- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00617578
Fast VT Episodes Are Terminated by ATP One Shot (FavoriteATP)
Many arrhythmias detected in the ventricular fibrillation (VF)-zone picture monomorphic ventricular tachycardia (VT) and, hence, could be terminated by antitachycardia pacing (ATP) treatment. Advantages of successful ATP are the painlessness termination and the shortened duration of arrhythmia. The ATP One Shot algorithm is integrated in the latest family of implantable cardioverter defibrillators (ICDs) from BIOTRONIK (Lumax). It allows a single delivery of ATP before charging capacitors to terminate lethal arrhythmia by painful shock.
The present study evaluates the efficacy of the ATP One Shot algorithm for the termination of fast VT episodes. 200 patients with secondary prophylactic ICD indication will be followed for 18 months. Spontaneous episodes detected in the VF-zone of the ICD will be evaluated with regard to cycle length, episode duration and course of device therapy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
ICDs provide different detection zones for the therapy of VT and VF. An established form of therapy in the VT-zone is antitachycardia pacing (ATP). It is an effective, safe and painless method to terminate episodes of slow VT with a cycle length > 300 ms. Episodes detected in the VF zone will result in the delivery of a high-energy shock to terminate life-threatening VF. Many arrhythmia detected in the VF-zone picture monomorphic VT and could be easily terminated by ATP. Advantages of a successful termination by ATP therapy would be the painlessness and the shortened duration of the episode, as there would be no need to load shock capacitors. Fast VT are often hemodynamically poorly tolerated by the patient and should be terminated within very short time. The ATP One Shot algorithm is integrated in the latest family of ICDs from BIOTRONIK (Lumax) to allow a single delivery of ATP before charging capacitors.
The main objective of the study is the assessment of the efficacy of the ATP One Shot algorithm for the termination of fast VT episodes. To this end, spontaneous episodes detected in the VF-zone of the ICD are evaluated with regard to cycle length, episode duration and course of device therapy. In the context of the study, a confirmatory (hypothesis-testing) primary problem is investigated. The goal is to measure the time to first adequate shock therapy for episodes detected in the VF-zone of the device and to analyze the hazard ratio of the standard ICD setting compared to a therapy with the ATP One Shot algorithm.
The clinical project is conducted as randomized prospective multicenter study. The chronological order and the scope of the follow-ups meet the medical standard according to the international guidelines. A center-based, stratified block randomization will be performed. In approximately 50% of the patients the ATP One Shot algorithm will be activated, while the other 50% will be randomized into the control group.
A total of about 20 European investigational sites will participate in the study. Each center should enroll about 10 patients who will be followed for 18 months.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Bruck / Mur, Austria, 8600
- Medizinische Abteilung, LKH Bruck
-
Innsbruck, Austria, 6020
- Innere Medizin - Kardiologie, Universitätsklinik Innsbruck
-
Linz, Austria, 4020
- Med. Abteilung, AKH Linz
-
-
-
-
-
Pori, Finland, 28100
- Cardiology, Satakunta Central Hospital
-
-
-
-
-
Berlin, Germany, 13509
- Klinik für Innere Medizin, Vivantes Humboldt Klinikum
-
Bonn, Germany, 53105
- Medizinische Klinik II, Universitätsklinikum Bonn
-
Holzminden, Germany, 37603
- Medizinische Klinik I, Ev. Krankenhaus
-
Neustadt / Aisch, Germany, 91413
- Medizinische Klinik, Kreiskrankenhaus
-
Ratzeburg, Germany, 23909
- Kardiologie, DRK Krankenhaus Mölln
-
Rostock, Germany, 18107
- Kardiologische Praxis Dr. Placke
-
Schwedt / Oder, Germany, 16284
- Innere Medizin - Kardiologie, Klinikum Uckermark
-
Villingen, Germany
- Kliniken Villingen Schwenningen, Klinik für Innere Medizin III, Kardiologie
-
Wiesbaden, Germany, 65189
- Medizinische Klinik I, St-Josefs-Hospital
-
-
-
-
-
Petach-Tikva, Israel, Israel
- Cardiology, Rabin MC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ICD indication for reason of survived cardiac arrest, ventricular tachycardia or syncope
Exclusion Criteria:
- ICD indication for reason of non-sustained VT post MI, positive family history for SCD (Brugada-, long/short QT-Syndrome), hypertrophic cardiomyopathy, primary prophylactic indication (e.g. SCD-HeFT, Madit II)
- Patients not capable of participating in the follow-ups
- Minors and pregnant women
- Patients who are already enrolled in another study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
programming of VF therapy: ATP (antitachycardia pacing) One Shot ON
|
The new antitachycardia pacing algorithm "ATP One Shot" attempts to terminate fast VT by one ATP sequence and thus avoid defibrillation shock delivery
|
Active Comparator: 2
programming of VF therapy: ATP (antitachycardia pacing) One Shot OFF
|
Standard defibrillation shock delivery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to the first adequate device shock
Time Frame: 18 months
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of Life
Time Frame: 18 months
|
18 months
|
Duration of Episodes
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jörg Otto Schwab, PD Dr., University Hospital Bonn, Germany
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
- TA080
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.
Clinical Trials on Ventricular Tachycardia, Monomorphic
-
Hospital General Universitario Gregorio MarañonCompletedMonomorphic Ventricular TachycardiaSpain
-
Abbott Medical DevicesTerminatedMonomorphic Ventricular TachycardiaUnited States, United Kingdom, France, Australia, Italy
-
Abbott Medical DevicesWithdrawn
-
Adagio MedicalActive, not recruitingMonomorphic Ventricular TachycardiaNetherlands, Czechia, Canada, Belgium, France, Germany
-
Fundación Hospital de MadridCompletedSustained Monomorphic Ventricular TachycardiaSpain
-
CardioSolv Ablation TechnologiesTerminatedIschemic Monomorphic Ventricular TachycardiaUnited States
-
Imperial College LondonWithdrawnMyocardial Infarction | Dilated Cardiomyopathy | Monomorphic Ventricular TachycardiaUnited Kingdom
-
University of PretoriaCompletedSupra-ventricular TachycardiaSouth Africa
-
Ottawa Heart Institute Research CorporationNot yet recruitingVentricular Fibrillation | Ventricular Tachycardia | Ventricular Arrhythmias | Recurrent Ventricular Tachycardia
-
Armgo Pharma, Inc.Food and Drug Administration (FDA)RecruitingCatecholaminergic Polymorphic Ventricular Tachycardia Type 1United States, Netherlands
Clinical Trials on ATP One Shot ON
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...CompletedSupraspinatus TendinitisItaly
-
Jiangsu Province Centers for Disease Control and...Completed
-
Shanghai Institute Of Biological ProductsCompleted
-
Case Comprehensive Cancer CenterNational Institute on Minority Health and Health Disparities (NIMHD)CompletedCancer Survivor | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast CancerUnited States
-
NYU Langone HealthNo longer availableComplex Abdominal Aortic AneurysmUnited States
-
Centre de Recherche de l'Institut Universitaire...Active, not recruitingUrinary Incontinence | Urinary Stress IncontinenceCanada
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health...CompletedOverweight and ObesityUnited States
-
Oregon Health and Science UniversityNational Cancer Institute (NCI); National Institute of Arthritis and Musculoskeletal...CompletedCardiovascular Diseases | Cancer | Physical Activity | NutritionUnited States
-
The Reading Hospital and Medical CenterCompletedAttitude of Health PersonnelUnited States
-
Universidad de ZaragozaCompletedCaregiver | Disabled Persons