Biventricular Tachycardias Outcome Trial (BITAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00729235
Recruitment Status : Completed
First Posted : August 7, 2008
Last Update Posted : December 22, 2011
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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.

Condition or disease Intervention/treatment Phase
Biventricular Tachycardias Device: Ovatio CRT 6750 Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 481 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Biventricular Tachycardias Outcome Trial
Study Start Date : May 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : November 2011

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)
Experimental: 2
Slow VT zone programmed with ATP therapies (therapy arm).
Device: Ovatio CRT 6750
Slow VT zone programmed with ATP therapies (therapy arm).

Primary Outcome Measures :
  1. Incidence of slow ventricular tachycardias (Slow VTs) in CRT-ICD pts; [ Time Frame: 24 months ]
  2. ATP therapy efficacy on slow VTs conversion. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. Tvar risk stratification [ Time Frame: 24 months ]
  3. "unscheduled visits" or "hospital re-admissions" due to slow VTs; [ Time Frame: 24 months ]
  4. Incidence of adverse events (AEs) in the studied population [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00729235

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Sponsors and Collaborators
Principal Investigator: Alexander Bauer Universitätsklinikum Heidelberg, 69120 Heidelberg

Responsible Party: Alexander Bauer / Principal investigator, Universitätsklinikum Heidelberg Identifier: NCT00729235     History of Changes
Other Study ID Numbers: BITAC - ITAC04
First Posted: August 7, 2008    Key Record Dates
Last Update Posted: December 22, 2011
Last Verified: June 2010

Keywords provided by LivaNova:
Slow VT, CRT-D, ATP therapy
of slow VTs
in CRT-D patients

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes