NCT00617578

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2007

Longer than P75 for phase_4

Geographic Reach
4 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 18, 2008

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

December 19, 2013

Status Verified

May 1, 2012

Enrollment Period

4.7 years

First QC Date

February 6, 2008

Last Update Submit

December 18, 2013

Conditions

Ventricular Tachycardia, Monomorphic

Keywords

Antitachy pacingImplantable cardioverter-defibrillator

Outcome Measures

Primary Outcomes (1)

  • Time to the first adequate device shock

    18 months

Secondary Outcomes (2)

  • Quality of Life

    18 months

  • Duration of Episodes

    18 months

Study Arms (2)

1

EXPERIMENTAL

programming of VF therapy: ATP (antitachycardia pacing) One Shot ON

Device: ATP One Shot ON

2

ACTIVE COMPARATOR

programming of VF therapy: ATP (antitachycardia pacing) One Shot OFF

Device: ATP One Shot OFF

Interventions

ATP One Shot ONDEVICE

The new antitachycardia pacing algorithm "ATP One Shot" attempts to terminate fast VT by one ATP sequence and thus avoid defibrillation shock delivery

1
ATP One Shot OFFDEVICE

Standard defibrillation shock delivery

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ICD indication for reason of survived cardiac arrest, ventricular tachycardia or syncope

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Medizinische Abteilung, LKH Bruck

Bruck / Mur, 8600, Austria

Location

Innere Medizin - Kardiologie, Universitätsklinik Innsbruck

Innsbruck, 6020, Austria

Location

Med. Abteilung, AKH Linz

Linz, 4020, Austria

Location

Cardiology, Satakunta Central Hospital

Pori, 28100, Finland

Location

Klinik für Innere Medizin, Vivantes Humboldt Klinikum

Berlin, 13509, Germany

Location

Medizinische Klinik II, Universitätsklinikum Bonn

Bonn, 53105, Germany

Location

Medizinische Klinik I, Ev. Krankenhaus

Holzminden, 37603, Germany

Location

Medizinische Klinik, Kreiskrankenhaus

Neustadt / Aisch, 91413, Germany

Location

Kardiologie, DRK Krankenhaus Mölln

Ratzeburg, 23909, Germany

Location

Kardiologische Praxis Dr. Placke

Rostock, 18107, Germany

Location

Innere Medizin - Kardiologie, Klinikum Uckermark

Schwedt, 16284, Germany

Location

Kliniken Villingen Schwenningen, Klinik für Innere Medizin III, Kardiologie

Villingen, Germany

Location

Medizinische Klinik I, St-Josefs-Hospital

Wiesbaden, 65189, Germany

Location

Cardiology, Rabin MC

Petah Tikva, Israel, Israel

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jörg Otto Schwab, PD Dr.

    University Hospital Bonn, Germany

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2008

First Posted

February 18, 2008

Study Start

November 1, 2007

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

December 19, 2013

Record last verified: 2012-05

Locations

DE(9)IL(1)AU(3)FI(1)