Optimal Anti-tachycardia Therapy in Implantable Cardioverter-defibrillator (ICD) Patients Without Pacing Indications
- Conditions
- Tachycardia
- Interventions
- Device: OVATIO DR 6550
- Registration Number
- NCT00729703
- Lead Sponsor
- LivaNova
- Brief 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 462
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 OVATIO DR 6550 Dual-chamber detection and activated treatment (at least ATP) in the slow VT-zone plus activated AAIsafeR pacing (basic rate 60 bpm). 2 OVATIO DR 6550 Single-chamber ICD following clinical practice but with a monitoring zone active to allow the documentation of all occurring ventricular arrhythmias
- Primary Outcome Measures
Name Time Method 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. implant, 3 months, 9 months, 15 months, 21 months and 27 months
- Secondary Outcome Measures
Name Time Method Overall success rate of ATP in the FVT zone 27 months PPV and NPV for Tvar risk stratification 27 months Time to first occurrence of inappropriate ICD shock therapy 27 months follow up Cardiac dimensions obtained by echo evaluation for a subset of patients of both groups Baseline and 27 months Hospitalizations due to cardio-vascular event (specified for each type of event) 27 months follow up Evaluation of the impact of the different therapies on quality of life and heart failure status 27 months follow up Sensitivity and specificity for VT/SVT discrimination for the first 100 patients in each group. 27 months all cause mortality and cardio-vascular related mortality 27 months follow up Inappropriate overall device reactions defined by inappropriate shock and/or ATP therapy or inappropriate therapy delay/inhibition > 2 minutes on VTs 27 months time to first documented AF occurrence and number of patients moving into permanent or persistent AF 27 months follow up Slow VT incidence 27 months Unscheduled visits and hospitalizations due to slow VT 27 months follow up System related complications including lead dislodgements, exit block, oversensing which requires programming corrections, infections, complications which require reintervention 27 months follow up Cumulative percentage of ventricular pacing and proportion of patients with 0% V pacing. 27 months follow up Cost effectiveness of applied ICD therapy 27 months
Trial Locations
- Locations (55)
Pee Dee Cardiology
🇺🇸Florence, South Carolina, United States
River City Cardiology
🇺🇸Jeffersonville, Ohio, United States
CHU Le Haut L'Evêque
🇫🇷Bordeaux, France
CHU Charles Nicolle
🇫🇷Rouen, France
Southern Medical Research, Llc
🇺🇸Mandeville, Louisiana, United States
CHU Hôpital Michallon Grenoble
🇫🇷Grenoble, France
Clinique Bizet
🇫🇷Paris, France
Clinique De Parly II
🇫🇷Le Chesnay, France
Ospedale Sacro Cuore Don Calabria
🇮🇹Negrar, Italy
Universitätskliniken Bonn
🇩🇪Bonn, Germany
Universitätsklinik Ulm
🇩🇪ULM, Germany
CHUM Hotel-Dieu
🇨🇦Montreal, Canada
Hopital Arnaud De Villeneuve
🇫🇷Montpellier, France
Hôpital Rangueil
🇫🇷Toulouse, France
Policlinico San Donato
🇮🇹San Donato, Italy
Klinikum der Universität Regensburg
🇩🇪Regensburg, Germany
Hôpital Sacré Coeur
🇨🇦Montreal, Canada
Centre Hospitalier General
🇫🇷Aix-en-Provence, France
Hôpital St Joseph
🇫🇷Lyon, France
Klinikum rechts der Isar
🇩🇪Munchen, Germany
Casa Di Cura Citta Di Pavia
🇮🇹Pavia, Italy
Charite Campus Virchow
🇩🇪Berlin, Germany
Klinikum Garmisch-Partenkirchen
🇩🇪Garmisch-Partenkirchen, Germany
Worthing And Southlands Hospital
🇬🇧Worthing, United Kingdom
Clinique Pasteur
🇫🇷Toulouse, France
CHU Purpan Toulouse
🇫🇷Toulouse, France
CHU Nantes
🇫🇷Nantes, France
Onze Lieve Vrouwen Gasthuis
🇳🇱Amsterdam, Netherlands
Musgrove Park Hospltal
🇬🇧Taunton, United Kingdom
Universitatsklinikum Schleswig-Holstein Campus Lübeck
🇩🇪Lübeck, Germany
CH ST Philibert
🇫🇷Lomme, France
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Kerckhoff Klinik
🇩🇪Bad Nauheim, Germany
Ospedale Civile
🇮🇹Desio, Italy
DHZ Munchen
🇩🇪Munchen, Germany
Klinikum Bogenhausen
🇩🇪Munchen, Germany
Universitatsklinikum Grosshadern
🇩🇪München, Germany
St Peters Hospital
🇬🇧London, United Kingdom
CHU Tours
🇫🇷Tours, France
Herzkreislaufklinik
🇩🇪Bad Bevensen, Germany
Universität des Saarlandes
🇩🇪Homburg, Germany
Kliniek Maria Middelares - Gent
🇧🇪Gent, Belgium
Hospital Garcia de Orta
🇵🇹Almada, Portugal
Hospital Senhora da Oliveira
🇵🇹Guimaraes, Portugal
Ospedale Clinicizzato San Donato
🇮🇹San Donato Milanese, Italy
Piedmont Hospital Research Institute
🇺🇸Atlanta, Georgia, United States
Atlanta Va Medical Center
🇺🇸Decatur, Georgia, United States
Krankenhaus der Barmherzigen Brüder
🇩🇪Regensburg, Germany
Heart Center Virga Jesse Ziekenhuis - Hasselt
🇧🇪Hasselt, Belgium
Algemeen Ziekenhuis - Antwepen
🇧🇪Antwepen, Belgium
Clinique les sources
🇫🇷Le Mans, France
CH Pau
🇫🇷Pau, France
Klinikum Coburg
🇩🇪Coburg, Germany
Uniklinik Munster
🇩🇪Munster, Germany
Kardiologische Gemeinschaftspraxis
🇩🇪München, Germany