Bipolar Ventricular Tachycardia (VT) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02374476
Recruitment Status : Recruiting
First Posted : February 27, 2015
Last Update Posted : March 21, 2018
Biosense Webster, Inc.
Information provided by (Responsible Party):
Srinivas Dukkipati, Icahn School of Medicine at Mount Sinai

Brief Summary:
This non-randomized study will examine the safety and efficacy of irrigated bipolar radiofrequency (RF) ablation in the treatment of ventricular tachycardia (VT) in patients for whom standard VT unipolar RF ablation has been unsuccessful. VT is a serious abnormality of the heart's electrical system. Ablation is a procedure that cauterizes heart tissue using catheters (long tubes that can be moved within or along the outside of the heart). Cauterizing the heart tissue is accomplished by using heat to damage the abnormal heart tissue that is not working well so that it can stop affecting the rest of the heart. Usually, heat is delivered using a unipolar catheter, in which energy travels from the catheter tip to a grounding pad. This research study seeks to find out if a bipolar ablation catheter, in which the energy travels between two catheter tips on either side of the heart muscle, can be used to eliminate the arrhythmia when the unipolar ablation is unsuccessful. The hypothesis is that the increased current density and improved rates of transmural lesion creation seen with bipolar RF ablation will lead to successful arrhythmia termination with minimal or no increased risk of complication.

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Device: Bipolar Ablation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bipolar Catheter Ablation for the Treatment of Refractory Scar-Related Ventricular Arrhythmia
Actual Study Start Date : February 18, 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Bipolar Ablation
All patients who meet inclusion criteria and have VT not terminable with unipolar ablation will undergo bipolar ablation.
Device: Bipolar Ablation
Patients will undergo bipolar ablation if unipolar ablation unsuccessful

Primary Outcome Measures :
  1. Freedom from recurrent VT [ Time Frame: 6 months ]
    Freedom from recurrent VT at 6 months, defined as sustained ventricular tachycardia lasting longer than 30 seconds and identified due to clinical symptoms or during device interrogation.

Secondary Outcome Measures :
  1. Procedural complications [ Time Frame: 6 months ]
    Incidence of procedural complications which includes death, stroke, MI, heart failure, conduction abnormalities, pericardial effusion requiring drainage, hematoma, pseudoaneurysm

  2. Post-ablation inducibility [ Time Frame: 6 months ]
    Incidence of the induction of any sustained arrhythmia post-ablation, with a duration > 15 seconds of MMVT. Post ablation inducibility is measured via program stimulation.

  3. Time to termination [ Time Frame: 6 months ]
  4. Total duration of bipolar ablation [ Time Frame: 6 months ]
  5. All cause mortality [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ≥ 18 years of age.
  • The study will include all forms of scar VT--both ischemic (post-myocardial infarction) and non-ischemic (eg sarcoid, amyloid, dilated)--as determined by cardiac MRI and/or voltage mapping at the time of VT ablation.
  • Intramural VT not terminable with unipolar ablation once enrolled in the Bipolar study or previous failed unipolar ablation within 6 months prior to enrollment.
  • Ability to understand the requirements of the study and sign the informed consent form.
  • Willingness to adhere to study restrictions and comply with all post- procedural follow-up requirements
  • Projected lifespan greater than 1 year.

Exclusion Criteria:

  • Tissue Thickness less than 5 mm as assessed by electroanatomic mapping, CT, or MRI.
  • MI or CABG within 6 weeks.
  • NYHA Class IV CHF.
  • Women known to be pregnant or to have positive beta-HCG.
  • Participation in another study that would interfere with this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02374476

Contact: Betsy A Ellsworth, MSN 212-824-8902
Contact: Stephanie Harcum, BA 212-824-8927

United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Jean Del Priore, RN    708-216-2644   
Principal Investigator: David Wilber, MD         
United States, Massachusetts
Brigham & Womans Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Christine Pelligrini, MSN, MHSA    617-732-5241   
Principal Investigator: Usha Tedrow, MD         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jen Kaufman    617-632-8956   
Principal Investigator: Elad Anter, MD         
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Betsy Ellsworth, MSN    212-824-8902   
Contact: Stephanie Harcum, BA    212-824-8927   
Principal Investigator: Srinivas Dukkipati, MD         
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mary Gnap    215-615-0781   
Principal Investigator: Pasquale Santangeli, MD         
United States, Texas
Texas Cardiac Arrhythmia Research Foundation Recruiting
Austin, Texas, United States, 78705
Contact: Deb Cardinal    512-458-9410   
Principal Investigator: Andrea Natale, MD         
Sponsors and Collaborators
Srinivas Dukkipati
Biosense Webster, Inc.
Principal Investigator: Srinivas Dukkipati, MD Icahn School of Medicine at Mount Sinai

Responsible Party: Srinivas Dukkipati, Co-Director EP Service, Icahn School of Medicine at Mount Sinai Identifier: NCT02374476     History of Changes
Other Study ID Numbers: GCO 14-1827
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Srinivas Dukkipati, Icahn School of Medicine at Mount Sinai:
Refractory VT
VT Storm
Ventricular Fibrillation
V Fib

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