Clinical trial NCT00286858: Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing
Official title: Clinical Observations of Automatic Algorithms for Cardiac Pacing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradycardia
Sick Sinus Syndrome
Heart Block
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2006-02-06
Enrollment: 903
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Impact of Atrio-ventricular hysteresis algorithm on percentage of Ventricular pacing
timeFrame: At 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHRU- Hôpital Nord
city: Aressy
country: France
facility: Clinique Cardiologique Aressy
city: Argonay
country: France
facility: Clinique du Lac et d'Argonay
city: Arles
country: France
facility: CH d'Arles
city: Bayonne
country: France
facility: Clinique Paulmy
city: Beauvais
country: France
facility: CH Beauvais
city: Bordeaux
country: France
facility: Polyclinique Bordeaux-Cauderan
city: Brive-la-Gaillarde
country: France
facility: Clinique des Cèdres
city: Caen
country: France
facility: CH privé St. Martin
city: Castres
country: France
facility: CHI de Castres
city: Cesson Sevigne
country: France
facility: Polyclinique Sévigné
city: Chartres
country: France
facility: Hôpital Fontenoy
city: Cherbourg
country: France
facility: CH Cherbourg
city: DAX
country: France
facility: CH DAX
city: Dinan
country: France
facility: CHG de Dinan
city: Draguignan
country: France
facility: Clinique Notre Dame
city: Essey les Nancy
country: France
facility: Polyclinique Louis Pasteur
city: Evreux
country: France
facility: CHG Saint Louis - SIH Eure Seine
city: Grenoble
country: France
facility: CHU Albert Michalon
city: La Ciotat
country: France
facility: Casamance
city: La Roche sur Yon
country: France
facility: CH de La Roche sur Yon
city: Laval
country: France
facility: CH de Laval
city: Lille
country: France
facility: Polyclinique du Bois
city: Marseille
country: France
facility: Hôpital Nord
city: Mulhouse
country: France
facility: CH Emile Muller
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Neuilly sur Seine
country: France
facility: Clinique Ambroise Paré
city: Nevers
country: France
facility: CH Nevers
city: Nogent-sur-Marne
country: France
facility: Clinique A. Brillard
city: Nîmes
country: France
facility: CHU Nîmes
city: Orleans
country: France
facility: CHR la Source
city: Pau
country: France
facility: CHG de Pau
city: Perpignan
country: France
facility: CH Maréchal Joffre
city: Rouen
country: France
facility: Clinique St Hilaire
city: St Martin d'Heres
country: France
facility: Clinique Belledone
city: St. Etienne
country: France
facility: CHP de la Loire
city: Tarbes
country: France
facility: Clinique de L'Ormeau
city: Toulouse
country: France
facility: Clinique Pasteur
city: Vandoeuvre les Nancy
country: France
facility: Hôpital de Brabois
city: Pointe-a-Pitre
country: Guadeloupe
facility: CHU de Point à pitre
Study officials:
affiliation: Clinique Ambroise Paré
name: Olivier THOMAS, MD
role: PRINCIPAL_INVESTIGATOR
References: