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Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing

NCT ID: NCT00286858

Last Updated: 2021-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

903 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-09-30

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bradycardia Sick Sinus Syndrome Heart Block

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Insignia Ultra and Insignia AVT

Regular AV-Delay increase to allow for intrinsic AV conduction, if present.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier THOMAS, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Ambroise Paré

Locations

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CHRU- Hôpital Nord

Amiens, , France

Site Status

Clinique Cardiologique Aressy

Aressy, , France

Site Status

Clinique du Lac et d'Argonay

Argonay, , France

Site Status

CH d'Arles

Arles, , France

Site Status

Clinique Paulmy

Bayonne, , France

Site Status

CH Beauvais

Beauvais, , France

Site Status

Polyclinique Bordeaux-Cauderan

Bordeaux, , France

Site Status

Clinique des Cèdres

Brive-la-Gaillarde, , France

Site Status

CH privé St. Martin

Caen, , France

Site Status

CHI de Castres

Castres, , France

Site Status

Polyclinique Sévigné

Cesson-Sévigné, , France

Site Status

Hôpital Fontenoy

Chartres, , France

Site Status

CH Cherbourg

Cherbourg, , France

Site Status

CH DAX

Dax, , France

Site Status

CHG de Dinan

Dinan, , France

Site Status

Clinique Notre Dame

Draguignan, , France

Site Status

Polyclinique Louis Pasteur

Essey-lès-Nancy, , France

Site Status

CHG Saint Louis - SIH Eure Seine

Évreux, , France

Site Status

CHU Albert Michalon

Grenoble, , France

Site Status

Casamance

La Ciotat, , France

Site Status

CH de La Roche sur Yon

La Roche-sur-Yon, , France

Site Status

CH de Laval

Laval, , France

Site Status

Polyclinique du Bois

Lille, , France

Site Status

Hôpital Nord

Marseille, , France

Site Status

CH Emile Muller

Mulhouse, , France

Site Status

Nouvelles Cliniques Nantaises

Nantes, , France

Site Status

Clinique Ambroise Paré

Neuilly-sur-Seine, , France

Site Status

CH Nevers

Nevers, , France

Site Status

CHU Nîmes

Nîmes, , France

Site Status

Clinique A. Brillard

Nogent-sur-Marne, , France

Site Status

CHR la Source

Orléans, , France

Site Status

CHG de Pau

Pau, , France

Site Status

CH Maréchal Joffre

Perpignan, , France

Site Status

Clinique St Hilaire

Rouen, , France

Site Status

CHP de la Loire

Saint-Etienne, , France

Site Status

Clinique Belledone

Saint-Martin-d'Hères, , France

Site Status

Clinique de L'Ormeau

Tarbes, , France

Site Status

Clinique Pasteur

Toulouse, , France

Site Status

Hôpital de Brabois

Vandœuvre-lès-Nancy, , France

Site Status

CHU de Point à pitre

Pointe-à-Pitre, , Guadeloupe

Site Status

Countries

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France Guadeloupe

Other Identifiers

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Beluga

Identifier Type: -

Identifier Source: org_study_id

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