Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing

January 27, 2021 updated by: Boston Scientific Corporation

Clinical Observations of Automatic Algorithms for Cardiac Pacing

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

903

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHRU- Hôpital Nord
      • Aressy, France, 64320
        • Clinique Cardiologique Aressy
      • Argonay, France, 74370
        • Clinique du Lac et d'Argonay
      • Arles, France, 13200
        • CH d'Arles
      • Bayonne, France, 64100
        • Clinique Paulmy
      • Beauvais, France, 60021
        • CH Beauvais
      • Bordeaux, France, 33200
        • Polyclinique Bordeaux-Caudéran
      • Brive-la-Gaillarde, France, 19316
        • Clinique des Cèdres
      • Caen, France, 14050
        • CH privé St. Martin
      • Castres, France, 81100
        • CHI de Castres
      • Cesson Sevigne, France, 35510
        • Polyclinique Sevigné
      • Chartres, France, 28000
        • Hopital Fontenoy
      • Cherbourg, France, 50000
        • CH Cherbourg
      • DAX, France, 40100
        • CH Dax
      • Dinan, France, 22100
        • CHG de Dinan
      • Draguignan, France, 83300
        • Clinique Notre Dame
      • Essey les Nancy, France, 54271
        • Polyclinique Louis Pasteur
      • Evreux, France, 27023
        • CHG Saint Louis - SIH Eure Seine
      • Grenoble, France, 38043
        • CHU Albert Michalon
      • La Ciotat, France, 13600
        • Casamance
      • La Roche sur Yon, France, 85025
        • CH de La Roche sur Yon
      • Laval, France, 53024
        • CH de Laval
      • Lille, France, 59003
        • Polyclinique Du Bois
      • Marseille, France, 13915
        • Hopital Nord
      • Mulhouse, France, 68070
        • CH Emile Muller
      • Nantes, France, 44110
        • Nouvelles Cliniques Nantaises
      • Neuilly sur Seine, France, 92200
        • Clinique Ambroise Paré
      • Nevers, France, 58033
        • CH Nevers
      • Nogent-sur-Marne, France, 94130
        • Clinique A. Brillard
      • Nîmes, France, 30006
        • CHU Nimes
      • Orleans, France, 45067
        • CHR la Source
      • Pau, France, 64046
        • CHG de Pau
      • Perpignan, France, 66046
        • CH Maréchal Joffre
      • Rouen, France, 76000
        • Clinique St Hilaire
      • St Martin d'Heres, France, 38400
        • Clinique Belledone
      • St. Etienne, France, 42000
        • CHP de la Loire
      • Tarbes, France, 65000
        • Clinique de l'Ormeau
      • Toulouse, France, 31076
        • Clinique Pasteur
      • Vandoeuvre les Nancy, France, 54511
        • Hôpital de Brabois
  • Guadeloupe
      • Pointe-a-Pitre, Guadeloupe, 97159
        • CHU de Point à Pitre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Atrio-ventricular hysteresis algorithm on percentage of Ventricular pacing
Time Frame: 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.
At 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Olivier THOMAS, MD, Clinique Ambroise Paré

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

February 2, 2006

First Submitted That Met QC Criteria

February 2, 2006

First Posted (Estimate)

February 6, 2006

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 27, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Beluga

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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