Fast VT Episodes Are Terminated by ATP One Shot

Ventricular Tachycardia, Monomorphic Clinical Trial

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Official title:

Fast VT Episodes Are Terminated by ATP One Shot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00617578
• Other study ID #: TA080
• Status: Completed
• Phase: Phase 4
• First received: February 6, 2008
• Last updated: December 18, 2013
• Start date: November 2007
• Est. completion date: July 2012

Study information

• Verified date: May 2012
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia, Monomorphic

Intervention

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
• ATP One Shot OFF
Standard defibrillation shock delivery

Locations

Country	Name	City	State
Austria	Medizinische Abteilung, LKH Bruck	Bruck / Mur
Austria	Innere Medizin - Kardiologie, Universitätsklinik Innsbruck	Innsbruck
Austria	Med. Abteilung, AKH Linz	Linz
Finland	Cardiology, Satakunta Central Hospital	Pori
Germany	Klinik für Innere Medizin, Vivantes Humboldt Klinikum	Berlin
Germany	Medizinische Klinik II, Universitätsklinikum Bonn	Bonn
Germany	Medizinische Klinik I, Ev. Krankenhaus	Holzminden
Germany	Medizinische Klinik, Kreiskrankenhaus	Neustadt / Aisch
Germany	Kardiologie, DRK Krankenhaus Mölln	Ratzeburg
Germany	Kardiologische Praxis Dr. Placke	Rostock
Germany	Innere Medizin - Kardiologie, Klinikum Uckermark	Schwedt / Oder
Germany	Kliniken Villingen Schwenningen, Klinik für Innere Medizin III, Kardiologie	Villingen
Germany	Medizinische Klinik I, St-Josefs-Hospital	Wiesbaden
Israel	Cardiology, Rabin MC	Petach-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Austria,  Finland,  Germany,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to the first adequate device shock		18 months	Yes
Secondary	Quality of Life		18 months	No
Secondary	Duration of Episodes		18 months	Yes