

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mauro Biffi, MD

Role: STUDY_CHAIR

Az. Osp. S. orsola - Malpighi, Bologna, Italy

Locations

Katholisches Krankenhaus, St.Johannes Hospital

Hagen, , Germany

Countries

Germany

Other Identifiers

07-09

Identifier Type: -

Identifier Source: org_study_id