Bradyarrhythmia
Conditions
Keywords
Cardiovascular, Pacemaker, Mortality, Physiologic pacing
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.
Interventions
None listed
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two-year All-cause Mortality | 2 years |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pacemaker Patients currently implanted with permanent Pacemaker according to guidelines | 1,740 |
| Total | 1,740 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Center terminated | 1 |
| Overall Study | Death | 208 |
| Overall Study | Protocol Violation | 5 |
| Overall Study | Withdrawal by Subject | 45 |
Baseline characteristics
| Characteristic | Pacemaker |
|---|---|
| Age, Continuous | 76 years STANDARD_DEVIATION 10 |
| Gender Female | 1047 Participants |
| Gender Male | 693 Participants |
| Primary Indication for Permanent Pacing Atrioventricular Block | 840 participants |
| Primary Indication for Permanent Pacing Neuro-mediated | 61 participants |
| Primary Indication for Permanent Pacing Permanent AF with Slow Ventr. Response | 274 participants |
| Primary Indication for Permanent Pacing sinus node dysfunction | 565 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 206 / 1,740 |
| serious Total, serious adverse events | 611 / 1,740 |
Outcome results
Primary
Two-year All-cause Mortality
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pacemaker | Two-year All-cause Mortality | 11 percentage of participants |