TachycardiaPhase 4OPTIONNCT00729703
Optimal Anti-tachycardia Therapy in Implantable Cardioverter-defibrillator (ICD) Patients Without Pacing Indications
A Phase 4 study testing Ovatio DR 6550 in people with Tachycardia, run by LivaNova at 55 sites in 9 countries.
Trial summary
This study evaluates the impact of a new pacing mode avoiding unnecessary ventricular stimulation in combination with advanced dual chamber detection with slow VT management on the clinical outcome for hospitalization and mortality and inadequate therapy in medically stable, ICD-indicated patients with impaired left… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia
- What is being tested?
- Ovatio DR 6550
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 462 participants
- Where
- 55 sitesin 9 countries
- Study dates
- Jun 2006to Oct 2013
- 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 for an ICD system accordingly to the relevant currently-approved ACC/AHA guidelines 1 or ESC guidelines 35 or any relevant currently-approved local guidelines for the implantation of an ICD-system
- Impaired left ventricular function demonstrated by a left-ventricular ejection fraction (LVEF) ≤ 40 %, measured by angio-scintigraphy, echocardiography, or contrast ventriculogram.
- An optimal (as determined by the enrolling physician) medical regimen.
- Patient has received all relevant information on the study, and has signed and dated a consent form.
Who cannot join
- Any generally accepted indication for standard cardiac pacing, or any contraindication for standard cardiac pacing.
- Any indication for CRT accordingly to the relevant currently-approved ACC/AHA1 or ESC35 guidelines for the implantation of a CRT system.
- Any contraindication for ICD therapy and the implant of a dual chamber ICD.
- ICD replacement
- Chronic atrial arrhythmias or cardioversion for atrial fibrillation within the past month.
- A PR interval > 250 ms or AR interval > 300 ms measured at implant.
Show all 18Show fewer
- Hypertrophic obstructive cardiomyopathy.
- Acute myocarditis.
- Unstable coronary symptoms or myocardial infarction within the last month.
- Recent (within the last month) or planned cardiac revascularization or coronary angioplasty.
- Recently performed (in the last month) or planned cardiac surgery
- Already included in another clinical study.
- Life expectancy less than 24 months.
- Inability to understand the purpose of the study or refusal to cooperate.
- Inability or refusal to provide informed consent and, if not part of the informed consent, a Health Insurance Portability and Accountability Act (HIPAA) authorization.
- Unavailability for scheduled follow-up at the implanting or cooperating center.
- Age of less than 18 years.
- Pregnancy
Trial locations and contacts
55 sites in 9 countries.
55 sites in 9 countries
Germany18 sites
Herzkreislaufklinik
Bad Bevensen
Kerckhoff Klinik
Bad Nauheim, 61231
Charite Campus Virchow
Berlin, 13353
Universitätskliniken Bonn
Bonn
Klinikum Coburg
Coburg, 96465
Klinikum Garmisch-Partenkirchen
Garmisch-Partenkirchen, 82467
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 2100
Universität des Saarlandes
Homburg
Universitatsklinikum Schleswig-Holstein Campus Lübeck
Lübeck, 23501
Kardiologische Gemeinschaftspraxis
München, 80337
Universitatsklinikum Grosshadern
München, 81000
DHZ Munchen
München
Klinikum Bogenhausen
München
Klinikum rechts der Isar
München
Uniklinik Munster
Münster
Klinikum der Universität Regensburg
Regensburg, 93047
Krankenhaus der Barmherzigen Brüder
Regensburg, 93047
Universitätsklinik Ulm
Ulm
France16 sites
Centre Hospitalier General
Aix-en-Provence
CHU Le Haut L'Evêque
Bordeaux, 33000
CHU Hôpital Michallon Grenoble
Grenoble
Clinique De Parly II
Le Chesnay, 78150
Clinique les sources
Le Mans
CH ST Philibert
Lomme
Hôpital St Joseph
Lyon, 69000
Hopital Arnaud De Villeneuve
Montpellier, 34294
CHU Nantes
Nantes, 44000
Clinique Bizet
Paris, 75016
CH Pau
Pau, 64000
CHU Charles Nicolle
Rouen, 76000
Clinique Pasteur
Toulouse, 31000
Hôpital Rangueil
Toulouse, 31000
CHU Purpan Toulouse
Toulouse
CHU Tours
Tours
United States5 sites
Piedmont Hospital Research Institute
Atlanta, Georgia, 30303
Atlanta Va Medical Center
Decatur, Georgia, 30301
Pee Dee Cardiology
Florence, South Carolina, 29501
River City Cardiology
Jeffersonville, Ohio, 43128
Southern Medical Research, Llc
Mandeville, Louisiana, 70471
Italy5 sites
Ospedale Civile
Desio, 20033
Ospedale Sacro Cuore Don Calabria
Negrar
Casa Di Cura Citta Di Pavia
Pavia, 27100
Policlinico San Donato
San Donato
Ospedale Clinicizzato San Donato
San Donato Milanese, 20097
Belgium3 sites
Algemeen Ziekenhuis - Antwepen
Antwepen, 2600
Kliniek Maria Middelares - Gent
Ghent, 9050
Heart Center Virga Jesse Ziekenhuis - Hasselt
Hasselt, 3500. 64
United Kingdom3 sites
St Peters Hospital
London
Musgrove Park Hospltal
Taunton, TA1 4DY
Worthing And Southlands Hospital
Worthing, NR20 4LB
Portugal2 sites
Hospital Garcia de Orta
Almada
Hospital Senhora da Oliveira
Guimarães
About this study
Official title: Optimal Antitachycardia Therapy in ICD Patients Without Pacing Indications
This study evaluates the impact of a new pacing mode avoiding unnecessary ventricular stimulation in combination with advanced dual chamber detection with slow VT management on the clinical outcome for hospitalization and mortality and inadequate therapy in medically stable, ICD-indicated patients with impaired left ventricular function (LVEF ≤ 40%) who do not have pacing indications and no indication for Cardiac Resynchronization Therapy (CRT). It compares a new pacing mode avoiding ventricular stimulation when not needed combined with dual chamber detection with a pure ventricular back up pacing and single chamber detection criteria with pure ventricular back up pacing. Therapies are compared in a prospective, randomized, single-blinded, parallel trial with a 24-month randomized treatment period. Randomization follows a 1:1 ratio. ICD therapy is enabled for all patients throughout the study. All patients receive optimal drug therapy for arrhythmia and heart failure treatment.
Read the detailed description
All patients will receive an implantable cardioverter defibrillator OVATIO™ DR model 6550 or a later Sorin Group device offering the same functions. After Enrolment visit but before implant, patients will be randomized in two arms according to the parallel study design. Whenever possible before implant there will be the first Holter recording for the Tvar risk stratification procedure. In case Tvar recording could not be performed before implant it has to be performed before patient leaves the hospital post implant in unpaced rhythm.
The dual-chamber arm will be programmed to 3 detection zones with PARAD+ activated.
The TDI for the slow VT zone will be set to 500 ms (120 bpm - or in case the resting rate is higher than 90 bpm it is recommended to adjust this parameter to: resting rate + 30 bpm) and at least one ATP program activated as specified in table 1.
A VT zone with a TDI of 353 ms (170 bpm) in case of no history of VT or a TDI cycle length equalling slowest documented VT interval (spontaneous or induced) plus 50 ms is required. In this 2nd VT zone therapies need to be activated in this group.
AAIsafeR2 mode will be activated with a basic rate of 60 bpm. The single-chamber arm will be programmed to optimal detection with Acceleration (Onset), Stability and Long Cycle Search (VTLC) activated. A VT zone is requested in this group, with the same programming procedures as described above. Therapies will be set according to the clinical judgment of the participating investigators but a Slow VT-zone with TDI 500 ms in monitoring setting at least is required.
- Conditions
- Tachycardia
- Being tested
- Ovatio DR 6550
- Keywords
- ICD, Minimized, ventricular, pacing, indication, Clinical outcome, Inappropriate shock
- Medical subject headings
- Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovatio DR 6550Device
Dual-chamber ICD therapy with minimized ventricular pacing
OVATIO DR 6550Device
Single-chamber device therapy with settings which are common in clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Dual-chamber detection and activated treatment (at least ATP) in the slow VT-zone plus activated AAIsafeR pacing (basic rate 60 bpm). Receives: Device: Ovatio DR 6550 |
| 2 | Experimental | Single-chamber ICD following clinical practice but with a monitoring zone active to allow the documentation of all occurring ventricular arrhythmias Receives: Device: OVATIO DR 6550 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The first part is the time to first occurrence of inappropriate ICD shock therapy. The second part is the composite endpoint of time to first occurrence of death (all causes)or Hospitalizations due to cardio-vascular event.
Measured: implant, 3 months, 9 months, 15 months, 21 months and 27 months
Secondary outcomes (15)
all cause mortality and cardio-vascular related mortality
Measured: 27 months follow up
Hospitalizations due to cardio-vascular event (specified for each type of event)
Measured: 27 months follow up
Time to first occurrence of inappropriate ICD shock therapy
Measured: 27 months follow up
Evaluation of the impact of the different therapies on quality of life and heart failure status
Measured: 27 months follow up
Sensitivity and specificity for VT/SVT discrimination for the first 100 patients in each group.
Measured: 27 months
Inappropriate overall device reactions defined by inappropriate shock and/or ATP therapy or inappropriate therapy delay/inhibition > 2 minutes on VTs
Measured: 27 months
time to first documented AF occurrence and number of patients moving into permanent or persistent AF
Measured: 27 months follow up
Cardiac dimensions obtained by echo evaluation for a subset of patients of both groups
Measured: Baseline and 27 months
Slow VT incidence
Measured: 27 months
Unscheduled visits and hospitalizations due to slow VT
Measured: 27 months follow up
System related complications including lead dislodgements, exit block, oversensing which requires programming corrections, infections, complications which require reintervention
Measured: 27 months follow up
Cumulative percentage of ventricular pacing and proportion of patients with 0% V pacing.
Measured: 27 months follow up
Overall success rate of ATP in the FVT zone
Measured: 27 months
Cost effectiveness of applied ICD therapy
Measured: 27 months
PPV and NPV for Tvar risk stratification
Measured: 27 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 startJun 2006
- Primary completionDec 2011
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TachycardiaStudies 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
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kolb, Principal investigator, Deutsches Herzzentrum München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729703
- Sponsor's protocol ID
- OPTION - ITAC03
- Acronym
- OPTION
- Status last verified
- Jan 2015
- First submitted
- 4 Aug 2008
- Last updated
- 13 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kolb C, Tzeis S, Sturmer M, Babuty D, Schwab JO, Mantovani G, Janko S, Aime E, Ocklenburg R, Sick P. Rationale and design of the OPTION study: optimal antitachycardia therapy in ICD patients without pacing indications. Pacing Clin Electrophysiol. 2010 Sep;33(9):1141-8. doi: 10.1111/j.1540-8159.2010.02790.x.
PubMed 20487351Kolb C, Sturmer M, Sick P, Reif S, Davy JM, Molon G, Schwab JO, Mantovani G, Dan D, Lennerz C, Borri-Brunetto A, Babuty D. Reduced risk for inappropriate implantable cardioverter-defibrillator shocks with dual-chamber therapy compared with single-chamber therapy: results of the randomized OPTION study. JACC Heart Fail. 2014 Dec;2(6):611-9. doi: 10.1016/j.jchf.2014.05.015. Epub 2014 Oct 1.
PubMed 25282033
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Antitachycardia Therapy in ICD Patients Without Pacing Indications
- ClinicalTrials.gov ID
- NCT00729703
- Acronym / sponsor ID
- OPTION / OPTION - ITAC03
- Conditions
- Tachycardia
- Keywords
- ICD, Minimized, ventricular, pacing, indication, Clinical outcome, Inappropriate shock
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Oct 2013 (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 study evaluates the impact of a new pacing mode avoiding unnecessary ventricular stimulation in combination with advanced dual chamber detection with slow VT management on the clinical outcome for hospitalization and mortality and inadequate therapy in medically stable, ICD-indicated patients with impaired left ventricular function (LVEF ≤ 40%) who do not have pacing indications and no indication for Cardiac Resynchronization Therapy (CRT). It compares a new pacing mode avoiding ventricular stimulation when not needed combined with dual chamber detection with a pure ventricular back up pacing and single chamber detection criteria with pure ventricular back up pacing. Therapies are compared in a prospective, randomized, single-blinded, parallel trial with a 24-month randomized treatment period. Randomization follows a 1:1 ratio. ICD therapy is enabled for all patients throughout the study. All patients receive optimal drug therapy for arrhythmia and heart failure treatment.
Detailed description
All patients will receive an implantable cardioverter defibrillator OVATIO™ DR model 6550 or a later Sorin Group device offering the same functions. After Enrolment visit but before implant, patients will be randomized in two arms according to the parallel study design. Whenever possible before implant there will be the first Holter recording for the Tvar risk stratification procedure. In case Tvar recording could not be performed before implant it has to be performed before patient leaves the hospital post implant in unpaced rhythm.
The dual-chamber arm will be programmed to 3 detection zones with PARAD+ activated.
The TDI for the slow VT zone will be set to 500 ms (120 bpm - or in case the resting rate is higher than 90 bpm it is recommended to adjust this parameter to: resting rate + 30 bpm) and at least one ATP program activated as specified in table 1.
A VT zone with a TDI of 353 ms (170 bpm) in case of no history of VT or a TDI cycle length equalling slowest documented VT interval (spontaneous or induced) plus 50 ms is required. In this 2nd VT zone therapies need to be activated in this group.
AAIsafeR2 mode will be activated with a basic rate of 60 bpm. The single-chamber arm will be programmed to optimal detection with Acceleration (Onset), Stability and Long Cycle Search (VTLC) activated. A VT zone is requested in this group, with the same programming procedures as described above. Therapies will be set according to the clinical judgment of the participating investigators but a Slow VT-zone with TDI 500 ms in monitoring setting at least is required.
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 DR 6550Dual-chamber detection and activated treatment (at least ATP) in the slow VT-zone plus activated AAIsafeR pacing (basic rate 60 bpm). |
| 2 | Experimental | Device: OVATIO DR 6550Single-chamber ICD following clinical practice but with a monitoring zone active to allow the documentation of all occurring ventricular arrhythmias |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient has been prescribed the implantation for an ICD system accordingly to the relevant currently-approved ACC/AHA guidelines 1 or ESC guidelines 35 or any relevant currently-approved local guidelines for the implantation of an ICD-system
- Impaired left ventricular function demonstrated by a left-ventricular ejection fraction (LVEF) ≤ 40 %, measured by angio-scintigraphy, echocardiography, or contrast ventriculogram.
- An optimal (as determined by the enrolling physician) medical regimen.
- Patient has received all relevant information on the study, and has signed and dated a consent form.
Key exclusion criteria (18 listed)
- Any generally accepted indication for standard cardiac pacing, or any contraindication for standard cardiac pacing.
- Any indication for CRT accordingly to the relevant currently-approved ACC/AHA1 or ESC35 guidelines for the implantation of a CRT system.
- Any contraindication for ICD therapy and the implant of a dual chamber ICD.
- ICD replacement
- Chronic atrial arrhythmias or cardioversion for atrial fibrillation within the past month.
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 DR 6550Dual-chamber ICD therapy with minimized ventricular pacing | Device | 1 |
| OVATIO DR 6550Single-chamber device therapy with settings which are common in clinical practice. | Device | 2 |
Primary outcome
The first part is the time to first occurrence of inappropriate ICD shock therapy. The second part is the composite endpoint of time to first occurrence of death (all causes)or Hospitalizations due to cardio-vascular event.
Time frame: implant, 3 months, 9 months, 15 months, 21 months and 27 months
15 secondary outcomes
all cause mortality and cardio-vascular related mortality
Time frame: 27 months follow up
Hospitalizations due to cardio-vascular event (specified for each type of event)
Time frame: 27 months follow up
Time to first occurrence of inappropriate ICD shock therapy
Time frame: 27 months follow up
Evaluation of the impact of the different therapies on quality of life and heart failure status
Time frame: 27 months follow up
Sensitivity and specificity for VT/SVT discrimination for the first 100 patients in each group.
Time frame: 27 months
Inappropriate overall device reactions defined by inappropriate shock and/or ATP therapy or inappropriate therapy delay/inhibition > 2 minutes on VTs
Time frame: 27 months
time to first documented AF occurrence and number of patients moving into permanent or persistent AF
Time frame: 27 months follow up
Cardiac dimensions obtained by echo evaluation for a subset of patients of both groups
Time frame: Baseline and 27 months
Slow VT incidence
Time frame: 27 months
Unscheduled visits and hospitalizations due to slow VT
Time frame: 27 months follow up
System related complications including lead dislodgements, exit block, oversensing which requires programming corrections, infections, complications which require reintervention
Time frame: 27 months follow up
Cumulative percentage of ventricular pacing and proportion of patients with 0% V pacing.
Time frame: 27 months follow up
Overall success rate of ATP in the FVT zone
Time frame: 27 months
Cost effectiveness of applied ICD therapy
Time frame: 27 months
PPV and NPV for Tvar risk stratification
Time frame: 27 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 13 Jan 2015.
- Background: PubMed 20487351Kolb C, Tzeis S, Sturmer M, Babuty D, Schwab JO, Mantovani G, Janko S, Aime E, Ocklenburg R, Sick P. Rationale and design of the OPTION study: optimal antitachycardia therapy in ICD patients without pacing indications. Pacing Clin Electrophysiol. 2010 Sep;33(9):1141-8. doi: 10.1111/j.1540-8159.2010.02790.x.
- Results publication: PubMed 25282033Kolb C, Sturmer M, Sick P, Reif S, Davy JM, Molon G, Schwab JO, Mantovani G, Dan D, Lennerz C, Borri-Brunetto A, Babuty D. Reduced risk for inappropriate implantable cardioverter-defibrillator shocks with dual-chamber therapy compared with single-chamber therapy: results of the randomized OPTION study. JACC Heart Fail. 2014 Dec;2(6):611-9. doi: 10.1016/j.jchf.2014.05.015. Epub 2014 Oct 1.
Related trials for Tachycardia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruiting
HEAL-IST IDE Trial
Inappropriate Sinus Tachycardia
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
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.
Kolb principal investigator
Deutsches Herzzentrum München
55 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 DR 6550 in people with Tachycardia, run by LivaNova at 55 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 4 inclusion and 18 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 13 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in Germany, France, United States, Italy, Belgium 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?
The first part is the time to first occurrence of inappropriate ICD shock therapy. The second part is the composite endpoint of time to first occurrence of death (all causes)or Hospitalizations due to cardio-vascular event. (time frame: implant, 3 months, 9 months, 15 months, 21 months and 27 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00729703, which also lists 2 linked publications.
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 13 Jan 2015.