NCT00286858

Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing

Clinical Observations of Automatic Algorithms for Cardiac Pacing

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 903 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bradycardia
• Sick Sinus Syndrome
• Heart Block

Interventions

Type	Name	Description
DEVICE	Insignia Ultra and Insignia AVT	Regular AV-Delay increase to allow for intrinsic AV conduction, if present.

Timeline

• Start date: 2006-09-01
• Primary completion: 2009-09-01
• Completion: 2010-12-01
• First posted: 2006-02-06
• Last updated: 2021-01-28

Locations

40 sites across 2 countries: France, Guadeloupe