Targeted Ablation to Isolate Scar Channels Causing Ventricular Tachycardia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNew York Medical College
About this trial
The goal of this study is to map conducting channels within scar that cause ventricular tachycardia (VT) in patients with scar in their hearts in order to block these channels from causing VT with targeted radiofrequency ablation (cautery).
Participants undergoing VT ablation mapping of these channels by pacing many sites within the scar area and determining where these channels exit the scar into normal tissue. These exits will be ablated. Immediate success and success at 1 year will be evaluated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with structural heart disease undergoing VT ablation
Disqualifiers
Unable or unwilling to sign consent
Cardiogenic shock or NYHA Class IV heart failure and not a candidate for mechanical circulatory support for the procedure (percutaneous left ventricular assist device (LVAD), extracorporeal membrane oxygenation, or implanted LVAD)
Absence of substrate during initial voltage mapping
Trial population
Patients presenting to Westchester medical Center for ablation of VT with structural heart disease
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Selective Substrate Isolation
Procedure/SurgeryAblation will be guided by mapping the substrate "from the inside out" by identifying conducting channels as they might be activated during VT. Extensive pace mapping will be performed within scar areas identified during sinus rhythm mapping. The course of these channels will be identified and ablated across the distal portion, just proximal to the exit based on shortest stimulus-to-QRS interval obtained.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Number of participants achieving substrate Isolation with ablation of exit sites
Inability to stimulate the ventricle (physiologic parameter) while pacing in the substrate area contained by the ablation lines through each pacemap exit, at sites that were able to stimulate the ventricle prior to ablation. This will be manifest by the absence of a QRS complex resultant from the pacing stimulus. This is a
Time frame
Perioperative/Periprocedural: This will be measured at the end of the study ablation procedure only.Secondary outcomes
1
VT invasive map exit and vMap exit match
Percent matching of VT exits determined by activation/entrainment/pace mapping for matched ECG morphologies with vMap determined exits
Time frame
Perioperative/Periprocedural: This will be measured throughout the study ablation procedure.2
Channel exit and vMap match
Percent matching of noninvasively mapped exit sites compared with invasively mapped channel exits
Time frame
Perioperative/Periprocedural: This will be measured throughout the study ablation procedure.3
Inducibility post initial ablation
VT inducibility after first lesion sets determined by channel mapping
Time frame
Perioperative/Periprocedural: This will be measured during the study ablation procedure, after the first set of radiofrequency lesions is placed based in initial mapping.4
1 year outcome
VT recurrence at 1 year determined by therapies delivered by implantable cardioverted defibrillator and presentation with sustained VT below ICD detection.
Time frame
1 year: This will be measured for each subject up to 1 year after the study procedure.Sponsors and contacts
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Source ClinicalTrials.gov