Biventricular TachycardiasPhase 4BITACNCT00729235
Biventricular Tachycardias Outcome Trial
A Phase 4 study testing Ovatio CRT 6750 in people with Biventricular Tachycardias, run by LivaNova at 49 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biventricular Tachycardias
- What is being tested?
- Ovatio CRT 6750
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 481 participants
- Where
- 49 sitesin 9 countries
- Study dates
- May 2006to Nov 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
49 sites in 9 countries.
49 sites in 9 countries
France25 sites
CH Albi
Albi
CH Angers
Angers, 49000
Hôpital privé d'Antony
Antony
Hôpital Haut Lévèque
Bordeaux
Hôpital de la Cavalle Blanche
Brest
Clinique de Parly II
Le Chesnay
CH St Philibert
Lomme
CHU Hopital La Timone
Marseille, 13000
CHU Hôpital Nord - Marseille
Marseille, 13000
CHU Hôpital Nord
Marseille, 13000
Clinique Beauregard
Marseille, 13000
Clinique Clairval
Marseille, 13000
Hôpital Arnaud de Villeneu
Montpellier
Clinique Amboise Paré
Neuilly
CHU Hopital Pasteur
Nice, 6000
CHU Groupe Carémeau
Nîmes, 30000
C.H.R Hopital De La Source
Orléans, 45000
Clinique Bizet
Paris
CH Pau
Pau, 64000
Hôpital de la Miletrie
Poitiers
CHU Charles Nicolle
Rouen
Centre Cardiologique Du Nord
Saint-Denis, 93200
CHU Hôpital Nord
Saint-Etienne, 42000
Hopital Font Pré
Toulon, 83000
Hôpital Purpan
Toulouse
Germany8 sites
Herzkreislaufklinik
Bad Bevensen
Kerckhoff-Klinik GmbH
Bad Nauheim
Praxis Westend
Berlin, 10871
Universitatsklinik Med. Klinik Heidelberg
Heidelberg, 69118
Universität des Saarlandes
Homburg
Universitätsklinikum Schleswig-Holstein
Lübeck
Uniklinik Munster
Münster
Krankenhaus Reinbek
Reinbek
United Kingdom5 sites
Royal Bournemouth Hospital
Bournemouth
Glenfield Hospital
Leicester, LE19
St Barts Hospital
London
Northern General Hospital
Sheffield
Southampton General Hospital
Southampton
Canada3 sites
Grey-Nuns Hospital
Edmonton, T5A 0A1
Royal Alexandra Hospital
Edmonton, T5A 0A1
Laval UH, Ste Foy
Québec, G1R 4E4
Italy3 sites
Ospedale Civile Di Asti
Asti, 14100
Casa di cura villa pini d'abruzo
Chieti
Hospital Clinico
Valencia, 46006
Sweden2 sites
Danderyds Sjukhus Ab
Danderyd, 18211
Orebro Universitetssjukhus
Örebro, 70015
About this study
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.
Read more
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.
- Conditions
- Biventricular Tachycardias
- Being tested
- Ovatio CRT 6750
- Keywords
- Slow VT, CRT-D, ATP therapy, Incidence, of slow VTs, in CRT-D patients, Clinical, relevance, treatment, VTs, during, 2-years, follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovatio CRT 6750Device
Slow VT zone programmed as a "Monitoring" zone (Monitoring arm)
Ovatio CRT 6750Device
Slow VT zone programmed with ATP therapies (therapy arm).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Slow VT zone programmed as a "Monitoring" zone (Monitoring arm) Receives: Device: Ovatio CRT 6750 |
| 2 | Experimental | Slow VT zone programmed with ATP therapies (therapy arm). Receives: Device: Ovatio CRT 6750 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of slow ventricular tachycardias (Slow VTs) in CRT-ICD pts;
Measured: 24 months
ATP therapy efficacy on slow VTs conversion.
Measured: 24 months
Secondary outcomes (4)
Efficacy of ATP therapies on Slow VTs according to therapy setting (delivery in LV only, in RV only, or in LV+RV)
Measured: 24 months
Tvar risk stratification
Measured: 24 months
"unscheduled visits" or "hospital re-admissions" due to slow VTs;
Measured: 24 months
Incidence of adverse events (AEs) in the studied population
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2008 (estimated)
- Study startMay 2006
- Primary completionDec 2008
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biventricular TachycardiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 481 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alexander Bauer, Principal investigator, Universitätsklinikum Heidelberg, 69120 Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729235
- Sponsor's protocol ID
- BITAC - ITAC04
- Acronym
- BITAC
- Status last verified
- Jun 2010
- First submitted
- 4 Aug 2008
- Last updated
- 22 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biventricular Tachycardias Outcome Trial
- ClinicalTrials.gov ID
- NCT00729235
- Acronym / sponsor ID
- BITAC / BITAC - ITAC04
- Conditions
- Biventricular Tachycardias
- Keywords
- Slow VT, CRT-D, ATP therapy, Incidence, of slow VTs, in CRT-D patients, Clinical, relevance, treatment, VTs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 481 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 7 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Ovatio CRT 6750Slow VT zone programmed as a "Monitoring" zone (Monitoring arm) |
| 2 | Experimental | Device: Ovatio CRT 6750Slow VT zone programmed with ATP therapies (therapy arm). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ovatio CRT 6750Slow VT zone programmed as a "Monitoring" zone (Monitoring arm) | Device | 1 |
| Ovatio CRT 6750Slow VT zone programmed with ATP therapies (therapy arm). | Device | 2 |
Primary outcome
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
4 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Bauer principal investigator
Universitätsklinikum Heidelberg, 69120 Heidelberg
49 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ovatio CRT 6750 in people with Biventricular Tachycardias, run by LivaNova at 49 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in France, Germany, United Kingdom, Canada, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of slow ventricular tachycardias (Slow VTs) in CRT-ICD pts; (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2011.