Biventricular Tachycardias Outcome Trial

Phase 4

Completed

• Conditions: Biventricular Tachycardias
• Interventions: Device: Ovatio CRT 6750

• Registration Number: NCT00729235
• Lead Sponsor: LivaNova

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2008-08-04
• Study First Submitted QC: 2008-08-06
• Study First Posted: 2008-08-07
• Primary Completion: 2008-12
• Status Verified: 2010-06
• Study Completion: 2011-11
• Last Update Submitted: 2011-12-21
• Last Update Posted: 2011-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 481

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Ovatio CRT 6750	Slow VT zone programmed with ATP therapies (therapy arm).
1	Ovatio CRT 6750	Slow VT zone programmed as a "Monitoring" zone (Monitoring arm)

Primary Outcome Measures

Name	Time	Method
ATP therapy efficacy on slow VTs conversion.	24 months
Incidence of slow ventricular tachycardias (Slow VTs) in CRT-ICD pts;	24 months

Secondary Outcome Measures

Name	Time	Method
Efficacy of ATP therapies on Slow VTs according to therapy setting (delivery in LV only, in RV only, or in LV+RV)	24 months
Tvar risk stratification	24 months
"unscheduled visits" or "hospital re-admissions" due to slow VTs;	24 months
Incidence of adverse events (AEs) in the studied population	24 months

Trial Locations

Locations (48)

Ospedale Civile Di Asti; 🇮🇹 Asti, Italy

Hospital Clinico; 🇮🇹 Valencia, Italy

Herzkreislaufklinik; 🇩🇪 Bad Bevensen, Germany

C.H.R Hopital De La Source; 🇫🇷 Orléans, France

Hospital Fernando Fonseca; 🇵🇹 Amadora, Portugal

Casa di cura villa pini d'abruzo; 🇮🇹 Chieti, Italy

CHU Hopital Pasteur; 🇫🇷 Nice, France

Kerckhoff-Klinik GmbH; 🇩🇪 Bad Nauheim, Germany

Praxis Westend; 🇩🇪 Berlin, Germany

CHU Groupe Carémeau; 🇫🇷 Nimes, France

Universität des Saarlandes; 🇩🇪 Homburg, Germany

Hôpital Arnaud de Villeneu; 🇫🇷 Montpellier, France

CH Pau; 🇫🇷 Pau, France

Universitatsklinik Med. Klinik Heidelberg; 🇩🇪 Heidelberg, Germany

Royal Bournemouth Hospital; 🇬🇧 Bournemouth, United Kingdom

St Barts Hospital; 🇬🇧 London, United Kingdom

Glenfield Hospital; 🇬🇧 Leicester, United Kingdom

Southampton General Hospital; 🇬🇧 Southampton, United Kingdom

Danderyds Sjukhus Ab; 🇸🇪 Danderyd, Sweden

Orebro Universitetssjukhus; 🇸🇪 Orebro, Sweden

Clinique Bizet; 🇫🇷 Paris, France

Clinique Amboise Paré; 🇫🇷 Neuilly, France

Hôpital de la Miletrie; 🇫🇷 Poitiers, France

Hôpital Purpan; 🇫🇷 Toulouse, France

Centre Cardiologique Du Nord; 🇫🇷 St Denis, France

Hopital Font Pré; 🇫🇷 Toulon, France

Northern General Hospital; 🇬🇧 Sheffield, United Kingdom

Universitätsklinikum Schleswig-Holstein; 🇩🇪 Lübeck, Germany

CHU Hôpital Nord - Marseille; 🇫🇷 Marseille, France

CHU Hopital La Timone; 🇫🇷 Marseille, France

Hôpital de la Cavalle Blanche; 🇫🇷 Brest, France

Clinique de Parly II; 🇫🇷 Le Chesnay, France

CH St Philibert; 🇫🇷 Lomme, France

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

Krankenhaus Reinbek; 🇩🇪 Reinbek, Germany

CHUVI; 🇪🇸 Vigo, Spain

CHU Charles Nicolle; 🇫🇷 Rouen, France

Uniklinik Munster; 🇩🇪 Munster, Germany

CHU Hôpital Nord; 🇫🇷 Saint Etienne, France

Clinique Beauregard; 🇫🇷 Marseille, France

Clinique Clairval; 🇫🇷 Marseille, France