Biventricular Tachycardias Outcome Trial - Full Text View

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

Genetics Home Reference related topics:

Brugada syndrome short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Biventricular Tachycardias Outcome Trial

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 ]

Estimated Enrollment:	404
Study Start Date:	May 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Slow VT zone programmed as a "Monitoring" zone (Monitoring arm)	Device: Ovatio CRT 6750 Slow VT zone programmed as a "Monitoring" zone (Monitoring arm)
2: Experimental 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

Contacts


Contact: Alberto Borri	39 0161 487 211	Alberto.borri@sorin.com

Locations


France
	Hôpital privé d'Antony	Recruiting
	Antony, France
	Contact: Moini, Dr
	Principal Investigator: Moïni, Dr
	Hôpital Haut Lévèque	Recruiting
	Bordeaux, France
	Contact: Clementy, Prof
	Principal Investigator: Clementy, Prof
	Clinique Amboise Paré	Recruiting
	Neuilly, France
	Contact: Thomas, Dr
	Principal Investigator: Thomas, Dr
	CHU Charles Nicolle	Recruiting
	Rouen, France
	Contact: Anselme, Dr
	Principal Investigator: Anselme, Dr
	CH St Philibert	Recruiting
	Lomme, France
	Contact: Graux, Dr
	Principal Investigator: Graux, Dr
	Hôpital de la Miletrie	Recruiting
	Poitiers, France
	Contact: Legal, Dr
	Principal Investigator: Legal, Dr
	Clinique de Parly II	Recruiting
	Le Chesnay, France
	Contact: Leclerq, Dr
	Principal Investigator: leclerq, Dr
	CH Albi	Recruiting
	Albi, France
	Contact: Galley, Dr
	Principal Investigator: Galley, dr
	Clinique Bizet	Recruiting
	Paris, France
	Contact: Ritter, Dr
	Principal Investigator: Ritter, Dr
	Hôpital de la Cavalle Blanche	Recruiting
	Brest, France
	Contact: Blanc, Dr
	Principal Investigator: Blanc, Dr
	Hôpital Purpan	Recruiting
	Toulouse, France
	Contact: Delay, Dr
	Principal Investigator: Delay, Dr
	Hôpital Arnaud de Villeneu	Recruiting
	Montpellier, France
	Contact: Davy, Prof
	Principal Investigator: Davy, Prof

Germany
	Universität des Saarlandes	Recruiting
	Homburg, Germany
	Contact: G Fröhlig, MD
	Principal Investigator: Fröhlig, Dr
	Kerckhoff-Klinik GmbH	Recruiting
	Bad Nauheim, Germany
	Contact: Sperzel, MD
	Principal Investigator: Sperzel, Dr
	Herzkreislaufklinik	Recruiting
	Bad Bevensen, Germany
	Contact: Mletzko, Dr
	Principal Investigator: Mletzko, Dr
	Universitätsklinikum Schleswig-Holstein	Recruiting
	Lübeck, Germany
	Contact: Wiegand, Prof
	Principal Investigator: Wiegand, Prof
	Krankenhaus Reinbek	Recruiting
	Reinbek, Germany
	Contact: Nägele, Dr
	Principal Investigator: Nägele, Dr
	Uniklinik Munster	Recruiting
	Munster, Germany
	Contact: Gradaus, Dr
	Principal Investigator: Gradaus, Dr

Italy
	Casa di cura villa pini d'abruzo	Recruiting
	Chieti, Italy
	Contact: Luise, Dr
	Principal Investigator: Luise, Dr

Portugal
	Hospital Fernando Fonseca	Recruiting
	Amadora, Portugal
	Contact: Madeira, Dr
	Principal Investigator: Madeira, Dr

United Kingdom
	Northern General Hospital	Recruiting
	Sheffield, United Kingdom
	Contact: Bowes, Dr
	Principal Investigator: Bowes, Dr
	St Barts Hospital	Recruiting
	London, United Kingdom
	Contact: Schilling, Dr
	Principal Investigator: Schilling, Dr
	Southampton General Hospital	Recruiting
	Southampton, United Kingdom
	Contact: Morgan, Dr
	Principal Investigator: Morgan, Dr
	Royal Bournemouth Hospital	Recruiting
	Bournemouth, United Kingdom
	Contact: Sopher, Dr
	Principal Investigator: Sopher, Dr

Sponsors and Collaborators

Sorin Group

Investigators


Principal Investigator:	Alexander Bauer	Universitätsklinikum Heidelberg, 69120 Heidelberg

More Information

Responsible Party:	Universitätsklinikum Heidelberg ( Alexander Bauer / Principal investigator )
Study ID Numbers:	BITAC - ITAC04
First Received:	August 4, 2008
Last Updated:	August 6, 2008
ClinicalTrials.gov Identifier:	NCT00729235
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

Study placed in the following topic categories:

Heart Diseases

Tachycardia

Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Sorin Group
Information provided by:	Sorin Group
ClinicalTrials.gov Identifier:	NCT00729235