Bradyarrhythmia Clinical Trial
— OPTI-MINDOfficial title:
Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications
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.
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | Katholisches Krankenhaus, St.Johannes Hospital | Hagen |
Lead Sponsor | Collaborator |
---|---|
Guidant Corporation |
Germany,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01089634 -
Left Ventricular Capture Management Study
|
||
Completed |
NCT02930980 -
Micra Accelerometer Sensor Study 2
|
N/A | |
Recruiting |
NCT03693157 -
The Safety and Efficacy of FFR Protocol in NTUH System
|
||
Completed |
NCT05357716 -
Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial
|
||
Recruiting |
NCT05585411 -
PReventive Effect Of Left Bundle Branch Area Pacing Versus righT vEntricular paCing on All Cause deaTh, Heart Failure Progression, and Ventricular dysSYNChrony in Patients With Substantial Ventricular Pacing (PROTECT-SYNC): Multicenter Prospective Randomized Controlled Trial
|
N/A | |
Completed |
NCT01522755 -
Predictive Factors of a Successful Implant of the CapsureFix MRI Model 5086
|
||
Completed |
NCT01513538 -
Analysis of the Acceptance and Changes to Parameters Programming Suggested by the TherapyGuide Function
|
N/A | |
Completed |
NCT05997004 -
Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy
|
N/A | |
Recruiting |
NCT04905199 -
Temporary Transvenous Pacemaker Placement by Intracavitary Electrocardiogram Monitoring
|
||
Recruiting |
NCT05401851 -
Bi-ventricular Epicardial Activation in Left Bundle Area Pacing: a Comparison Study
|
N/A | |
Not yet recruiting |
NCT04437901 -
COVIDAR - Arrhythmias in COVID-19
|
||
Terminated |
NCT01535404 -
Right Versus Left Apical Transvenous Pacing for Patients With Preserved Left Ventricular Systolic Function Study
|
N/A | |
Completed |
NCT01523704 -
Safety and Efficacy Study of IPG Patient With Home Monitoring
|
N/A | |
Recruiting |
NCT06324682 -
ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing
|
||
Completed |
NCT01715558 -
Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications OPTI-MIND 2
|
N/A | |
Recruiting |
NCT01310907 -
Identify the Genes Polymorphisms Related to Non-familial Bradyarrhythmia
|
N/A | |
Recruiting |
NCT04697797 -
Mechanical and Electrical Dyssynchrony During His-Bundle Pacing Versus His-Bundle Area Right Ventricular Pacing
|
||
Recruiting |
NCT04831125 -
Conduction System Pacing International Registry (CONSPIRE)
|
||
Completed |
NCT01897558 -
Myocardial Micro-damage in Relation to Active and Passive Fixation Pacemaker Electrodes
|
N/A |