Bipolar Ventricular Tachycardia (VT) Study (NCT02374476) | Clinical Trial Compass
CompletedNot Applicable
Bipolar Ventricular Tachycardia (VT) Study
United States145 participantsStarted 2015-02-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Achieving Freedom From Recurrent Ventricular Tachycardia (VT)