Therapy Cool Path Ablate VT

Stopped early · Not applicable

Conditions studied: Ischemic Ventricular Tachycardia

In brief

To demonstrate that ablation with the Therapy Cool Path Duo cardiac ablation system can eliminate ischemic VT and that its use does not result in an unacceptable risk of serious adverse events.

Key facts

Study ID: NCT00925522
Run by: Abbott Medical Devices
People needed: 20
Starts: 2009-06-01
Expected to finish: 2011-07-01
Last updated by the study team: 2019-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient is 18 years of age or older
Patient has an ICD (Implantable Cardiac Defibrillator) or will be implanted with one prior to discharge of ablation procedure
Patient has had at least 2 documented spontaneous episode of sustained ischemic VT (Ventricular Tachycardia) within the previous 6 months
Patient is resistant, intolerant or refractory to at least one Class I or III AAD (Anti-Arrhythmic Drug)
Patient has been informed of the nature of the study and has agreed to its provisions and provided written informed consent approved by the Institutional Review Board

You may not qualify if…

Non-ischemic VT
History of stroke or transient ischemic attack within 6 months prior to enrollment
MI or previous cardiac surgery within 2 months prior to enrollment
Patient is pregnant or nursing
Patient has chronic NYHA (New York Heart Association) class IV heart failure
Limited life expectancy of 6 months or less
Patient is currently participating in another investigational drug or device study
Patient is unable or unwilling to cooperate with the study procedures
Known presence of intracardiac thrombi
Severe aortic stenosis or flailed mitral valve
Major contraindication to anticoagulation therapy or coagulation disorder
Left Ventricular Ejection Fraction <10%

Where it is running

University Hospital - Univ. of Alabama at Birmingham (UAB) — Birmingham, Alabama, United States
Loyola University Medical Center — Maywood, Illinois, United States
Krannert Institute of Cardiology — Indianapolis, Indiana, United States
Kansas University Medical Center — Kansas City, Kansas, United States
Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.