NCT02374476
Bipolar Ventricular Tachycardia (VT) Study
NA
COMPLETED
NCT02374476
INTERVENTIONAL
Bipolar Catheter Ablation for the Treatment of Refractory Scar-Related Ventricular Arrhythmia
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.
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.
Ventricular Tachycardia
- TREATMENT
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- Type: DEVICE
- Name: Bipolar Ablation
- Description: Patients will undergo bipolar ablation if unipolar ablation unsuccessful
- Arm Group Labels: Bipolar Ablation, Registry
- Srinivas Dukkipati