Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing
Clinical Observations of Automatic Algorithms for Cardiac Pacing
1 other identifier
observational
903
2 countries
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2006
Longer than P75 for all trials
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2006
CompletedFirst Posted
Study publicly available on registry
February 6, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJanuary 28, 2021
January 1, 2021
3 years
February 2, 2006
January 27, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
Regular AV-Delay increase to allow for intrinsic AV conduction, if present.
Eligibility Criteria
Consecutive patients with indication for a dual chamber pacemaker and not having a complete AV-block are invited to participate.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
CHRU- Hôpital Nord
Amiens, 80054, France
Clinique Cardiologique Aressy
Aressy, 64320, France
Clinique du Lac et d'Argonay
Argonay, 74370, France
CH d'Arles
Arles, 13200, France
Clinique Paulmy
Bayonne, 64100, France
CH Beauvais
Beauvais, 60021, France
Polyclinique Bordeaux-Cauderan
Bordeaux, 33200, France
Clinique des Cèdres
Brive-la-Gaillarde, 19316, France
CH privé St. Martin
Caen, 14050, France
CHI de Castres
Castres, 81100, France
Polyclinique Sévigné
Cesson-Sévigné, 35510, France
Hôpital Fontenoy
Chartres, 28000, France
CH Cherbourg
Cherbourg, 50000, France
CH DAX
Dax, 40100, France
CHG de Dinan
Dinan, 22100, France
Clinique Notre Dame
Draguignan, 83300, France
Polyclinique Louis Pasteur
Essey-lès-Nancy, 54271, France
CHG Saint Louis - SIH Eure Seine
Évreux, 27023, France
CHU Albert Michalon
Grenoble, 38043, France
Casamance
La Ciotat, 13600, France
CH de La Roche sur Yon
La Roche-sur-Yon, 85025, France
CH de Laval
Laval, 53024, France
Polyclinique du Bois
Lille, 59003, France
Hôpital Nord
Marseille, 13915, France
CH Emile Muller
Mulhouse, 68070, France
Nouvelles Cliniques Nantaises
Nantes, 44110, France
Clinique Ambroise Paré
Neuilly-sur-Seine, 92200, France
CH Nevers
Nevers, 58033, France
CHU Nîmes
Nîmes, 30006, France
Clinique A. Brillard
Nogent-sur-Marne, 94130, France
CHR la Source
Orléans, 45067, France
CHG de Pau
Pau, 64046, France
CH Maréchal Joffre
Perpignan, 66046, France
Clinique St Hilaire
Rouen, 76000, France
CHP de la Loire
Saint-Etienne, 42000, France
Clinique Belledone
Saint-Martin-d'Hères, 38400, France
Clinique de L'Ormeau
Tarbes, 65000, France
Clinique Pasteur
Toulouse, 31076, France
Hôpital de Brabois
Vandœuvre-lès-Nancy, 54511, France
CHU de Point à pitre
Pointe-à-Pitre, 97159, Guadeloupe
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivier THOMAS, MD
Clinique Ambroise Paré
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2006
First Posted
February 6, 2006
Study Start
September 1, 2006
Primary Completion
September 1, 2009
Study Completion
December 1, 2010
Last Updated
January 28, 2021
Record last verified: 2021-01