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Biventricular Tachycardias Outcome Trial (BITAC)

This study is currently recruiting participants.
Verified by Sorin Group, August 2008

Sponsored by: Sorin Group
Information provided by: Sorin Group
ClinicalTrials.gov Identifier: NCT00729235
  Purpose

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.


Condition Intervention Phase
Biventricular Tachycardias
Device: Ovatio CRT 6750
Phase IV

Genetics Home Reference related topics:   Brugada syndrome    short QT syndrome   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Biventricular Tachycardias Outcome Trial

Further study details as provided by Sorin Group:

Primary Outcome Measures:
  • Incidence of slow ventricular tachycardias (Slow VTs) in CRT-ICD pts; [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • ATP therapy efficacy on slow VTs conversion. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy of ATP therapies on Slow VTs according to therapy setting (delivery in LV only, in RV only, or in LV+RV) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Tvar risk stratification [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • "unscheduled visits" or "hospital re-admissions" due to slow VTs; [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Incidence of adverse events (AEs) in the studied population [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   404
Study Start Date:   May 2006
Estimated Study Completion Date:   December 2008
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Slow VT zone programmed as a "Monitoring" zone (Monitoring arm)
Device: Ovatio CRT 6750
Slow VT zone programmed as a "Monitoring" zone (Monitoring arm)
2: Experimental
Slow VT zone programmed with ATP therapies (therapy arm).
Device: Ovatio CRT 6750
Slow VT zone programmed with ATP therapies (therapy arm).

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729235

Contacts
Contact: Alberto Borri     39 0161 487 211     Alberto.borri@sorin.com    

Locations
France
Hôpital privé d'Antony     Recruiting
      Antony, France
      Contact: Moini, Dr            
      Principal Investigator: Moïni, Dr            
Hôpital Haut Lévèque     Recruiting
      Bordeaux, France
      Contact: Clementy, Prof            
      Principal Investigator: Clementy, Prof            
Clinique Amboise Paré     Recruiting
      Neuilly, France
      Contact: Thomas, Dr            
      Principal Investigator: Thomas, Dr            
CHU Charles Nicolle     Recruiting
      Rouen, France
      Contact: Anselme, Dr            
      Principal Investigator: Anselme, Dr            
CH St Philibert     Recruiting
      Lomme, France
      Contact: Graux, Dr            
      Principal Investigator: Graux, Dr            
Hôpital de la Miletrie     Recruiting
      Poitiers, France
      Contact: Legal, Dr            
      Principal Investigator: Legal, Dr            
Clinique de Parly II     Recruiting
      Le Chesnay, France
      Contact: Leclerq, Dr            
      Principal Investigator: leclerq, Dr            
CH Albi     Recruiting
      Albi, France
      Contact: Galley, Dr            
      Principal Investigator: Galley, dr            
Clinique Bizet     Recruiting
      Paris, France
      Contact: Ritter, Dr            
      Principal Investigator: Ritter, Dr            
Hôpital de la Cavalle Blanche     Recruiting
      Brest, France
      Contact: Blanc, Dr            
      Principal Investigator: Blanc, Dr            
Hôpital Purpan     Recruiting
      Toulouse, France
      Contact: Delay, Dr            
      Principal Investigator: Delay, Dr            
Hôpital Arnaud de Villeneu     Recruiting
      Montpellier, France
      Contact: Davy, Prof            
      Principal Investigator: Davy, Prof            
Germany
Universität des Saarlandes     Recruiting
      Homburg, Germany
      Contact: G Fröhlig, MD            
      Principal Investigator: Fröhlig, Dr            
Kerckhoff-Klinik GmbH     Recruiting
      Bad Nauheim, Germany
      Contact: Sperzel, MD            
      Principal Investigator: Sperzel, Dr            
Herzkreislaufklinik     Recruiting
      Bad Bevensen, Germany
      Contact: Mletzko, Dr            
      Principal Investigator: Mletzko, Dr            
Universitätsklinikum Schleswig-Holstein     Recruiting
      Lübeck, Germany
      Contact: Wiegand, Prof            
      Principal Investigator: Wiegand, Prof            
Krankenhaus Reinbek     Recruiting
      Reinbek, Germany
      Contact: Nägele, Dr            
      Principal Investigator: Nägele, Dr            
Uniklinik Munster     Recruiting
      Munster, Germany
      Contact: Gradaus, Dr            
      Principal Investigator: Gradaus, Dr            
Italy
Casa di cura villa pini d'abruzo     Recruiting
      Chieti, Italy
      Contact: Luise, Dr            
      Principal Investigator: Luise, Dr            
Portugal
Hospital Fernando Fonseca     Recruiting
      Amadora, Portugal
      Contact: Madeira, Dr            
      Principal Investigator: Madeira, Dr            
United Kingdom
Northern General Hospital     Recruiting
      Sheffield, United Kingdom
      Contact: Bowes, Dr            
      Principal Investigator: Bowes, Dr            
St Barts Hospital     Recruiting
      London, United Kingdom
      Contact: Schilling, Dr            
      Principal Investigator: Schilling, Dr            
Southampton General Hospital     Recruiting
      Southampton, United Kingdom
      Contact: Morgan, Dr            
      Principal Investigator: Morgan, Dr            
Royal Bournemouth Hospital     Recruiting
      Bournemouth, United Kingdom
      Contact: Sopher, Dr            
      Principal Investigator: Sopher, Dr            

Sponsors and Collaborators
Sorin Group

Investigators
Principal Investigator:     Alexander Bauer     Universitätsklinikum Heidelberg, 69120 Heidelberg    
  More Information


Responsible Party:   Universitätsklinikum Heidelberg ( Alexander Bauer / Principal investigator )
Study ID Numbers:   BITAC - ITAC04
First Received:   August 4, 2008
Last Updated:   August 6, 2008
ClinicalTrials.gov Identifier:   NCT00729235
Health Authority:   Germany: Federal Institute for Drugs and Medical Devices;   France: Afssaps - French Health Products Safety Agency;   Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Sorin Group:
Slow VT, CRT-D, ATP therapy  
Incidence  
of slow VTs  
in CRT-D patients  
Clinical  
relevance  
treatment
VTs
during
2-years
follow-up

Study placed in the following topic categories:
Heart Diseases
Tachycardia
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 20, 2008




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