Bipolar Ventricular Tachycardia (VT) Study

NCT02374476 | Completed Results DMC FDA Device

• 1 other identifier: GCO 14-1827
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 6

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.

Conditions

Ventricular Tachycardia

Keywords

VT; Refractory VT; VT Storm; Ventricular Fibrillation; V Fib; VF

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving Freedom From Recurrent Ventricular Tachycardia (VT)

  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.

  6 months

Secondary Outcomes (5)

• Number of Procedural Complications

  6 months

• Number of Participants With Post-ablation Inducibility of VT

  6 months

• Time to Arrhythmia Termination for the Bipolar Group Only

  through termination, up to 60 seconds

• Total Duration of Bipolar Ablation

  average of 345 minutes

• Number of of Participants With Mortality

  6 months

Study Arms (2)

Bipolar Ablation

EXPERIMENTAL

All patients who meet inclusion criteria and have VT not terminable with unipolar ablation will undergo bipolar ablation.

Device: Bipolar Ablation

Registry

ACTIVE COMPARATOR

Participants in Patient Registry after standard radiofrequency (VT) unipolar radiofrequency (RF) ablation was successful

Device: Bipolar Ablation

Interventions

Bipolar Ablation DEVICE

Patients will undergo bipolar ablation if unipolar ablation unsuccessful

Bipolar Ablation; Registry

Eligibility Criteria

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

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Srinivas Dukkipati: lead
• Biosense Webster, Inc.: collaborator

Study Sites (6)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Brigham & Womans Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Srinivas R Dukkipati
• Organization: Icahn School of Medicine at Mount Sinai

srinivas.dukkipati@mountsinai.org

(212) 241-7114

Study Officials

• Srinivas Dukkipati, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Director EP Service

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: February 27, 2015
• Study Start: February 18, 2015
• Primary Completion: April 1, 2020
• Study Completion: September 30, 2020
• Last Updated: November 1, 2022
• Results First Posted: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)