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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Guidant Corporation
Sponsor:
Information provided by (Responsible Party):
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT01715558
First received: October 15, 2012
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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
Bradyarrhythmia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications

Resource links provided by NLM:


Further study details as provided by Guidant Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Combined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years stratified per patient characteristics. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 500
Study Start Date: February 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
RYTHMIQ study group
Historical control from OPTI-MIND

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715558

Contacts
Contact: Agnes Ramuzat 32 2 4167217 Agnes.Ramuzat@bsci.com
Contact: Luciano Sallusti Luciano.Sallusti@bsci.com

  Show 40 Study Locations
Sponsors and Collaborators
Guidant Corporation
  More Information

No publications provided

Responsible Party: Guidant Corporation
ClinicalTrials.gov Identifier: NCT01715558     History of Changes
Other Study ID Numbers: CDM00053871 / 90942887
Study First Received: October 15, 2012
Last Updated: April 30, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health
Slovakia: State Institute for Drug Control

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

ClinicalTrials.gov processed this record on July 22, 2014