Ablation-Index Guided Scar-Mediated Ventricular Tachycardia Ablation in Patients With Ischemic Cardiomyopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRush University Medical Center
About this trial
Over the last decade, radiofrequency catheter ablation (RFCA) has become an established treatment for ventricular arrhythmias (VA). Due to the challenging nature of visualizing lesion formation in real time and ensuring an effective transmural lesion, different surrogate measures of lesion quality have been used. The Ablation Index (AI) is a variable incorporating power delivery in its formula and combining it with CF and time in a weighted equation which aims at allowing for a more precise estimation of lesion depth and quality when ablating VAs. AI guidance has previously been shown to improve outcomes in atrial and ventricular ablation in patients with premature ventricular complexes (PVC). However research on outcomes following AI-guidance for VT ablation specifically in patients with structural disease and prior myocardial infarction remains sparse. The investigators aim at conducting the first randomized controlled trial testing for the superiority of an AI-guided approach regarding procedural duration.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient ≥ 18 y.o.
Structural Heart Disease: Ischemic Cardiomyopathy
Sustained Scar-related Monomorphic Ventricular Tachycardia documented by ECG or CIED interrogation
Disqualifiers
If clinical ventricular arrhythmia is predominantly PVCs, supraventricular tachycardia, or ventricular fibrillation
Myocardial infarction or cardiac surgery within 6 months
Severe mitral regurgitation
Stroke or TIA within 6 months
Trial design
Design model
Parallel
Treatments tested in this trial
Ablation-index guided ventricular tachycardia ablation
Procedure/SurgeryAs described in arms descriptions
Ventricular tachycardia ablation with no AI-guidance
Procedure/SurgeryAs described in arms descriptions
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: AI-guided ablationExperimental treatment 1 intervention
Group B: non-AI guided ablationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage reduction in ablation time between the groups with/without AI guidance
Percentage of reduction in ablation time in seconds, with ablation time defined as the total radiofrequency delivery time delivered during the VT ablation procedure. Total ablation time is automatically recorded by the Carto System Software and will be subsequently extracted as part of a raw unedited data file for unbiased endpoint evaluation.
Time frame
intra-proceduralSecondary outcomes
1
Percentage of reduction in total procedural duration in seconds between the AI/not AI group
the time elapsed from injection of lidocaine as the start and removal of all catheters from the heart as the end of the procedure. Timestamps logged for these events in the EP lab will be used for unbiased endpoint evaluation.
Time frame
intra-procedural2
Total intravenous fluids administered in milliliters (ml)
Defined as total intravenous fluid volume administered in the EP laboratory
Time frame
intra-procedural3
Fluoroscopy duration in minutes
The time elapsed of procedural fluoroscopy usage in minutes
Time frame
intra-proceduralOther outcomes
1
Acute procedural success (no inducible VT), partial success (only non-clinical VT induced), and inducibility not tested at end of procedure (in number, % and risk-difference)
The acute procedural success will be defined as the absence of inducible ventricular tachycardia upon completion of the procedure, during further electrophysiologic testing in the EP laboratory. Partial success will be defined by the presence of residual non-clinical VTs, meaning inducible VTs which are not morphologically corresponding to the ones causing the patient's symptoms. Patients for whom the inducibility was not tested at the end of the procedure will be classified in a third category. The number of patients in each of the three categories and the proportion of each category, in percentage, to the whole cohort, will be assessed.
Time frame
intra-procedural2
Average ablation time per lesion (in seconds and percentage difference)
The ablation time for each patient will be indexed by the number of lesions applied to the myocardium. This ablation/time per lesion will be averaged over all patients using the correct summary measure depending on data distribution (normal or non-normal distributed data) and will be compared between arms.
Time frame
intra-procedural3
Number of RF lesions per patient (number, mean with standard deviation/median with interquartile range and percentage difference)
The number of radiofrequency application per patient during the ablation will be averaged over all patients using the correct summary measure depending on data distribution (normal or non-normal distributed data) and will be compared between arms.
Time frame
intra-procedural4
Ablation Index per lesion (absolute value and percentage difference)
The value of the ablation index for each lesion will be summarized in each arm, for the overall patient collective in that arm, using the correct summary measure depending on data distribution (normal or non-normal distributed data) and will be compared between arms.
Time frame
intra-proceduralSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rush University Medical Center
Lead sponsor
University of Michigan
Collaborator
Medical University of South Carolina
Collaborator
Biosense Webster, Inc.
Collaborator
Mayo Clinic
Collaborator
Brigham and Women's Hospital
Collaborator
Source ClinicalTrials.gov