Status:
COMPLETED
Biventricular Tachycardias Outcome Trial
Lead Sponsor:
LivaNova
Conditions:
Biventricular Tachycardias
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 tha...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
481 Patients enrolled
Trial Details
Trial ID
NCT00729235
Start Date
May 1 2006
End Date
November 1 2011
Last Update
December 22 2011
Active Locations (49)
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1
Algemeen Ziekenhuis
Antwepen, Belgium, 2060
2
Grey-Nuns Hospital
Edmonton, Canada, T5A 0A1
3
Royal Alexandra Hospital
Edmonton, Canada, T5A 0A1
4
Laval UH, Ste Foy
Québec, Canada, G1R 4E4