Functional ElectroAnatomiC Isochronal Late Activation Mapping for Empiric VT Ablation Trial

Обзор

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.

Вмешательства

• Устройство Isochronal 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)
• Устройство High 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).

Первичные конечные точки

• Inducibility for VT [Срок оценки: after initial 25 minutes of ablation (minutes of radiofrequency)]
• Recurrent VT [Срок оценки: 1 year post procedure]
• CV Hospitalization [Срок оценки: 1 year post procedure]
• Mortality [Срок оценки: 1 year post procedure]
• Procedure Related Safety [Срок оценки: Duration of Hospitalization (up to 7 days)]

Вторичные конечные точки (7)

• Individual assessment of four endpoints comprising the primary endpoint. [Срок оценки: 1 year post procedure]
• Total radiofrequency time delivered and procedural time. [Срок оценки: Duration of Procedure]
• Reduction in VT burden [Срок оценки: 1 year post procedure]
• Quality of Life improvement [Срок оценки: 1 year post procedure]
• Procedural complications [Срок оценки: Duration of Hospitalization (up to 7 days)]
• Length of stay in hospital from index procedure [Срок оценки: Duration of Hospitalization (up to 7 days)]
• Rate of Acute Kidney Injury [Срок оценки: 1 day post procedure]

Критерии участия

Criteria

To participate in this clinical investigation, the subjects must meet all of the following inclusion criteria:

• 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.
• 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.
• Structural heart disease (ischemic or non-ischemic) with one of the following (a, b or c):

• 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
• Left ventricular ejection fraction (EF) <50% \[documented within the last 6 months via transthoracic echocardiogram (TTE), MRI\] with presence of scar, or
• Arrhythmogenic RV cardiomyopathy/dysplasia (per 2010 ARVC/D Task Force Criteria)

Критерии исключения

Subjects who meet any of the following exclusion criteria must be excluded from the clinical investigation:

• 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).
• Currently receiving support via extracorporeal membrane oxygenation (ECMO) or ventricular assist device (VAD).
• Left Ventriclar ejection fraction < 15%.
• Stroke within 30 days or presence of LV thrombus within 1 month prior to enrollment.
• Idiopathic VT or preprocedural imaging without scar (MRI or CT).
• Limited life expectancy of 1 year or less.
• Presence of mitral and aortic valves both mechanical.
• Ventricular tachycardia secondary to electrolyte imbalance or any other reversible or non-cardiac cause.
• Severe aortic stenosis or flail mitral valve with severed mitral regurgitation.
• Thrombocytopenia (defined as platelet count <50,000/μl ) or coagulopathy.
• Ventricular arrhythmias secondary to underlying channelopathies (LQTS, Brugada Syndrome).
• Enrolled in an investigational study evaluating another device or drug that would confound the results of this study.
• Other anatomic or co-morbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow up requirement of 1 year, or impact the scientific integrity of the study results.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Banner University Medical Center Phoenix — Phoenix

Публикации

• Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL. 2013 ACCF/AHA guideline for the management of heart failure: executive summary: a report of the American College of Cardiology Found PMID 23741057
• Seiler J, Roberts-Thomson KC, Raymond JM, Vest J, Delacretaz E, Stevenson WG. Steam pops during irrigated radiofrequency ablation: feasibility of impedance monitoring for prevention. Heart Rhythm. 2008 Oct;5(10):1411-6. doi: 10.1016/j.hrthm.2008.07.011. Epub 2008 Jul 10. PMID 18929327
• Jais P, Maury P, Khairy P, Sacher F, Nault I, Komatsu Y, Hocini M, Forclaz A, Jadidi AS, Weerasooryia R, Shah A, Derval N, Cochet H, Knecht S, Miyazaki S, Linton N, Rivard L, Wright M, Wilton SB, Scherr D, Pascale P, Roten L, Pederson M, Bordachar P, Laurent F, Kim SJ, Ritter P, Clementy J, Haissaguerre M. Elimination of local abnormal ventricular activities: a new end point for substrate modifica PMID 22492578
• Jiang R, Beaser AD, Aziz Z, Upadhyay GA, Nayak HM, Tung R. High-Density Grid Catheter for Detailed Mapping of Sinus Rhythm and Scar-Related Ventricular Tachycardia: Comparison With a Linear Duodecapolar Catheter. JACC Clin Electrophysiol. 2020 Mar;6(3):311-323. doi: 10.1016/j.jacep.2019.11.007. Epub 2020 Jan 29. PMID 32192682
• Raiman M, Tung R. Automated isochronal late activation mapping to identify deceleration zones: Rationale and methodology of a practical electroanatomic mapping approach for ventricular tachycardia ablation. Comput Biol Med. 2018 Nov 1;102:336-340. doi: 10.1016/j.compbiomed.2018.07.012. Epub 2018 Jul 18. PMID 30033360
• Marcus FI, McKenna WJ, Sherrill D, Basso C, Bauce B, Bluemke DA, Calkins H, Corrado D, Cox MG, Daubert JP, Fontaine G, Gear K, Hauer R, Nava A, Picard MH, Protonotarios N, Saffitz JE, Sanborn DM, Steinberg JS, Tandri H, Thiene G, Towbin JA, Tsatsopoulou A, Wichter T, Zareba W. Diagnosis of arrhythmogenic right ventricular cardiomyopathy/dysplasia: proposed modification of the task force criteria. PMID 20172911
• Irie T, Yu R, Bradfield JS, Vaseghi M, Buch EF, Ajijola O, Macias C, Fujimura O, Mandapati R, Boyle NG, Shivkumar K, Tung R. Relationship between sinus rhythm late activation zones and critical sites for scar-related ventricular tachycardia: systematic analysis of isochronal late activation mapping. Circ Arrhythm Electrophysiol. 2015 Apr;8(2):390-9. doi: 10.1161/CIRCEP.114.002637. Epub 2015 Mar 4. PMID 25740836
• Tung R, Josephson ME, Bradfield JS, Shivkumar K. Directional Influences of Ventricular Activation on Myocardial Scar Characterization: Voltage Mapping With Multiple Wavefronts During Ventricular Tachycardia Ablation. Circ Arrhythm Electrophysiol. 2016 Aug;9(8):e004155. doi: 10.1161/CIRCEP.116.004155. PMID 27516464

Идентификаторы

NCT: NCT06931821 · STUDY00003834

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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