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Biventricular Tachycardias Outcome Trial

Information source: Sorin Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Biventricular Tachycardias

Intervention: Ovatio CRT 6750 (Device); Ovatio CRT 6750 (Device)

Phase: Phase 4

Status: Completed

Sponsored by: Sorin Group

Official(s) and/or principal investigator(s):
Alexander Bauer, Principal Investigator, Affiliation: Universitätsklinikum Heidelberg, 69120 Heidelberg


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

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.

Clinical Details

Official title: Biventricular Tachycardias Outcome Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome:

Incidence of slow ventricular tachycardias (Slow VTs) in CRT-ICD pts;

ATP therapy efficacy on slow VTs conversion.

Secondary outcome:

Efficacy of ATP therapies on Slow VTs according to therapy setting (delivery in LV only, in RV only, or in LV+RV)

Tvar risk stratification

"unscheduled visits" or "hospital re-admissions" due to slow VTs;

Incidence of adverse events (AEs) in the studied population


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.

Locations and Contacts

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

Additional Information

Starting date: May 2006
Last updated: December 21, 2011

Page last updated: August 23, 2015

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