- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00729703
Optimal Anti-tachycardia Therapy in Implantable Cardioverter-defibrillator (ICD) Patients Without Pacing Indications (OPTION)
Optimal Antitachycardia Therapy in ICD Patients Without Pacing Indications
Study Overview
Status
Conditions
Intervention / 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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Antwepen, Belgium, 2600
- Algemeen Ziekenhuis - Antwepen
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Gent, Belgium, 9050
- Kliniek Maria Middelares - Gent
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Hasselt, Belgium, 3500. 64
- Heart Center Virga Jesse Ziekenhuis - Hasselt
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Montreal, Canada
- Hopital Sacre Coeur
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Montreal, Canada, H4Y 1H1
- CHUM Hôtel-Dieu
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Aix-en-Provence, France
- Centre Hospitalier General
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Bordeaux, France, 33000
- CHU Le Haut L'Evêque
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Grenoble, France
- CHU Hôpital Michallon Grenoble
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Le Chesnay, France, 78150
- Clinique de Parly II
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Le Mans, France
- Clinique les sources
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Lomme, France
- CH St Philibert
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Lyon, France, 69000
- Hôpital St Joseph
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Montpellier, France, 34294
- Hôpital Arnaud De Villeneuve
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Nantes, France, 44000
- CHU Nantes
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Paris, France, 75016
- Clinique BIZET
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Pau, France, 64000
- CH Pau
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Rouen, France, 76000
- CHU Charles Nicolle
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Toulouse, France, 31000
- Clinique Pasteur
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Toulouse, France, 31000
- Hopital Rangueil
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Toulouse, France
- CHU Purpan Toulouse
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Tours, France
- CHU Tours
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Bad Bevensen, Germany
- Herzkreislaufklinik
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Bad Nauheim, Germany, 61231
- Kerckhoff Klinik
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Berlin, Germany, 13353
- Charite Campus Virchow
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Bonn, Germany
- Universitatskliniken Bonn
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Coburg, Germany, 96465
- Klinikum Coburg
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Garmisch-Partenkirchen, Germany, 82467
- Klinikum Garmisch-Partenkirchen
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Hamburg, Germany, 2100
- Universitätsklinikum Hamburg-Eppendorf
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Homburg, Germany
- Universität des Saarlandes
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Lübeck, Germany, 23501
- Universitätsklinikum Schleswig-Holstein Campus Lübeck
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Munchen, Germany
- Klinikum rechts der Isar
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Munchen, Germany
- Klinikum Bogenhausen
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Munchen, Germany
- DHZ München
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Munster, Germany
- Uniklinik Münster
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München, Germany, 80337
- Kardiologische Gemeinschaftspraxis
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München, Germany, 81000
- Universitätsklinikum Großhadern
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Regensburg, Germany, 93047
- Klinikum der Universität Regensburg
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Regensburg, Germany, 93047
- Krankenhaus der Barmherzigen Brüder
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ULM, Germany
- Universitätsklinik Ulm
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Desio, Italy, 20033
- Ospedale Civile
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Negrar, Italy
- Ospedale Sacro Cuore Don Calabria
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Pavia, Italy, 27100
- Casa Di Cura Citta Di Pavia
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San Donato, Italy
- Policlinico San Donato
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San Donato Milanese, Italy, 20097
- Ospedale Clinicizzato San Donato
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Amsterdam, Netherlands, 1060
- Onze Lieve Vrouwen Gasthuis
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Almada, Portugal
- Hospital Garcia de Orta
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Guimaraes, Portugal
- Hospital Senhora da Oliveira
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London, United Kingdom
- St Peters Hospital
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Taunton, United Kingdom, TA1 4DY
- Musgrove Park Hospltal
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Worthing, United Kingdom, NR20 4LB
- Worthing And Southlands Hospital
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Georgia
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Atlanta, Georgia, United States, 30303
- Piedmont Hospital Research Institute
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Decatur, Georgia, United States, 30301
- Atlanta VA Medical Center
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Louisiana
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Mandeville, Louisiana, United States, 70471
- Southern Medical Research, LLC
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Ohio
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Jeffersonville, Ohio, United States, 43128
- River City Cardiology
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South Carolina
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Florence, South Carolina, United States, 29501
- Pee Dee Cardiology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: 1
Dual-chamber detection and activated treatment (at least ATP) in the slow VT-zone plus activated AAIsafeR pacing (basic rate 60 bpm).
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Dual-chamber ICD therapy with minimized ventricular pacing
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EXPERIMENTAL: 2
Single-chamber ICD following clinical practice but with a monitoring zone active to allow the documentation of all occurring ventricular arrhythmias
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Single-chamber device therapy with settings which are common in clinical practice.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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implant, 3 months, 9 months, 15 months, 21 months and 27 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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all cause mortality and cardio-vascular related mortality
Time Frame: 27 months follow up
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27 months follow up
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Hospitalizations due to cardio-vascular event (specified for each type of event)
Time Frame: 27 months follow up
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27 months follow up
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Time to first occurrence of inappropriate ICD shock therapy
Time Frame: 27 months follow up
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27 months follow up
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Evaluation of the impact of the different therapies on quality of life and heart failure status
Time Frame: 27 months follow up
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27 months follow up
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Sensitivity and specificity for VT/SVT discrimination for the first 100 patients in each group.
Time Frame: 27 months
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27 months
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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
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27 months
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time to first documented AF occurrence and number of patients moving into permanent or persistent AF
Time Frame: 27 months follow up
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27 months follow up
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Cardiac dimensions obtained by echo evaluation for a subset of patients of both groups
Time Frame: Baseline and 27 months
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Baseline and 27 months
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Slow VT incidence
Time Frame: 27 months
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27 months
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Unscheduled visits and hospitalizations due to slow VT
Time Frame: 27 months follow up
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27 months follow up
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System related complications including lead dislodgements, exit block, oversensing which requires programming corrections, infections, complications which require reintervention
Time Frame: 27 months follow up
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27 months follow up
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Cumulative percentage of ventricular pacing and proportion of patients with 0% V pacing.
Time Frame: 27 months follow up
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27 months follow up
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Overall success rate of ATP in the FVT zone
Time Frame: 27 months
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27 months
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Cost effectiveness of applied ICD therapy
Time Frame: 27 months
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27 months
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PPV and NPV for Tvar risk stratification
Time Frame: 27 months
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27 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kolb, Deutsches Herzzentrum Munchen
Publications and helpful links
General 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.
- Kolb 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPTION - ITAC03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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