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Bipolar Ventricular Tachycardia (VT) Study

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ClinicalTrials.gov Identifier: NCT02374476
Recruitment Status : Suspended (DMC recommended enrollment halt due to a higher proportion anticipated SAEs in intervention group vs registry group.)
First Posted : February 27, 2015
Last Update Posted : March 19, 2019
Sponsor:
Collaborator:
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

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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02374476


Locations
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United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Massachusetts
Brigham & Womans Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States, 78705
Sponsors and Collaborators
Srinivas Dukkipati
Biosense Webster, Inc.
Investigators
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Principal Investigator: Srinivas Dukkipati, MD Icahn School of Medicine at Mount Sinai

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Responsible Party: Srinivas Dukkipati, Co-Director EP Service, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02374476     History of Changes
Other Study ID Numbers: GCO 14-1827
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
VT
Refractory VT
VT Storm
Ventricular Fibrillation
V Fib
VF
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes