Clinical trial NCT00729235: Biventricular Tachycardias Outcome Trial
Official title: Biventricular Tachycardias Outcome Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Biventricular Tachycardias
Keywords: Slow VT, CRT-D, ATP therapy
Incidence
of slow VTs
in CRT-D patients
Clinical
relevance
treatment
VTs
during
2-years
follow-up
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2008-08-07
Enrollment: 481
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Incidence of slow ventricular tachycardias (Slow VTs) in CRT-ICD pts;
timeFrame: 24 months
measure: ATP therapy efficacy on slow VTs conversion.
timeFrame: 24 months
Secondary outcomes:
measure: Efficacy of ATP therapies on Slow VTs according to therapy setting (delivery in LV only, in RV only, or in LV+RV)
timeFrame: 24 months
measure: Tvar risk stratification
timeFrame: 24 months
measure: "unscheduled visits" or "hospital re-admissions" due to slow VTs;
timeFrame: 24 months
measure: Incidence of adverse events (AEs) in the studied population
timeFrame: 24 months
Other outcomes:
Locations:
city: Antwepen
country: Belgium
facility: Algemeen Ziekenhuis
city: Edmonton
country: Canada
facility: Grey-Nuns Hospital
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
city: Québec
country: Canada
facility: Laval UH, Ste Foy
city: Albi
country: France
facility: CH Albi
city: Angers
country: France
facility: CH Angers
city: Antony
country: France
facility: Hôpital privé d'Antony
city: Bordeaux
country: France
facility: Hôpital Haut Lévèque
city: Brest
country: France
facility: Hôpital de la Cavalle Blanche
city: Le Chesnay
country: France
facility: Clinique de Parly II
city: Lomme
country: France
facility: CH St Philibert
city: Marseille
country: France
facility: CHU Hopital La Timone
city: Marseille
country: France
facility: CHU Hôpital Nord - Marseille
city: Marseille
country: France
facility: CHU Hôpital Nord
city: Marseille
country: France
facility: Clinique Beauregard
city: Marseille
country: France
facility: Clinique Clairval
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneu
city: Neuilly
country: France
facility: Clinique Amboise Paré
city: Nice
country: France
facility: CHU Hopital Pasteur
city: Nimes
country: France
facility: CHU Groupe Carémeau
city: Orléans
country: France
facility: C.H.R Hopital De La Source
city: Paris
country: France
facility: Clinique Bizet
city: Pau
country: France
facility: CH Pau
city: Poitiers
country: France
facility: Hôpital de la Miletrie
city: Rouen
country: France
facility: CHU Charles Nicolle
city: Saint Etienne
country: France
facility: CHU Hôpital Nord
city: St Denis
country: France
facility: Centre Cardiologique Du Nord
city: Toulon
country: France
facility: Hopital Font Pré
city: Toulouse
country: France
facility: Hôpital Purpan
city: Bad Bevensen
country: Germany
facility: Herzkreislaufklinik
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH
city: Berlin
country: Germany
facility: Praxis Westend
city: Heidelberg
country: Germany
facility: Universitatsklinik Med. Klinik Heidelberg
city: Homburg
country: Germany
facility: Universität des Saarlandes
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Munster
country: Germany
facility: Uniklinik Munster
city: Reinbek
country: Germany
facility: Krankenhaus Reinbek
city: Asti
country: Italy
facility: Ospedale Civile Di Asti
city: Chieti
country: Italy
facility: Casa di cura villa pini d'abruzo
city: Valencia
country: Italy
facility: Hospital Clinico
city: Amadora
country: Portugal
facility: Hospital Fernando Fonseca
city: Vigo
country: Spain
facility: CHUVI
city: Danderyd
country: Sweden
facility: Danderyds Sjukhus Ab
city: Orebro
country: Sweden
facility: Orebro Universitetssjukhus
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
city: London
country: United Kingdom
facility: St Barts Hospital
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Universitätsklinikum Heidelberg, 69120 Heidelberg
name: Alexander Bauer
role: PRINCIPAL_INVESTIGATOR
References: