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Clinical Trials/NCT02374476
NCT02374476CompletedNot Applicable

Bipolar Catheter Ablation for the Treatment of Refractory Scar-Related Ventricular Arrhythmia

Srinivas Dukkipati12 sites in 1 country145 target enrollmentStarted: February 18, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
145
Locations
12
Primary Endpoint
Number of Participants Achieving Freedom From Recurrent Ventricular Tachycardia (VT)

Study Overview

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.

Detailed Description

STUDY OBJECTIVE This study will examine the role of irrigated bipolar radiofrequency (RF) ablation for the treatment of intramural ventricular tachycardia in patients who have failed standard unipolar RF ablation. 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.

INTRODUCTION, RATIONALE Radiofrequency (RF) ablation is the most commonly employed method for the catheter treatment of cardiac arrhythmias. Myocardial scar serves as the most frequent substrate for the genesis of both atrial and ventricular arrhythmia. Such scar frequently contains surviving myocyte bundles interspersed with fibrotic tissue, which leads to slow conduction. Areas of denser fibrosis cause conduction block. When appropriately arranged, conduction through or around these scars leads to the creation of a "reentry" circuit through which an arrhythmia is generated and maintained. Each reentry circuit contains within it an area called the isthmus, a portion of the circuit located in a position intimately related to the scar border zone. Electrical activation travels slowly through the isthmus before breaking out into normal myocardium. Ablation at the site of an isthmus will terminate a reentrant tachycardia.

A variety of techniques, including electroanatomic mapping and activation, entrainment, and substrate mapping, are employed during electrophysiologic (EP) study to identify areas of myocardial scar and potential isthmus sites. Points or lines of ablation using RF energy are then created in an attempt to interrupt the reentry circuit. Typically, unipolar RF energy is applied via a catheter tip electrode to the endocardial or epicardial surface of the heart and grounded via an electrode pad placed on the patient's skin. RF energy in this setting is dispersed through the entirety of the tissue between catheter tip and grounding pad. The standard 7-French, 4-mm tip catheters are highly successful at ablating circuits located within a few millimeters of the catheter tip. A focal, 1mm area of resistive heating occurs within the myocardium immediately in contact with the catheter tip; myocardial cell death occurs several millimeters more deeply through passive, conductive heating, which spreads outward from the contact point.

While the standard catheter is effective at the ablation of superficial arrhythmias, it has proven more problematic when used for deep myocardial sites or for creating transmural lesions. A number of alternatives have been developed in an attempt to access these sites. 8-mm or 10-mm catheter tips are able to create larger zones of resistive heating, delivering direct RF energy to a larger area of myocardium. A larger interface between catheter tip and blood improves cooling and allows for the delivery of more power without a rise in impedence. The clinical use of these larger catheters can, however, be limited by rapid temperature rises at the catheter-tissue interface, resulting in thrombus formation, char, and "steam pop" rupture of the endocardial surface. The use of irrigated ablation catheters have improved upon the ability to deliver RF energy without a sustained rise in impedance. Both open irrigated- and closed-loop irrigated catheters circulate saline along the catheter tip-myocardial interface, allowing for continued delivery of RF current without thrombus formation at the endocardial surface. Intramyocardial temperature rises accordingly without a concomitant endocardial temperature surge, creating larger and deeper myocardial ablation zones. Catheters featuring a retractable needle tipped electrode with intramyocardial saline infusion have also shown promise as a means of accessing deep myocardial circuits in ventricular tachycardia ablation, but are not currently available in the US. Transcoronary ethanol ablation has also been employed with moderate success in patients with arrhythmias resistant to endocardial catheter ablation. This technology, however, grants only limited control over the size of the resulting infarct and is restricted by the need for perfusion of the scar zone by an accessible coronary artery.

Nevertheless, there remain occasions in which an arrhythmia cannot be eliminated by standard unipolar ablation technique. This is seen most frequently due to deep intramural ventricular tachycardia, sometimes encountered following myocardial infarction. Both standard and alternative ablation strategies are frequently either unavailable or inadequate for termination of these arrhythmias.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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.

Outcomes

Primary Outcomes

Number of Participants Achieving Freedom From Recurrent Ventricular Tachycardia (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 Outcomes

  • Total Duration of Bipolar Ablation(average of 345 minutes)
  • Number of of Participants With Mortality(6 months)
  • Time to Arrhythmia Termination for the Bipolar Group Only(through termination, up to 60 seconds)
  • Number of Procedural Complications(6 months)
  • Number of Participants With Post-ablation Inducibility of VT(6 months)

Investigators

Sponsor
Srinivas Dukkipati
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Srinivas Dukkipati

Co-Director EP Service

Icahn School of Medicine at Mount Sinai

Study Sites (12)

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