Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00170287
Other study ID # CEN_G_CA_3
Secondary ID
Status Completed
Phase Phase 4
First received September 9, 2005
Last updated September 5, 2017
Start date May 2002
Est. completion date August 2011

Study information

Verified date September 2017
Source Medtronic Bakken Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The present standard of care for the management of unstable ventricular tachycardia (VT) in the setting of chronic coronary artery disease is the placement of an implantable cardioverter defibrillator (ICD) after the initial episode, and radiofrequency ablation and/or antiarrhythmic medication in the event of recurrences causing frequent ICD interventions.

The primary purpose of this randomized study is the assessment of recurrences of unstable VT in patients who undergo ICD implantation plus substrate ablation after the initial episode compared to patients who only undergo ICD implantation. Thus the primary purpose is an improvement in the quality of life. A decrease in mortality is not a primary purpose of this study.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date August 2011
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Coronary artery disease documented by coronary angiography. For the purpose of this study, coronary artery disease will be defined as the presence of a 50% or more diameter stenosis of the left main or of a 75% or more diameter stenosis of the left anterior descending, circumflex or right coronary arteries, or the history of a surgical or percutaneous revascularization procedure.

- Left ventricular ejection fraction < 40% as estimated by echocardiography or contrast ventriculography within the previous 30 days.

- Clinical unstable VT without reversible factors (acute ischemia or antiarrhythmic medications as defined below). Unstable VT can have one of the following clinical presentations:

- Hypotensive VT without major neurologic dysfunction;

- Syncope; or

- Cardiac arrest.

Exclusion Criteria:

- Age < 18 years or > 80 years

- Protruding left ventricular (LV) thrombus on pre-ablation echocardiogram

- Acute myocardial infarction within the preceding 2 months

- Class IV New York Heart Association (NYHA) heart failure

- Valvular heart disease or mechanical heart valve precluding access to the left ventricle

- Unstable angina

- Cardiac surgery within the past 2 months

- Serum creatinine > 220 mmol/L (2.5 mg/dL)

- Thrombocytopenia or coagulopathy

- Contraindication to heparin

- Pregnancy

- Acute illness or active systemic infection

- Other disease process likely to limit survival to less than 12 months

- Significant medical problem that, in the opinion of the principal investigator, would preclude enrollment into the study

- Participation in another investigational study

- Unwillingness to participate or lack of availability for follow-up

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
ICD Ablation plus VT-ablation
ICD-Therapy for the treatment of unstable VT´s plus catheter ablation for substrate modification
Device:
ICD Therapy
ICD Therapy for the Treatment of unstable VT´s

Locations

Country Name City State
Denmark Skejby Skygehus Aarhus
Germany Herz- und Gefäßklinik GmbH Bad Neustadt / Saale
Germany Berufsgenossenschaftliche Kliniken Bergmannsheil Bochum
Germany Klinikum der J.W. Goethe Universität Frankfurt
Germany Allgemeines Krankenhaus St. Georg Hamburg
Germany Universitätsklinikum Hamburg-Eppendorf Hamburg
Germany Klinikum der Stadt Ludwigshafen am Rhein Ludwigshafen

Sponsors (2)

Lead Sponsor Collaborator
Medtronic Bakken Research Center Medtronic

Countries where clinical trial is conducted

Denmark,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to the first documented recurrence of any sustained VT/ventricular fibrillation (VF) during the follow-up period 12 Months
Secondary All appropriate ICD therapies (number of shocks, number of antitachycardia pacing therapies) 12 Months
Secondary Quality of life 12 Months
Secondary Number of hospital readmissions due to a cardiac indication 12 Months
Secondary Severe clinical events 12 Months
See also
  Status Clinical Trial Phase
Terminated NCT01546207 - Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia N/A
Completed NCT04075253 - Acute Effect of One Single Bout of High Intensity Exercise on the Tendency for Ventricular Arrhythmia N/A
Completed NCT04070300 - Physical Activity and Ventricular Arrhythmias N/A
Completed NCT00000531 - Antiarrhythmics Versus Implantable Defibrillators (AVID) Phase 3
Completed NCT00000480 - Multicenter Unsustained Tachycardia Trial (MUSTT) Phase 3
Completed NCT05086510 - Ablation Targets of Scar-related Ventricular Tachycardia Identified by Dynamic Functional Substrate Mapping N/A
Completed NCT01940081 - The Leiden Nonischemic Cardiomyopathy Study
Recruiting NCT01222156 - Accuracy and Safety Study of the Magnetecs CGCI System for Intracardiac Mapping Phase 1/Phase 2
Terminated NCT00749671 - Bispectral Index Monitoring During Testing in the Electrophysiology Lab N/A
Recruiting NCT00385749 - Right Ventricular Defibrillation Lead Select Site Study N/A
Completed NCT00382928 - Automatic External Defibrillation Monitoring in Cardiac Arrest Phase 1
Completed NCT00279279 - PREPARE - Primary Prevention Parameters Evaluation N/A
Terminated NCT00776087 - European Health Economic Trial on Home Monitoring in ICD and CRT-D Patients (EuroEco) N/A
Withdrawn NCT00510731 - The Ability Of The PD2i Cardiac Analyzer To Predict Risk Of Ventricular Tachyarrhythmic Events N/A
Completed NCT01572246 - Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators N/A
Completed NCT00147277 - ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy Phase 4
Completed NCT00004559 - Fatty Acid Antiarrhythmia Trial (FAAT) Phase 3
Completed NCT00702117 - Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias Phase 4
Completed NCT00232297 - Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of SSR149744c 100 or 300 mg for the Prevention of ventrICular ARrhythmia-triggered Icd interventiOnS Phase 2
Active, not recruiting NCT01639365 - SmartTouch Catheter in Ablation of Ventricular Tachycardia N/A