Study Results
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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COMPLETED
PHASE4
481 participants
INTERVENTIONAL
2006-05-31
2011-11-30
Brief Summary
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The device intended to be used is the OVATIOTM CRT model 6750 but future generation of Sorin Group/ ELA Medical devices may be used provided they are CE marked. Ethics committees and health authorities will be informed prior to any use of a newer device if applicable.
All patients will have a 3-zone detection configuration programmed. The slow VT zone will be defined by programming the detection parameters as follows:
* Slow VT detection rate: 100 bpm (or if the resting rate is higher than 80 bpm, we recommend to adjust this parameter to: resting rate + 30 bpm)
* VT detection rate: 150 bpm
PARAD+ will be the first choice for SVT/ST and VT discrimination in the VT zones.
The Fast VT and VF limits are left to investigator's judgment. Therapy on VT, fast VT and VF are also left to the investigator's judgment.
Patients will be randomized at implant to have the slow VT zone programmed as a monitoring zone (monitoring arm) or to have therapies programmed within the slow VT zone (therapy arm). The randomization table will be generated by Sorin Group/ELA Medical.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Slow VT zone programmed as a "Monitoring" zone (Monitoring arm)
Ovatio CRT 6750
Slow VT zone programmed as a "Monitoring" zone (Monitoring arm)
2
Slow VT zone programmed with ATP therapies (therapy arm).
Ovatio CRT 6750
Slow VT zone programmed with ATP therapies (therapy arm).
Interventions
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Ovatio CRT 6750
Slow VT zone programmed as a "Monitoring" zone (Monitoring arm)
Ovatio CRT 6750
Slow VT zone programmed with ATP therapies (therapy arm).
Eligibility Criteria
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Inclusion Criteria
* Patient has signed a consent form after he/she received the appropriate and mandatory information.
Exclusion Criteria
* Permanent Atrial Fibrillation (AF);
* Any contraindication to the implant or replacement of CRT-ICD;
* Pt is unable to attend the scheduled f-up visits at the implanting Centre;
* Pt is already included in another ongoing clinical study;
* Pt is unable to understand the objectives of the ITAC04 study;
* Pt refuses to cooperate;
* Pt is unable or refuses to provide informed consent;
* Pt is minor (less than 18-year old);
* Pt has life expectancy of less than 1 year;
* Pt is pregnant.
18 Years
ALL
No
Sponsors
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LivaNova
INDUSTRY
Responsible Party
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Universitätsklinikum Heidelberg
Principal Investigators
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Alexander Bauer
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Heidelberg, 69120 Heidelberg
Locations
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Algemeen Ziekenhuis
Antwepen, , Belgium
Grey-Nuns Hospital
Edmonton, , Canada
Royal Alexandra Hospital
Edmonton, , Canada
Laval UH, Ste Foy
Québec, , Canada
CH Albi
Albi, , France
CH Angers
Angers, , France
Hôpital privé d'Antony
Antony, , France
Hôpital Haut Lévèque
Bordeaux, , France
Hôpital de la Cavalle Blanche
Brest, , France
Clinique de Parly II
Le Chesnay, , France
CH St Philibert
Lomme, , France
CHU Hopital La Timone
Marseille, , France
CHU Hôpital Nord - Marseille
Marseille, , France
CHU Hôpital Nord
Marseille, , France
Clinique Beauregard
Marseille, , France
Clinique Clairval
Marseille, , France
Hôpital Arnaud de Villeneu
Montpellier, , France
Clinique Amboise Paré
Neuilly, , France
CHU Hopital Pasteur
Nice, , France
CHU Groupe Carémeau
Nîmes, , France
C.H.R Hopital De La Source
Orléans, , France
Clinique Bizet
Paris, , France
CH Pau
Pau, , France
Hôpital de la Miletrie
Poitiers, , France
CHU Charles Nicolle
Rouen, , France
Centre Cardiologique Du Nord
Saint-Denis, , France
CHU Hôpital Nord
Saint-Etienne, , France
Hopital Font Pré
Toulon, , France
Hôpital Purpan
Toulouse, , France
Herzkreislaufklinik
Bad Bevensen, , Germany
Kerckhoff-Klinik GmbH
Bad Nauheim, , Germany
Praxis Westend
Berlin, , Germany
Universitatsklinik Med. Klinik Heidelberg
Heidelberg, , Germany
Universität des Saarlandes
Homburg, , Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, , Germany
Uniklinik Munster
Münster, , Germany
Krankenhaus Reinbek
Reinbek, , Germany
Ospedale Civile Di Asti
Asti, , Italy
Casa di cura villa pini d'abruzo
Chieti, , Italy
Hospital Clinico
Valencia, , Italy
Hospital Fernando Fonseca
Amadora, , Portugal
CHUVI
Vigo, , Spain
Danderyds Sjukhus Ab
Danderyd, , Sweden
Orebro Universitetssjukhus
Örebro, , Sweden
Royal Bournemouth Hospital
Bournemouth, , United Kingdom
Glenfield Hospital
Leicester, , United Kingdom
St Barts Hospital
London, , United Kingdom
Northern General Hospital
Sheffield, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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Other Identifiers
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BITAC - ITAC04
Identifier Type: -
Identifier Source: org_study_id