Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing

This study has been completed.
Sponsor:
Information provided by:
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00286858
First received: February 2, 2006
Last updated: February 25, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Bradycardia
Sick Sinus Syndrome
Heart Block
Device: Insignia Ultra and Insignia AVT
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Observations of Automatic Algorithms for Cardiac Pacing

Resource links provided by NLM:


Further study details as provided by Guidant Corporation:

Primary Outcome Measures:
  • Impact of Atrio-ventricular hysteresis algorithm on percentage of Ventricular pacing [ Time Frame: At 12 Months ] [ Designated as safety issue: No ]
    % Vp is compared between patients with atrio-ventricular hysteresis algorithm ON and OFF in patients with sino-atrial disease or paroxysmal AV block.


Enrollment: 903
Study Start Date: September 2006
Study Completion Date: December 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Insignia Ultra and Insignia AVT
    Regular AV-Delay increase to allow for intrinsic AV conduction, if present.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286858

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

No publications provided

Responsible Party: Elisabeth Mouton, Guidant France
ClinicalTrials.gov Identifier: NCT00286858     History of Changes
Other Study ID Numbers: Beluga
Study First Received: February 2, 2006
Last Updated: February 25, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Bradycardia
Heart Block
Sick Sinus Syndrome
Arrhythmia, Sinus
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014