Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications (OPTI-MIND)

Boston Scientific

Status: Completed

Conditions: Bradyarrhythmia

Study type: Observational

Funder types: Industry

Identifiers

NCT00976482

07-09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,745 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,745 participants in 1 patient group

Pacemaker

Description:

Patients currently implanted with permanent Pacemaker according to guidelines