Biventricular Tachycardias Outcome Trial

Condition(s) targeted: Biventricular Tachycardias

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

Phase: Phase 4

Status: Recruiting

Sponsored by: Sorin Group

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

Overall contact:
Alberto Borri, Phone: 39 0161 487 211, Email: Alberto.borri@sorin.com

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.

Official title: Biventricular Tachycardias Outcome Trial

Study design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study

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.

Criteria:

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.

Alberto Borri, Phone: 39 0161 487 211, Email: Alberto.borri@sorin.com

Hôpital privé d'Antony, Antony, France; Recruiting
Moini, Dr
Moïni, Dr, Principal Investigator

Hôpital Haut Lévèque, Bordeaux, France; Recruiting
Clementy, Prof
Clementy, Prof, Principal Investigator

Clinique Amboise Paré, Neuilly, France; Recruiting
Thomas, Dr
Thomas, Dr, Principal Investigator

CHU Charles Nicolle, Rouen, France; Recruiting
Anselme, Dr
Anselme, Dr, Principal Investigator

CH St Philibert, Lomme, France; Recruiting
Graux, Dr
Graux, Dr, Principal Investigator

Hôpital de la Miletrie, Poitiers, France; Recruiting
Legal, Dr
Legal, Dr, Principal Investigator

Hôpital Arnaud de Villeneu, Montpellier, France; Recruiting
Davy, Prof
Davy, Prof, Principal Investigator

CH Albi, Albi, France; Recruiting
Galley, Dr
Galley, dr, Principal Investigator

Clinique Bizet, Paris, France; Recruiting
Ritter, Dr
Ritter, Dr, Principal Investigator

Hôpital de la Cavalle Blanche, Brest, France; Recruiting
Blanc, Dr
Blanc, Dr, Principal Investigator

Hôpital Purpan, Toulouse, France; Recruiting
Delay, Dr
Delay, Dr, Principal Investigator

Clinique de Parly II, Le Chesnay, France; Recruiting
Leclerq, Dr
leclerq, Dr, Principal Investigator

Universität des Saarlandes, Homburg, Germany; Recruiting
G Fröhlig, MD
Fröhlig, Dr, Principal Investigator

Kerckhoff-Klinik GmbH, Bad Nauheim, Germany; Recruiting
Sperzel, MD
Sperzel, Dr, Principal Investigator

Herzkreislaufklinik, Bad Bevensen, Germany; Recruiting
Mletzko, Dr
Mletzko, Dr, Principal Investigator

Universitätsklinikum Schleswig-Holstein, Lübeck, Germany; Recruiting
Wiegand, Prof
Wiegand, Prof, Principal Investigator

Krankenhaus Reinbek, Reinbek, Germany; Recruiting
Nägele, Dr
Nägele, Dr, Principal Investigator

Uniklinik Munster, Munster, Germany; Recruiting
Gradaus, Dr
Gradaus, Dr, Principal Investigator

Casa di cura villa pini d'abruzo, Chieti, Italy; Recruiting
Luise, Dr
Luise, Dr, Principal Investigator

Hospital Fernando Fonseca, Amadora, Portugal; Recruiting
Madeira, Dr
Madeira, Dr, Principal Investigator

Northern General Hospital, Sheffield, United Kingdom; Recruiting
Bowes, Dr
Bowes, Dr, Principal Investigator

St Barts Hospital, London, United Kingdom; Recruiting
Schilling, Dr
Schilling, Dr, Principal Investigator

Southampton General Hospital, Southampton, United Kingdom; Recruiting
Morgan, Dr
Morgan, Dr, Principal Investigator

Royal Bournemouth Hospital, Bournemouth, United Kingdom; Recruiting
Sopher, Dr
Sopher, Dr, Principal Investigator

Starting date: May 2006
Ending date: December 2008
Last updated: August 6, 2008