Therapy Cool Path Ablate VT

NCT00925522 | Terminated Results

• 1 other identifier: G080076
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Ischemic Ventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

• Primary Safety is Defined as the Incidence of Intra-procedural, Acute or Sub-chronic, Serious Cardiac Adverse Events, up to 7 Days Post-procedure.

  7 days

Study Arms (1)

Therapy Cool Path Duo Cardiac Ablation System

EXPERIMENTAL

All patients who are eligible receive cardiac ablation procedure for Ischemic Ventricular Tachycardia

Device: Therapy Cool Path Duo Cardiac Ablation System

Interventions

Therapy Cool Path Duo Cardiac Ablation System DEVICE

Cardiac Ablation Procedure for Ischemic VT using a flexible, insulated 7F all braided catheter that contains an internal lumen connected to 12 open conduits at the 4mm tip electrode for infusion of heparinized saline during radiofrequency ablation; records intracardiac electrograms and can be utilized for cardiac simulation during diagnostic electrophysiologic studies/evaluation. 1500T9-VT generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The Generator will be used in Temperature Control mode only. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode.

Therapy Cool Path Duo Cardiac Ablation System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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%

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (5)

University Hospital - Univ. of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35233, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Krannert Institute of Cardiology

Indianapolis, Indiana, 46202, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Results Point of Contact

• Title: Nancy Ouch, Project Manager
• Organization: St. Jude Medical

nouch@sjm.com

949.769.5041

Study Officials

• G. Neal Kay, M.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2009
• First Posted: June 22, 2009
• Study Start: June 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: July 1, 2011
• Last Updated: April 17, 2019
• Results First Posted: May 27, 2016

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)