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

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.

Study Overview

• Status: Completed
• Conditions: Bradyarrhythmia

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.

• Study Type: Observational
• Enrollment (Actual): 1745

Contacts and Locations

Study Locations

• Germany
  • Hagen, Germany
    • Katholisches Krankenhaus, St.Johannes Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient implanted with permanent pacemaker accroding to guidelines.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pacemaker; Patients currently implanted with permanent Pacemaker according to guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Two-year All-cause Mortality	2 years

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Study Chair: Mauro Biffi, MD, Az. Osp. S. orsola - Malpighi, Bologna, Italy

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: September 11, 2009
• First Submitted That Met QC Criteria: September 11, 2009
• First Posted (Estimate): September 14, 2009

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: December 5, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Cardiovascular; Mortality; Pacemaker; Physiologic pacing
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: 07-09