Fast VT Episodes Are Terminated by ATP One Shot (FavoriteATP)

December 18, 2013 updated by: Biotronik SE & Co. KG

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

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

Interventional

Enrollment (Actual)

194

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Jörg Otto Schwab, PD Dr., University Hospital Bonn, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

February 6, 2008

First Submitted That Met QC Criteria

February 15, 2008

First Posted (Estimate)

February 18, 2008

Study Record Updates

Last Update Posted (Estimate)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

May 1, 2012

More Information

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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