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Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications OPTI-MIND 2 (OPTI-MIND 2)

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ClinicalTrials.gov Identifier: NCT01715558
Recruitment Status : Completed
First Posted : October 29, 2012
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of the study is to demonstrate that reduction of unnecessary pacing provided by RYTHMIQ algorithm programed to ON in a pacemaker is associated with better clinical outcomes in bradycardia target population.

Condition or disease
Bradyarrhythmia

Study Design

Study Type : Observational
Actual Enrollment : 514 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications
Study Start Date : February 2013
Primary Completion Date : November 2016
Study Completion Date : November 2016
Groups and Cohorts

Group/Cohort
RYTHMIQ study group
Historical control from OPTI-MIND


Outcome Measures

Primary Outcome Measures :
  1. Combined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years in a specific Brady population implanted with BSC PM devices equipped with RYHTMIQ feature [ Time Frame: 2 years ]
    Combined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years in a specific Brady population implanted with BSC PM devices equipped with RYHTMIQ feature compared to data from a cohort of subjects implanted with BSC PM without RYTHMIQ pooled from OPTI-MIND study.


Secondary Outcome Measures :
  1. Combined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years stratified per patient characteristics. [ Time Frame: 2 years ]

    A multivariate model will be used to find the independent association with the combined primary endpoint, RYTHMIQ algorithm and other patient characteristics.

    Variables of interests include (but are not limited to): primary pacing indication (SND vs AVB), degree of AVB, age, gender, underlying disease, use of Betablockers, history of atrial fibrillation, LVEF, NYHA class, RV lead position, type of sensors used.



Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients implanted with permanent pacemaker with RYTHMIQ programed to ON
Criteria

Inclusion Criteria:

  1. Patients implanted with any of BSC dual chamber PM devices equipped with RHYTMIQ with the algorithm programed to ON based on clinical indication at the time of discharge from the hospital
  2. Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center
  3. Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

  1. Patients with 3rd degree AV block
  2. Patients with permanent AF
  3. Patients followed up remotely with remote patient management system.
  4. Patients who are unable to be followed up by the participating centers for a period of two years
  5. Patients who have a current device implanted for more than 15 days
  6. Women of childbearing potential who are pregnant, or plan to become pregnant during the time of the study (method of assessment upon physician's discretion)
  7. 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01715558


  Show 39 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01715558     History of Changes
Other Study ID Numbers: CDM00053871 / 90942887
First Posted: October 29, 2012    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes