Completed

NCT Number: NCT00729235

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.

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Key information

Conditions

Biventricular Tachycardias

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Algemeen Ziekenhuis, Antwepen, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ovatio CRT 6750

Device

Slow VT zone programmed as a "Monitoring" zone (Monitoring arm)

Primary outcomes

Incidence of slow ventricular tachycardias (Slow VTs) in CRT-ICD pts;

Time frame: 24 months
ATP therapy efficacy on slow VTs conversion.

Time frame: 24 months

Secondary outcomes

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
Tvar risk stratification

Time frame: 24 months
"unscheduled visits" or "hospital re-admissions" due to slow VTs;

Time frame: 24 months
Incidence of adverse events (AEs) in the studied population

Time frame: 24 months

Sponsors and collaborators

Lead sponsor

LivaNova

Industry

Registry information

Acronym: BITAC

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2011
First posted: Aug 7, 2008
Registry last updated: Dec 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.