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Biventricular Tachycardias Outcome Trial (BITAC)
This study is currently recruiting participants.
Study NCT00729235   Information provided by Sorin Group
First Received: August 4, 2008   Last Updated: August 6, 2008   History of Changes

August 4, 2008
August 6, 2008
May 2006
December 2008   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00729235 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Biventricular Tachycardias Outcome Trial
Biventricular Tachycardias Outcome Trial

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.

 
Phase IV
Interventional
Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Biventricular Tachycardias
Device: Ovatio CRT 6750
  • Experimental: Slow VT zone programmed as a "Monitoring" zone (Monitoring arm)
  • Experimental: Slow VT zone programmed with ATP therapies (therapy arm).
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
404
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Alberto Borri 39 0161 487 211 Alberto.borri@sorin.com
France,   Germany,   Italy,   Portugal,   United Kingdom
 
NCT00729235
Alexander Bauer / Principal investigator, Universitätsklinikum Heidelberg
BITAC - ITAC04
Sorin Group
 
Principal Investigator: Alexander Bauer Universitätsklinikum Heidelberg, 69120 Heidelberg
Sorin Group
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP