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Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing

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ClinicalTrials.gov Identifier: NCT00286858
Recruitment Status : Completed
First Posted : February 6, 2006
Last Update Posted : January 6, 2016
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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Brief Summary:
This study shall evaluate in daily medical practice the clinical results of the AV delay hysteresis search algorithm in patients with a INSIGNIA ULTRA or AVT pacemaker implanted for one of the three following indications: sinus node dysfunction, atrial disease (or bradycardia/tachycardia) and atrio-ventricular paroxysmal block. In addition use and outcome of automatic functions will be evaluated.

Condition or disease Intervention/treatment
Bradycardia Sick Sinus Syndrome Heart Block Device: Insignia Ultra and Insignia AVT

Study Design
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Study Type : Observational
Actual Enrollment : 903 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Observations of Automatic Algorithms for Cardiac Pacing
Study Start Date : September 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : December 2010

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Groups and Cohorts
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Intervention Details:
  • Device: Insignia Ultra and Insignia AVT
    Regular AV-Delay increase to allow for intrinsic AV conduction, if present.

Outcome Measures
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Primary Outcome Measures :
  1. Impact of Atrio-ventricular hysteresis algorithm on percentage of Ventricular pacing [ Time Frame: At 12 Months ]
    % Vp is compared between patients with atrio-ventricular hysteresis algorithm ON and OFF in patients with sino-atrial disease or paroxysmal AV block.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients with indication for a dual chamber pacemaker and not having a complete AV-block are invited to participate.
Criteria

Inclusion Criteria:

  • Dual chamber pacemaker (INSIGNIA ULTRA or AVT pacemaker), implant not older than 60 days, estimated life expectancy more than one year in case of associated illness, Age ≥ 18 years, signed patient information.

Exclusion Criteria:

  • Indication for conventional treatment with ventricular resynchronisation or by implantable defibrillator during inclusion, implanted for severe permanent AVB (AVB 2/1 and complete), PR > 250 ms, implant of the device older than 60 days before the inclusion date, Heart transplant foreseen within six months, unexplained syncope.
Contacts and Locations
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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): NCT00286858


Locations
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Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Olivier THOMAS, MD Clinique Ambroise Paré
More Information
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00286858    
Other Study ID Numbers: Beluga
First Posted: February 6, 2006    Key Record Dates
Last Update Posted: January 6, 2016
Last Verified: February 2011
Additional relevant MeSH terms:
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Bradycardia
Sick Sinus Syndrome
Heart Block
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Pathologic Processes
Arrhythmia, Sinus
Cardiac Conduction System Disease