Trials Sponsors Conditions Drugs Pricing

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 SystemDevice

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Abbott Medical Devices
Industrylead

Study Sites (5)

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

Birmingham, Alabama, 35233, United States

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Krannert Institute of Cardiology

Indianapolis, Indiana, 46202, United States

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Results Point of Contact

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

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

Enrollment

20 participants (actual enrollment reported by the registry).

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 2009

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

Therapy Cool Path Ablate VT

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Therapy Cool Path Duo Cardiac Ablation System

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Therapy Cool Path Duo Cardiac Ablation System

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations