Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing
This study has been completed.
Sponsor:
Guidant Corporation
Information provided by:
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00286858
First received: February 2, 2006
Last updated: February 25, 2011
Last verified: February 2011
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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 |
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
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:
|
Heart Block Sick Sinus Syndrome Bradycardia Arrhythmias, Cardiac |
Heart Diseases Cardiovascular Diseases Pathologic Processes Arrhythmia, Sinus |
ClinicalTrials.gov processed this record on May 19, 2013