Back to results

Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia (CEASE-VT)

Primary Purpose

Defibrillators, Implantable, Tachycardia, Ventricular

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ablation

Amiodarone

About this trial

This is an interventional treatment trial for Defibrillators, Implantable focused on measuring Defibrillators, Implantable, Tachycardia, Ventricular, Catheter Ablation, Amiodarone

Eligibility Criteria

19 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria - Patients must meet all of the following criteria:

> 18 and < 85 years of age
ICD implanted for primary prophylaxis against sudden cardiac death or ICD implanted for secondary prophylaxis against spontaneous or inducible sustained VT without any reversible causes
Coronary artery disease (CAD) with prior myocardial infarction (MI)
ICD or electrocardiogram (ECG) documentation of ventricular arrhythmia responsible for appropriate ICD therapy [antitachycardia pacing (ATP) & shocks].

Exclusion Criteria - Patients should not have any of the following criteria:

Contraindication or allergy to contrast media, routine procedural medications or catheter materials
Contraindication to an interventional procedure
Current or previous (within 3 months) amiodarone therapy
Atrial Fibrillation requiring antiarrhythmic drug therapy
Contraindication to amiodarone therapy
New York Heart Association (NYHA) functional class IV
Myocardial infarction within the past 60 days
Stroke within the past 90 days
Unstable angina
Hypertrophic cardiomyopathy, Non-ischemic dilated cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Brugada Syndrome, Catecholamine sensitive polymorphic VT or long QT syndrome
Patients with active ischemia that are eligible for revascularization
Life expectancy less than 6 months
Incessant or multiple episodes of VT requiring immediate therapy with medications or ablation
Untreated hypothyroidism or hyperthyroidism. Patients who are euthyroid on thyroid hormone replacement therapy are acceptable.
Current enrollment in another investigational drug or device study.
Presence of any other condition that the investigator feels would be problematic or would restrict or limit the participation of the patient for the entire study period.
Absolute contra-indication to the use of heparin and or warfarin.
Documented intra-atrial thrombus, ventricular thrombus (< 6 months after detection of thrombus), tumor, or another abnormality which precludes catheter introduction.
Females of childbearing potential who are not practicing protocol acceptable method of birth control.

Sites / Locations

Northwestern University
Mayo Clinic
Hospital of the University of Pennsylvania
Texas Cardiac Arrhythmia Research Foundation
University of Virginia Health System
Hamilton Health Sciences
Southlake Regional Health Centre
University of Ottawa Heart Institute
McGill University Health Center
Institut Universitaire de Cardiologie et Pneumologie de Québec
Beijng Fuwai Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Ablation

Amiodarone

Arm Description

Catheter based radiofrequency ablation for ischemic ventricular tachycardia

amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study.

Outcomes

Primary Outcome Measures

Number of Participants With Appropriate ICD Therapy, Slow VT or Sudden Cardiac Death

Number of participants with a composite outcome of any of: Appropriate Implantable Cardioverter Defibrillator (ICD) therapy [Including antitachycardia pacing (ATP) and shocks] Slow ventricular tachycardia (VT) below ICD detection threshold leading to hospitalization or necessitates antiarrhythmic medications and/or catheter ablation Sudden Cardiac Death

Secondary Outcome Measures

Number of Participants With (a) Ablation or Amiodarone Complications, (b) Inappropriate Shocks From ICD, or (c) Need for Concomitant Use of Sotalol, Dofetilide, Azimilide or Class 1 Antiarrhythmic Agents in Either Arm of the Trial.

Number of Participants with (a) Ablation or Amiodarone Complications, (b) Inappropriate Shocks from ICD, or (c) Need for Concomitant use of Sotalol, Dofetilide, Azimilide or Class 1 Antiarrhythmic agents in either arm of the trial.

Quality of Life Score

Quality of life score in each treatment arm using the EQ-5D Visual Analogue Scale (VAS) (euroqol.org). The EQ-5D VAS is a patient reported scale from 0 to 100 on which the patient rates how good or bad their health is today with 100 being the best health they can imagine and 0 being the worst health they can imagine.

Full Information

NCT ID

NCT01097330

First Posted

March 31, 2010

Last Updated

January 17, 2020

Sponsor

Population Health Research Institute

Collaborators

Abbott Medical Devices, Hamilton Health Sciences Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01097330

Brief Title

Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia

Acronym

CEASE-VT

Official Title

Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia: A Multi-center Randomized Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Terminated

Why Stopped

Anticipated non-feasibility of recruitment objectives

Study Start Date

August 2010 (Actual)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Population Health Research Institute

Collaborators

Abbott Medical Devices, Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Implantable Cardioverter Defibrillators (ICDs) provide a shock or pacing therapy to bring back a normal heart beat when a patient experiences a dangerous abnormal heart rhythm such as ventricular tachycardia (VT). ICDs are very successful in bringing back a normal heart beat when VT occurs, but they do not prevent further dangerous heart rhythms from occurring. This study is designed to determine the best way to manage patients who have an ICD and who continue to have episodes of VT. There are two methods for treatment the VT: 1) Ablation, and 2) Medication. An ablation procedure involves placing a flexible catheter (insulated wire) in the groin area and threading it into the heart. After the doctor has located the affected area responsible for the VT, radiofrequency energy is delivered by the power generator through the catheter to the inside of the heart. The radiofrequency energy ablates (burns) a small area of the heart tissue thought to cause the VT. A medication called Amiodarone is an "anti-arrhythmic" prescribed to prevent abnormal heart rhythms from recurring. The purpose of this study is to compare these two different methods for treating VT. Treatment with ablation and amiodarone are both considered the standard of care for patients with VT but they have not been compared directly in a study like this before.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Defibrillators, Implantable, Tachycardia, Ventricular

Keywords

Defibrillators, Implantable, Tachycardia, Ventricular, Catheter Ablation, Amiodarone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ablation

Arm Type

Active Comparator

Arm Description

Catheter based radiofrequency ablation for ischemic ventricular tachycardia

Arm Title

Amiodarone

Arm Type

Active Comparator

Arm Description

amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study.

Intervention Type

Procedure

Intervention Name(s)

Ablation

Other Intervention Name(s)

VT ablation, ischemic VT ablation, catheter ablation, radiofrequency ablation

Intervention Description

Catheter based radiofrequency ablation for ischemic ventricular tachycardia scheduled to occur within 4 weeks after randomization

Intervention Type

Drug

Intervention Name(s)

Amiodarone

Other Intervention Name(s)

Cordarone

Intervention Description

Amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study

Primary Outcome Measure Information:

Title

Number of Participants With Appropriate ICD Therapy, Slow VT or Sudden Cardiac Death

Description

Time Frame

From 30 days following randomization until final follow-up visit

Secondary Outcome Measure Information:

Title

Description

Time Frame

from randomization until final follow-up

Title

Quality of Life Score

Description

Time Frame

At 6 months follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

84 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria - Patients must meet all of the following criteria: > 18 and < 85 years of age ICD implanted for primary prophylaxis against sudden cardiac death or ICD implanted for secondary prophylaxis against spontaneous or inducible sustained VT without any reversible causes Coronary artery disease (CAD) with prior myocardial infarction (MI) ICD or electrocardiogram (ECG) documentation of ventricular arrhythmia responsible for appropriate ICD therapy [antitachycardia pacing (ATP) & shocks]. Exclusion Criteria - Patients should not have any of the following criteria: Contraindication or allergy to contrast media, routine procedural medications or catheter materials Contraindication to an interventional procedure Current or previous (within 3 months) amiodarone therapy Atrial Fibrillation requiring antiarrhythmic drug therapy Contraindication to amiodarone therapy New York Heart Association (NYHA) functional class IV Myocardial infarction within the past 60 days Stroke within the past 90 days Unstable angina Hypertrophic cardiomyopathy, Non-ischemic dilated cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Brugada Syndrome, Catecholamine sensitive polymorphic VT or long QT syndrome Patients with active ischemia that are eligible for revascularization Life expectancy less than 6 months Incessant or multiple episodes of VT requiring immediate therapy with medications or ablation Untreated hypothyroidism or hyperthyroidism. Patients who are euthyroid on thyroid hormone replacement therapy are acceptable. Current enrollment in another investigational drug or device study. Presence of any other condition that the investigator feels would be problematic or would restrict or limit the participation of the patient for the entire study period. Absolute contra-indication to the use of heparin and or warfarin. Documented intra-atrial thrombus, ventricular thrombus (< 6 months after detection of thrombus), tumor, or another abnormality which precludes catheter introduction. Females of childbearing potential who are not practicing protocol acceptable method of birth control.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrea Natale, M.D.

Organizational Affiliation

Texas Cardiac Arrhythmia Research Foundation

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

David J Callans, M.D.

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Carlos A. Morillo, M.D.

Organizational Affiliation

Population Health Research Institute, McMaster University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Girish M. Nair, M.D.

Organizational Affiliation

Population Health Research Institute, McMaster University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Hospital of the University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Texas Cardiac Arrhythmia Research Foundation

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

University of Virginia Health System

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Facility Name

Hamilton Health Sciences

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 2X2

Country

Canada

Facility Name

Southlake Regional Health Centre

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y 2P9

Country

Canada

Facility Name

University of Ottawa Heart Institute

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Y 4W7

Country

Canada

Facility Name

McGill University Health Center

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1A4

Country

Canada

Facility Name

Institut Universitaire de Cardiologie et Pneumologie de Québec

City

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

Facility Name

Beijng Fuwai Heart Hospital

City

Beijing

ZIP/Postal Code

100037

Country

China

12. IPD Sharing Statement

Links:

URL

http://www.phri.ca/

Description

Population Health Research Institute

Learn more about this trial

Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia

We'll reach out to this number within 24 hrs