Functional ElectroAnatomiC Isochronal Late Activation Mapping for Empiric VT Ablation Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Arizona
About this trial
This is a multicenter, prospective, parallel, randomized controlled trial to test for non-inferiority with an ILAM-guided VT ablation compared to conventional voltage- based ablation. The study has two treatment arms: conventional voltage mapping and ablation (control arm). In the investigational arm, the ablation strategy is guided by ILAM to target deceleration zones, blinded to voltage mapping. In the control arm, ablation will be performed to extensively ablate all low voltage regions (\<1.5mV) during sinus rhythm, right ventricular (RV) pacing, or left ventricular (LV) pacing, with discretionary use of pacemapping and activation mapping. In both arms, mapping with be performed with a multielectrode catheter (HD Grid) and ablation will be performed using an irrigated tip catheter (FlexAbility SE or Tactiflex catheters).
In the control armonly voltage mapping displays will be utilized (blinded to functional ILAM and fractionation). High density mapping with automated last deflection annotation (Ensite X) will be performed in all patients randomized to ILAM approach during either sinus rhythm or RV pacing.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient is ≥18 years of age.
Able and willing to comply with all study requirements.
At least one documented episode of sustained MMVT (>30 sec) by either EGM or ECG (including Holter, or loop recorder) in the 6 months prior to enrollment.
Informed of the nature of the study, agreed to its provisions, and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical study site.
Disqualifiers
Active infection (positive blood culture).
Patient is pregnant or nursing.
Cardiac surgery via sternotomy (CABG or valve repair/replacement) within 30 days prior to enrollment.
Contraindication to systemic anticoagulation (i.e., heparin, warfarin, or a direct thrombin inhibitor).
Trial design
Design model
Parallel
Treatments tested in this trial
Isochronal Late Activation Mapping (ILAM)
Devicean isochronal late activation mapping (ILAM) display with automated last deflection annotation (EnSite X™) will be used to identify regions of isochronal crowding around a line of conduction block for targeted ablation therapy using a standard irrigated tip catheter (Flexability SE \& Tactiflex catheters)
High Density Voltage Mapping
Devicehigh-density voltage mapping will serve as the method to display the electroanatomic substrate for extensive and diffuse ablation within the low voltage area (\<1.5 mV).
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: High Density Voltage MappingActive comparator 1 intervention
Group B: Isochronal Late Activation Mapping (ILAM)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Inducibility for VT
Inducibility for VT after initial 25 minutes of ablation (minutes of radiofrequency)
Time frame
after initial 25 minutes of ablation (minutes of radiofrequency)2
Recurrent VT
recurrent VT at 1 year
Time frame
1 year post procedure3
CV Hospitalization
Hospitalization due to Cardiovascular complications related to heart failure or arrhythmia at 1 year
Time frame
1 year post procedure4
Mortality
Mortality at 1 year
Time frame
1 year post procedureSecondary outcomes
1
Individual assessment of four endpoints comprising the primary endpoint.
Individual assessment of four individual endpoints comprising the primary endpoint.
Time frame
1 year post procedure2
Total radiofrequency time delivered and procedural time.
Time frame
Duration of Procedure3
Reduction in VT burden
Time frame
1 year post procedure4
Quality of Life improvement
The overall quality of life will be assessed using the SF-36 instrument, which includes 36 items rated on a 4-point Likert scale. In all nine subscales, lower scores indicate poorer outcomes in various areas, including physical functioning, social limitations due to physical or mental health issues, challenges related to work or daily activities, and feelings of nervousness, depression, fatigue, exhaustion, and pain.
Time frame
1 year post procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Arizona
Lead sponsor
Abbott
Collaborator
Source ClinicalTrials.gov