Recurrent Ventricular Tachycardia, Sustained Monomorphic VT (MMVT)
Conditions
Keywords
Ventricular Tachycardia, Isochronal Late Activation Mapping, high-density mapping, deceleration zone
Brief summary
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.
Interventions
DEVICEIsochronal Late Activation Mapping (ILAM)
an 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)
DEVICEHigh Density Voltage Mapping
high-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).
Sponsors
University of Arizona
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
randomized controlled clinical trial with 1:1 randomization to two strategies for ventricular tachycardia (VT) mapping and ablation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Criteria To participate in this clinical investigation, the subjects must meet all of the following inclusion criteria: 1. Patient is ≥18 years of age. 2. Able and willing to comply with all study requirements. 3. 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. 4. 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. 5. Refractory (i.e., not effective, not tolerated, or not desired) to at least one anti-arrhythmic medication (including, but not limited to beta blocker, mexiletine, amiodarone or sotalol) for treatment of MMVT. 6. Structural heart disease (ischemic or non-ischemic) with one of the following (a, b or c): 1. Evidence of myocardial scar by echocardiography (segmental wall motion or wall thinning), CT (wall thinning) and/or MRI (presence of delayed enhancement /late gadolinium enhancement) . CT or MRI with scar is mandatory for inclusion of NICM., or 2. Left ventricular ejection fraction (EF) \<50% \[documented within the last 6 months via transthoracic echocardiogram (TTE), MRI\] with presence of scar, or 3. Arrhythmogenic RV cardiomyopathy/dysplasia (per 2010 ARVC/D Task Force Criteria)
Exclusion criteria
Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inducibility for VT | after initial 25 minutes of ablation (minutes of radiofrequency) | Inducibility for VT after initial 25 minutes of ablation (minutes of radiofrequency) |
| Recurrent VT | 1 year post procedure | recurrent VT at 1 year |
| CV Hospitalization | 1 year post procedure | Hospitalization due to Cardiovascular complications related to heart failure or arrhythmia at 1 year |
| Mortality | 1 year post procedure | Mortality at 1 year |
| Procedure Related Safety | Duration of Hospitalization (up to 7 days) | hematoma requiring transfusion, cardiac perforation, stroke, hemorrhage, pericardial effusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Individual assessment of four endpoints comprising the primary endpoint. | 1 year post procedure | Individual assessment of four individual endpoints comprising the primary endpoint. |
| Total radiofrequency time delivered and procedural time. | Duration of Procedure | — |
| Reduction in VT burden | 1 year post procedure | — |
| Quality of Life improvement | 1 year post procedure | 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. |
| Procedural complications | Duration of Hospitalization (up to 7 days) | tamponade, hematoma requiring transfusion, stroke, emergent surgery |
| Length of stay in hospital from index procedure | Duration of Hospitalization (up to 7 days) | — |
| Rate of Acute Kidney Injury | 1 day post procedure | Number of Participants with acute kidney injury, verified by creatinine checked the day after ablation. |
Countries
United States
Contacts
CONTACTPriyanka Sharma
CONTACTDalise Shatz
PRINCIPAL_INVESTIGATORRoderick Tung, MD
University of Arizona
Outcome results
None listed