Functional ElectroAnatomiC Isochronal Late Activation Mapping for Empiric VT Ablation Trial
Trial statusNot yet recruiting
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
Qualifiers
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
Treatments tested in this trial
- Isochronal Late Activation Mapping (ILAM)
- High Density Voltage Mapping
Treatment groups
360 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Arizona
Lead sponsor
Abbott
Collaborator
Source ClinicalTrials.gov