Biventricular Tachycardias Outcome Trial - Full Text View

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Biventricular Tachycardias Outcome Trial

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

U.S. FDA Resources

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 ]

Enrollment:	481
Study Start Date:	May 2006
Study Completion Date:	November 2011
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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).

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

Show 49 Study Locations

Sponsors and Collaborators

Sorin Group

Investigators

Principal Investigator:

Alexander Bauer

Universitätsklinikum Heidelberg, 69120 Heidelberg

More Information

No publications provided

Responsible Party:	Alexander Bauer / Principal investigator, Universitätsklinikum Heidelberg
ClinicalTrials.gov Identifier:	NCT00729235 History of Changes
Other Study ID Numbers:	BITAC - ITAC04
Study First Received:	August 4, 2008
Last Updated:	December 21, 2011
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

Additional relevant MeSH terms:

Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 13, 2012