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
• Status: Completed
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 903
• Est. completion date: December 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bradycardia
• Heart Block
• Sick Sinus Syndrome

Intervention

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

Locations

Country	Name	City	State
France	CHRU- Hôpital Nord	Amiens
France	Clinique Cardiologique Aressy	Aressy
France	Clinique du Lac et d'Argonay	Argonay
France	CH d'Arles	Arles
France	Clinique Paulmy	Bayonne
France	CH Beauvais	Beauvais
France	Polyclinique Bordeaux-Cauderan	Bordeaux
France	Clinique des Cèdres	Brive-la-Gaillarde
France	CH privé St. Martin	Caen
France	CHI de Castres	Castres
France	Polyclinique Sévigné	Cesson Sevigne
France	Hôpital Fontenoy	Chartres
France	CH Cherbourg	Cherbourg
France	CH DAX	DAX
France	CHG de Dinan	Dinan
France	Clinique Notre Dame	Draguignan
France	Polyclinique Louis Pasteur	Essey les Nancy
France	CHG Saint Louis - SIH Eure Seine	Evreux
France	CHU Albert Michalon	Grenoble
France	Casamance	La Ciotat
France	CH de La Roche sur Yon	La Roche sur Yon
France	CH de Laval	Laval
France	Polyclinique du Bois	Lille
France	Hôpital Nord	Marseille
France	CH Emile Muller	Mulhouse
France	Nouvelles Cliniques Nantaises	Nantes
France	Clinique Ambroise Paré	Neuilly sur Seine
France	CH Nevers	Nevers
France	CHU Nîmes	Nîmes
France	Clinique A. Brillard	Nogent-sur-Marne
France	CHR la Source	Orleans
France	CHG de Pau	Pau
France	CH Maréchal Joffre	Perpignan
France	Clinique St Hilaire	Rouen
France	Clinique Belledone	St Martin d'Heres
France	CHP de la Loire	St. Etienne
France	Clinique de L'Ormeau	Tarbes
France	Clinique Pasteur	Toulouse
France	Hôpital de Brabois	Vandoeuvre les Nancy
Guadeloupe	CHU de Point à pitre	Pointe-a-Pitre

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