Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing

Completed

• Conditions: Heart Block; Bradycardia; Sick Sinus Syndrome

• Registration Number: NCT00286858
• Lead Sponsor: Boston Scientific Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-02-02
• Study First Submitted QC: 2006-02-02
• Study First Posted: 2006-02-06
• Study Start: 2006-09
• Primary Completion: 2009-09
• Study Completion: 2010-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 903

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact of Atrio-ventricular hysteresis algorithm on percentage of Ventricular pacing	At 12 Months	% Vp is compared between patients with atrio-ventricular hysteresis algorithm ON and OFF in patients with sino-atrial disease or paroxysmal AV block.

Trial Locations

Locations (40)

CHU de Point à pitre; 🇬🇵 Pointe-a-Pitre, Guadeloupe

Polyclinique Sévigné; 🇫🇷 Cesson Sevigne, France

CH DAX; 🇫🇷 DAX, France

Hôpital Nord; 🇫🇷 Marseille, France

Hôpital de Brabois; 🇫🇷 Vandoeuvre les Nancy, France

Clinique de L'Ormeau; 🇫🇷 Tarbes, France

CHRU- Hôpital Nord; 🇫🇷 Amiens, France

Clinique du Lac et d'Argonay; 🇫🇷 Argonay, France

Clinique Cardiologique Aressy; 🇫🇷 Aressy, France

CH privé St. Martin; 🇫🇷 Caen, France

CH d'Arles; 🇫🇷 Arles, France

Hôpital Fontenoy; 🇫🇷 Chartres, France

Clinique Paulmy; 🇫🇷 Bayonne, France

Polyclinique Bordeaux-Cauderan; 🇫🇷 Bordeaux, France

CHI de Castres; 🇫🇷 Castres, France

CH Beauvais; 🇫🇷 Beauvais, France

Clinique des Cèdres; 🇫🇷 Brive-la-Gaillarde, France

CH Cherbourg; 🇫🇷 Cherbourg, France

Clinique Notre Dame; 🇫🇷 Draguignan, France

CHG de Dinan; 🇫🇷 Dinan, France

CHG Saint Louis - SIH Eure Seine; 🇫🇷 Evreux, France

CHU Albert Michalon; 🇫🇷 Grenoble, France

Polyclinique Louis Pasteur; 🇫🇷 Essey les Nancy, France

CH de La Roche sur Yon; 🇫🇷 La Roche sur Yon, France

Casamance; 🇫🇷 La Ciotat, France

CH Emile Muller; 🇫🇷 Mulhouse, France

CH de Laval; 🇫🇷 Laval, France

Polyclinique du Bois; 🇫🇷 Lille, France

Nouvelles Cliniques Nantaises; 🇫🇷 Nantes, France

Clinique Ambroise Paré; 🇫🇷 Neuilly sur Seine, France

CH Nevers; 🇫🇷 Nevers, France

Clinique A. Brillard; 🇫🇷 Nogent-sur-Marne, France

CHR la Source; 🇫🇷 Orleans, France

CH Maréchal Joffre; 🇫🇷 Perpignan, France

CHU Nîmes; 🇫🇷 Nîmes, France

CHG de Pau; 🇫🇷 Pau, France

CHP de la Loire; 🇫🇷 St. Etienne, France

Clinique St Hilaire; 🇫🇷 Rouen, France

Clinique Belledone; 🇫🇷 St Martin d'Heres, France

Clinique Pasteur; 🇫🇷 Toulouse, France