Pilot Study of Catheter Ablation for Ventricular Tachycardia in Patients With an Implantable Cardioverter Defibrillator

NCT01576042 | Terminated Results DMC

• 2 other identifiers: Pro00033180Pro00036518
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this pilot trial is to determine the feasibility of a large, multi-center randomized clinical trial aimed to test whether a treatment strategy of percutaneous catheter ablation of ventricular tachycardia (VT) is superior to state-of-the-art pharmacologic therapy at reducing all-cause mortality in patients with an implantable cardioverter defibrillator (ICD) who receive therapy for VT in the absence of any reversible cause.

Conditions

Ventricular Tachycardia

Keywords

Ischemic heart disease; Implantable Cardioverter Defibrillator; Ventricular Tachycardia; Patient with Implantable Cardioverter Defibrillator (ICD)

Outcome Measures

Primary Outcomes (1)

• Number of Participants Completed Month 3 Follow-Up

  Records participants who completed Month 3 Follow-Up Visit

  3 months

Secondary Outcomes (7)

• Number of Participants Completed Month 6 Follow-Up

  6 Months

• Number of Participants Had at Least One of the Efficacy Outcome Measurement

  6 Months

• Cardiovascular Hospitalizations

  Baseline, 6 months

• Number of Participants Remained on Randomized Treatment Assignment

  6 month

• Number of Participants Switched to Other Arm

  6 months

Study Arms (2)

Catheter ablation

OTHER

The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults

Device: Biosense Webster's NAVI-STAR Thermo-Cool

Antiarrhythmic medication

OTHER

The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death

Drug: amiodarone; Drug: sotalol

Interventions

amiodarone DRUG

The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.

Also known as: Cordarone

Antiarrhythmic medication

sotalol DRUG

The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.

Also known as: Betapace, Betapace AF, Sotalex, Sotacor

Antiarrhythmic medication

Biosense Webster's NAVI-STAR Thermo-Cool DEVICE

The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults.

Catheter ablation

Eligibility Criteria

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

You may qualify if:

• Have an ICD with or without cardiac resynchronization therapy (i.e. CRT-D) for a primary or secondary prevention indication
• Have ischemic heart disease defined as the presence of wall motion abnormalities and documented coronary artery disease (one ≥ 70% stenosis in ≥ 1 major coronary artery)
• Have ≥ 1 documented ICD shock or ≥ 3 ATP therapies within 6 months before randomization for VT in the absence of a reversible cause that in the opinion of the treating physician requires further therapy. The VT has to be monomorphic and at a rate of ≤ 260 bpm.
• Be at least 18 years of age
• Be eligible for catheter ablation
• Have no history of intolerance or contraindication to at least 1 of the following antiarrhythmic medications: amiodarone, sotalol, and mexiletine.

You may not qualify if:

• Patients who in the opinion of the treating physician should not receive additional therapy
• More than 30 days of amiodarone treatment in the past 3 months unless the patient has been on ≤ 200 mgs of amiodarone daily for atrial arrhythmias or premature ventricular contractions (PVCs) and the patient is eligible for a higher dose of amiodarone
• Incessant VT that necessitates immediate treatment
• Reversible causes of VT including but not limited to ischemia, decompensated HF, and electrolyte disturbances
• The presence of a contraindication to catheter ablation of VT (including the presence of a mobile ventricular thrombus; an acute MI, coronary revascularization, or a stroke in the preceding 30 days; unstable angina or NYHA class IV HF; a mechanical valve; or inability to receive anticoagulation or antithrombotic therapy)
• Patients with non-ischemic cardiomyopathy
• Patients with hypertrophic obstructive, restrictive, or infiltrative cardiomyopathy
• Patients with acute myocarditis, congenital heart disease, valvular disease likely to require surgery in the next 1 year, and/or inoperable obstructive valvular disease
• Patients with a heart transplant or who are expected to undergo cardiac transplantation within 12 months
• Patients with a left ventricular assist device
• Patients who are already on antiarrhythmic drug therapy (other than beta-blockers) for VT (patients will not be excluded if they are receiving antiarrhythmic drug therapy for atrial arrhythmias or PVCs if they are eligible for additional drug therapy for VT).
• Heritable arrhythmias or increased risk for torsade de pointes with class III drugs
• End stage renal disease requiring dialysis
• Estimated life expectancy of \<1 year from a non-cardiac cause
• Women who are pregnant or who have childbearing potential and are not using a reliable method of contraception

Sponsors & Collaborators

• Duke University: lead
• Duke Clinical Research Institute: collaborator

Study Sites (5)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15237, United States

Location

Related Publications (36)

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MeSH Terms

Conditions

Tachycardia, Ventricular; Myocardial Ischemia

Interventions

Amiodarone; Sotalol

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Results Point of Contact

• Title: Sana M. Al-Khatib, MD, MHS
• Organization: Duke Clinical Research Institute

sana.alkhatib@dm.duke.edu

919-668-8649

Study Officials

• Sana M Al-Khatib, MD, MHS

  Duke University

  PRINCIPAL INVESTIGATOR

• William Stevenson, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 12, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: October 16, 2014
• Results First Posted: September 25, 2014

Record last verified: 2014-09

Locations

US (5)