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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT00617578
First received: February 6, 2008
Last updated: December 18, 2013
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Ventricular Tachycardia, Monomorphic
Device: ATP One Shot ON
Device: ATP One Shot OFF
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fast VT Episodes Are Terminated by ATP One Shot

Resource links provided by NLM:


Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • Time to the first adequate device shock [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Duration of Episodes [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Enrollment: 194
Study Start Date: November 2007
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
programming of VF therapy: ATP (antitachycardia pacing) One Shot ON
Device: ATP 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
Device: ATP One Shot OFF
Standard defibrillation shock delivery

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617578

Locations
Austria
Medizinische Abteilung, LKH Bruck
Bruck / Mur, Austria, 8600
Innere Medizin - Kardiologie, Universitätsklinik Innsbruck
Innsbruck, Austria, 6020
Med. Abteilung, AKH Linz
Linz, Austria, 4020
Finland
Cardiology, Satakunta Central Hospital
Pori, Finland, 28100
Germany
Klinik für Innere Medizin, Vivantes Humboldt Klinikum
Berlin, Germany, 13509
Medizinische Klinik II, Universitätsklinikum Bonn
Bonn, Germany, 53105
Medizinische Klinik I, Ev. Krankenhaus
Holzminden, Germany, 37603
Medizinische Klinik, Kreiskrankenhaus
Neustadt / Aisch, Germany, 91413
Kardiologie, DRK Krankenhaus Mölln
Ratzeburg, Germany, 23909
Kardiologische Praxis Dr. Placke
Rostock, Germany, 18107
Innere Medizin - Kardiologie, Klinikum Uckermark
Schwedt / Oder, Germany, 16284
Kliniken Villingen Schwenningen, Klinik für Innere Medizin III, Kardiologie
Villingen, Germany
Medizinische Klinik I, St-Josefs-Hospital
Wiesbaden, Germany, 65189
Israel
Cardiology, Rabin MC
Petach-Tikva, Israel, Israel
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
Study Chair: Jörg Otto Schwab, PD Dr. University Hospital Bonn, Germany
  More Information

No publications provided

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT00617578     History of Changes
Other Study ID Numbers: TA080
Study First Received: February 6, 2008
Last Updated: December 18, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biotronik SE & Co. KG:
Antitachy pacing
Implantable cardioverter-defibrillator

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014