Patients randomized to Group 1, will undergo CMR-guided VT ablation. LGE-CMR data obtained by 1,5 or 3 T CMR and multi-detector cardiac tomography (MDCT) data obtained using a 128 slice CT scanner will be processed with ADAS-VT software (Galgo Medical, Barcelona, Spain).

Ablation procedure will be carried out in an electrophysiology lab by using the CARTO 3 electroanatomical mapping system (Biosense Webster, Diamond Bar, CA, USA). A ThermoCool SmartTouch SF open irrigated 3,5 mm tip radiofrequency catheter (Biosense Webster, Diamond Bar, CA, USA) will be used both for mapping and ablation.

Ablation of the "anatomical" channels of heterogeneous tissue within the scar

Group 1, CMR-guided/aided VT ablation

Patients randomized to Group 2, will undergo CMR-aided VT ablation. LGE-CMR data obtained by 1,5 or 3 T CMR and multi-detector cardiac tomography (MDCT) data obtained using a 128 slice CT scanner will be processed with ADAS-VT software (Galgo Medical, Barcelona, Spain).

Ablation procedure will be carried out in an electrophysiology lab by using the CARTO 3 electroanatomical mapping system (Biosense Webster, Diamond Bar, CA, USA). A ThermoCool SmartTouch SF open irrigated 3,5 mm tip radiofrequency catheter (Biosense Webster, Diamond Bar, CA, USA) will be used both for mapping and ablation.

Ablation of the "electrical" conduction channels within the scar

Group 2, CMR-aided VT ablation

Patients assigned to Group 3, will not undergo LGE-CMR. Ablation procedure will be carried out in an electrophysiology lab by using the CARTO 3 electroanatomical mapping system (Biosense Webster, Diamond Bar, CA, USA). A ThermoCool SmartTouch SF open irrigated 3,5 mm tip radiofrequency catheter (Biosense Webster, Diamond Bar, CA, USA) will be used both for mapping and ablation.

Ablation guided by an electro-anatomical system without the aid of CMR

Group 3, Electroanatomical guided ablation

Azienda Ospedaliero, Universitaria Pisana

Use of AI guidance to conduct the ablation

Ablation-index guided ventricular tachycardia ablation

Ablation without AI guidance, AI values masked to the operator.

Ventricular tachycardia ablation with no AI-guidance

Henry D Huang, MD

Jorge E. Romero, MD

Obadah Aloum

Jorge Romero, MD

Jackson Liang, DO

Konstantinos Siontis, MD

Bishnu Dhakal, MD

Chandler Schwede

In this experimental arm, only functional substrate mapping will be used to guide ablation of conduction slowing regions, without VT induction or mapping during VT. Ablation targets of conduction slowing will be identified as: 1) deceleration zones of conduction slowing, previously defined as 3 isochrones coalescing within 1cm radius. 2) wavefront discontinuities represented by lines of conduction block, previously defined as late potentials with at least 20ms of isoelectric segment, and 3) regions of slow conduction characterized by high peak frequency (220-500Hz), which uses spectral frequency analysis to identify signals with highest frequency as a surrogate for slow conduction. All regions exhibiting any of these 3 surrogates of slow conduction will be ablated.

In this arm, invasive maps will be constructed by annotating the latest deflection and peak frequency during voltage mapping of stable intrinsic rhythm to localize areas of slow conduction. Annotated algorithms are cleared by the FDA. No VT will be purposefully induced in this experimental arm.

Functional Substrate-Only Mapping without VT Induction

Standard-of-care mapping, including voltage mapping of intrinsic rhythm, entrainment, activation, and/or pace mapping, will be performed to guide VT ablation. Standard VT induction protocols will be performed.

Conventional invasive scar (voltage) and electrical VT (entrainment, activation, pace) mapping will be used to guide VT ablation. Functional substrate mapping will not be used in this arm. VT will be induced using standard protocols.

Standard-of-Care Mapping/Imaging

Patients with ventricular tachycardia meeting class II-a/b indications in European guideline for catheter ablation, with a clinical VT event detected by an implanted ICD

Catheter ablation is a minimally invasive procedure. The physician advances multiple catheters into the heart that are used to diagnose and localize abnormal cardiac tissue involved in the initiation and maintenance of ventricular tachycardia and/or PVCs. Once the abnormal tissue is identified a specialized catheter is advanced to the target and energy is applied to destroy the abnormal tissue. The intervention will be identical to the conventional procedure except that an investigational ablation catheter will be used to deliver energy.

FieldForce™ Ablation System Ventricular Tachycardia

For VCAS-II group, patients with symptomatic frequent unifocal premature ventricular complexes (PVCs) meeting class II-a/b indications based on European guidelines for catheter ablation. For VCAS-II, documentation of frequent PVCs by 24 hours Holter with \>15% PVC burden for asymptomatic patients and \>5% PVC burden for symptomatic patients within the last 60 days.

FieldForce™ Ablation System Premature Ventricular Contractions

Catheter ablation procedure performed as part of standard care, although with the addition of an image-based 3D heart model including detailed anatomy and primary ablation targets

image-guided VT ablation strategy

Catheter ablation performed using conventional mapping techniques to identify targets. The ablation strategy will be left to the local investigator's decision, based on the clinical scenario and operator's habits.

Catheter ablation will be performed using conventional mapping techniques to identify targets. The ablation strategy will be left to the local investigator's decision, based on the clinical scenario and operator's habits.

conventional VT ablation strategy

LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

그룹 1: CMR 유도/보조 심실빈맥 절제술, 그룹 2: CMR 보조 심실빈맥 절제술, 그룹 3: 전기해부학적 유도 절제술

절제지수 유도 심실빈맥 절제술, AI 유도가 없는 심실빈맥 절제술

심실빈맥 유발 없이 기능적 기질만 매핑하는 표준 치료법 매핑/이미징

FieldForce™ 절제 시스템을 이용한 심실 빈맥, FieldForce™ 절제 시스템을 이용한 조기 심실 수축

영상 유도 심실빈맥 절제술 전략, 기존 심실빈맥 절제술 전략

브렌툭시맙 베도틴, 독소루비신 염산염, 빈블라스틴, 다카르바진, 삶의 질 평가, DNA 분석, RNA 분석, 플루오로데옥시글루코스 F 18, 양전자 방출 단층 촬영, 임상 생체 표지자 분석, 면역조직화학 염색법, 다형성 분석