Biventricular Tachycardias Outcome Trial (BITAC)

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.

Study Overview

• Status: Completed
• Conditions: Biventricular Tachycardias
• Intervention / Treatment: Device: Ovatio CRT 6750; Device: Ovatio CRT 6750

• Study Type: Interventional
• Enrollment (Actual): 481
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Antwepen, Belgium, 2060
    • Algemeen Ziekenhuis
• Canada
  • Edmonton, Canada, T5A 0A1
    • Grey-Nuns Hospital
  • Edmonton, Canada, T5A 0A1
    • Royal Alexandra Hospital
  • Québec, Canada, G1R 4E4
    • Laval UH, Ste Foy
• France
  • Albi, France
    • CH Albi
  • Angers, France, 49000
    • CH Angers
  • Antony, France
    • Hopital Prive d'Antony
  • Bordeaux, France
    • Hopital Haut Leveque
  • Brest, France
    • Hôpital de la Cavalle Blanche
  • Le Chesnay, France
    • Clinique de Parly II
  • Lomme, France
    • CH St Philibert
  • Marseille, France, 13000
    • CHU Hopital Nord
  • Marseille, France, 13000
    • CHU Hopital La Timone
  • Marseille, France, 13000
    • CHU Hôpital Nord - Marseille
  • Marseille, France, 13000
    • Clinique Beauregard
  • Marseille, France, 13000
    • Clinique Clairval
  • Montpellier, France
    • Hôpital Arnaud de Villeneu
  • Neuilly, France
    • Clinique Amboise Paré
  • Nice, France, 6000
    • CHU Hopital Pasteur
  • Nimes, France, 30000
    • CHU Groupe Carémeau
  • Orléans, France, 45000
    • C.H.R Hopital De La Source
  • Paris, France
    • Clinique Bizet
  • Pau, France, 64000
    • CH Pau
  • Poitiers, France
    • Hôpital de la Milétrie
  • Rouen, France
    • CHU Charles Nicolle
  • Saint Etienne, France, 42000
    • CHU Hopital Nord
  • St Denis, France, 93200
    • Centre Cardiologique du Nord
  • Toulon, France, 83000
    • Hopital Font Pré
  • Toulouse, France
    • Hopital Purpan
• Germany
  • Bad Bevensen, Germany
    • Herzkreislaufklinik
  • Bad Nauheim, Germany
    • Kerckhoff-Klinik GmbH
  • Berlin, Germany, 10871
    • Praxis Westend
  • Heidelberg, Germany, 69118
    • Universitatsklinik Med. Klinik Heidelberg
  • Homburg, Germany
    • Universität Des Saarlandes
  • Lübeck, Germany
    • Universitätsklinikum Schleswig-Holstein
  • Munster, Germany
    • Uniklinik Münster
  • Reinbek, Germany
    • Krankenhaus Reinbek
• Italy
  • Asti, Italy, 14100
    • Ospedale Civile di Asti
  • Chieti, Italy
    • Casa di cura villa pini d'abruzo
  • Valencia, Italy, 46006
    • Hospital Clínico
• Portugal
  • Amadora, Portugal
    • Hospital Fernando Fonseca
• Spain
  • Vigo, Spain, 36200
    • CHUVI
• Sweden
  • Danderyd, Sweden, 18211
    • Danderyds Sjukhus AB
  • Orebro, Sweden, 70015
    • Orebro universitetssjukhus
• United Kingdom
  • Bournemouth, United Kingdom
    • Royal Bournemouth Hospital
  • Leicester, United Kingdom, LE19
    • Glenfield Hospital
  • London, United Kingdom
    • St Barts Hospital
  • Sheffield, United Kingdom
    • Northern General Hospital
  • Southampton, United Kingdom
    • Southampton General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Slow VT zone programmed as a "Monitoring" zone (Monitoring arm)	Device: Ovatio CRT 6750; Slow VT zone programmed as a "Monitoring" zone (Monitoring arm); Device: Ovatio CRT 6750; Slow VT zone programmed with ATP therapies (therapy arm).
Experimental: 2; Slow VT zone programmed with ATP therapies (therapy arm).	Device: Ovatio CRT 6750; Slow VT zone programmed as a "Monitoring" zone (Monitoring arm); Device: Ovatio CRT 6750; Slow VT zone programmed with ATP therapies (therapy arm).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: LivaNova
• Investigators: Principal Investigator: Alexander Bauer, Universitätsklinikum Heidelberg, 69120 Heidelberg

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: August 4, 2008
• First Submitted That Met QC Criteria: August 6, 2008
• First Posted (Estimate): August 7, 2008

Study Record Updates

• Last Update Posted (Estimate): December 22, 2011
• Last Update Submitted That Met QC Criteria: December 21, 2011
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: treatment; follow-up; Incidence; Clinical; during; Slow VT, CRT-D, ATP therapy; of slow VTs; in CRT-D patients; relevance; VTs; 2-years
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia
• Other Study ID Numbers: BITAC - ITAC04