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NCT00286858 Clinical Trial

Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing

Bradycardia Clinical Trial

Official title:
Clinical Observations of Automatic Algorithms for Cardiac Pacing

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00286858
Other study ID # Beluga
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2006
Est. completion date December 2010

Study information
Verified date January 2021
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Insignia Ultra and Insignia AVT
Regular AV-Delay increase to allow for intrinsic AV conduction, if present.
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Sponsors (1)
Lead Sponsor Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

France,  Guadeloupe, 

Outcome
Type Measure Description Time frame Safety issue
Primary Impact of Atrio-ventricular hysteresis algorithm on percentage of Ventricular pacing % Vp is compared between patients with atrio-ventricular hysteresis algorithm ON and OFF in patients with sino-atrial disease or paroxysmal AV block. At 12 Months
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