Clinical Evaluation of Therapy Cool Path Duo Cardiac Ablation System for the Treatment of Ischemic Ventricular Tachycardia (VT) (Ablate-VT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00925522
First received: June 8, 2009
Last updated: January 3, 2014
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Ischemic Ventricular Tachycardia
Device: Therapy Cool Path Duo Cardiac Ablation System
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Therapy Cool Path Duo Cardiac Ablation System for the Treatment of Ischemic Ventricular Tachycardia (VT)

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Primary Safety is defined as the incidence of intra-procedural, acute or sub-chronic, serious cardiac adverse events, up to 7 days post-procedure. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Acute Success is achieved when all clinically relevant VT substrates (spontaneous and induced VT episodes) are terminated and no longer inducible upon hospital discharge (i.e., last study ablation procedure prior to hospital discharge). [ Time Frame: Hospital Discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Chronic Success is defined at 6 months following the RF ablation procedure as no recurrence of clinically relevant VT(s) that were targeted at ablation. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: June 2009
Study Completion Date: July 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Therapy Cool Path Duo Cardiac Ablation System Device: Therapy Cool Path Duo Cardiac Ablation System

Consists of the following three system components:

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.

The 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.

The Cool Point ™ Irrigation Pump and Cool Point™ Tubing Set is an external volumetric pump that is intended for use in administration of general I.V. fluids to patient's vascular system through the catheter in the hospital environment.


Detailed Description:

Ventricular Tachycardia (VT) is a common complication of ischemic heart disease that is often life threatening. Ventricular tachycardia is defined as three or more beats of ventricular origin in succession at a rate greater than 100 beats per minute. There are no normal QRS complexes associated with VT, and the rhythm is usually regular. Patients with VT experience unpleasant heart palpitations, dyspnea, and syncope, all of which decrease their overall quality of life. They also suffer the consequences of impaired hemodynamics, loss of cardiac efficiency, and are at an increased risk of sudden cardiac death (SCD), which accounts for approximately half of all deaths from patients with cardiovascular disease.

Historically, antiarrhythmic medications served as the first line therapy for the treatment of VT, in spite of low efficacy and high recurrence rates. But in recent years, internal cardioverter defibrillators (ICDs) have become the treatment of choice. Although, ICDs are effective in terminating most arrhythmias, rarely does so without some episodes requiring poorly tolerated shock therapy. Ablative therapy offers an important option for frequent control with the potential for long-term VT elimination. Radiofrequency catheter ablation offers the ability to provide immediate control of recurrent VT. Since the early 2000's, strategies, tools, and techniques have been improving to identify key ablation sites and to deliver effective lesions.

Radiofrequency ablation is successful in treating some but not all arrhythmias. With non irrigated technology it has been difficult to ablate ischemic VT. This may be due to an inadequate lesion size. Irrigated electrodes were developed to create larger lesions. Open irrigation at the catheter tip not only produces larger lesions, but also helps reduce the risk of coagulum (clots) and charring due to high temperatures.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is 18 years of age or older
  • Patient has an ICD 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 within the previous 6 months
  • Patient is resistant, intolerant or refractory to at least one Class I or III AAD
  • 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

Exclusion Criteria:

  • 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 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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925522

Locations
United States, Alabama
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States, 35233
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Indiana
Krannert Institute of Cardiology
Indianapolis, Indiana, United States, 46202
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: G. Neal Kay, M.D. University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00925522     History of Changes
Other Study ID Numbers: G080076
Study First Received: June 8, 2009
Last Updated: January 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ischemia
Tachycardia
Tachycardia, Ventricular
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014