This clinical investigation is a device-based open, prospective, multicenter two-arm
randomized trial, comparing patients who are treated in the slow VT zone versus patients who
are not treated in that zone.
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
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.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- Patient has been prescribed the implantation or replacement of a CRT-ICD system
accordingly to the relevant currently-approved ACC/AHA15 (August 2005, Appendix
§M. 10) or ESC 16 (Update 2005, Appendix § M. 11) guidelines or any relevant
currently-approved local guidelines for the implantation or replacement of CRT-ICD.
- Patient has signed a consent form after he/she received the appropriate and mandatory
information.
Exclusion Criteria:
- Clinical history of symptomatic or not symptomatic slow VT;
- 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.
Algemeen Ziekenhuis, Antwepen 2060, Belgium
Grey-Nuns Hospital, Edmonton T5A 0A1, Canada
Royal Alexandra Hospital, Edmonton T5A 0A1, Canada
Laval UH, Ste Foy, Québec G1R 4E4, Canada
CH Albi, Albi, France
CH Angers, Angers 49000, 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 13000, France
CHU Hôpital Nord, Marseille 13000, France
CHU Hôpital Nord - Marseille, Marseille 13000, France
Clinique Beauregard, Marseille 13000, France
Clinique Clairval, Marseille 13000, France
Hôpital Arnaud de Villeneu, Montpellier, France
Clinique Amboise Paré, Neuilly, France
CHU Hopital Pasteur, Nice 6000, France
CHU Groupe Carémeau, Nimes 30000, France
C.H.R Hopital De La Source, Orléans 45000, France
Clinique Bizet, Paris, France
CH Pau, Pau 64000, France
Hôpital de la Miletrie, Poitiers, France
CHU Charles Nicolle, Rouen, France
CHU Hôpital Nord, Saint Etienne 42000, France
Centre Cardiologique Du Nord, St Denis 93200, France
Hopital Font Pré, Toulon 83000, France
Hôpital Purpan, Toulouse, France
Herzkreislaufklinik, Bad Bevensen, Germany
Kerckhoff-Klinik GmbH, Bad Nauheim, Germany
Praxis Westend, Berlin 10871, Germany
Universitatsklinik Med. Klinik Heidelberg, Heidelberg 69118, Germany
Universität des Saarlandes, Homburg, Germany
Universitätsklinikum Schleswig-Holstein, Lübeck, Germany
Uniklinik Munster, Munster, Germany
Krankenhaus Reinbek, Reinbek, Germany
Ospedale Civile Di Asti, Asti 14100, Italy
Casa di cura villa pini d'abruzo, Chieti, Italy
Hospital Clinico, Valencia 46006, Italy
Hospital Fernando Fonseca, Amadora, Portugal
CHUVI, Vigo 36200, Spain
Danderyds Sjukhus Ab, Danderyd 18211, Sweden
Orebro Universitetssjukhus, Orebro 70015, Sweden
Royal Bournemouth Hospital, Bournemouth, United Kingdom
Glenfield Hospital, Leicester LE19, United Kingdom
St Barts Hospital, London, United Kingdom
Northern General Hospital, Sheffield, United Kingdom
Southampton General Hospital, Southampton, United Kingdom