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Clinical Trials/NCT04694079
NCT04694079CompletedPhase 4

VOYAGE- Ventricular Tachycardia Ablation and Myocardial Scar Characterization With Magnetic Resonance

Azienda Ospedaliero, Universitaria Pisana7 sites in 1 country104 target enrollmentStarted: August 3, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
104
Locations
7
Primary Endpoint
VT recurrences

Study Overview

Brief Summary

Previous monocentric experiences have already highlighted the role of preoperative cardiac imaging, in particular of cardiac magnetic resonance (CMR) and tomography (CT), in improving the ablation results of scar-related ventricular tachycardia (VT). A better characterization of scar obtained with high quality CMR images and post processing data with creation of maps exploring the heart in concentric layers from the endocardium to the epicardium could allow a personalized and more precise approach to this pathology.

Aim of the study - Evaluating the feasibility and possible benefit of CMR-guided ablative approach (group 1: ablation of the "anatomical" channels of heterogeneous tissue within the scar) compared to CMR-aided approach (group 2: ablation of the "electrical" conduction channels within the scar) and standard approach (group 3: ablation guided by an electro-anatomical system without the aid of CMR) in a multi-center Tuscan study.

What would add the project to what is known - The achievement of the objectives by the project would allow to propose a personalized ablation on the basis of the scar characterization and would allow a better efficacy, efficiency of the procedure and probably also a safer treatment

Detailed Description

State of the art and preliminary data

Patients with structural heart disease (SHD) are at increased risk of VAs that can promote life-threatening events, for whom a proper treatment has a pivotal role. The use of antiarrhythmic drugs is limited due to their ineffectiveness in reducing related mortality or their common side effects. Implantable cardioverter defibrillator (ICD) can improve survival in a certain group of patients with SHD, but recurrent ventricular tachycardia (VT) needing ICD shocks reduce quality of life and probably patients survival. Moreover, ICD implant is affected by a noticeable risk of acute and chronic complications, that can reduce the survival of ICD recipient. Catheter ablation is an effective technique especially for the management of post-myocardial infarction ventricular tachycardia (post-myocardial infarction VT) and the recent VANISH trial showed that ablation reduced the composite primary outcome of death, VT storm or appropriate ICD shocks compared to patients with an escalation of amiodarone.

The introduction of a catheter in the ventricular chambers through a vascular access, allows to map the VT circuit that is usually inside the scar, and perform an ablation of the tissue responsible of the VAs substrate. The signals recorded by the catheter and the fluoroscopy images have been used to localize the target since 90s, but in the last decade the emergence of technological innovations, such as three-dimensional electroanatomic mapping (3D-EAM), has enhanced our ability to identify ablation targets. Three-dimensional electroanatomic mapping enables to generate a 3D reconstruction of any part of the heart without needing fluoroscopic navigation. Integration between anatomic and electrocardiographic (ECG) data it is very useful in choosing an optimal location for VA ablation, and the use of mapping systems contributed to reduce procedural, fluoroscopy and radiofrequency time. However, the efficacy of 3D-EAM can be suboptimal when we decide to follow a strategy of substrate ablation. Substrate ablation is characterized by an ablation of abnormal electrograms (EGMs) identified during sinus rhythm or ventricular pacing. In a recent meta-analysis, the combined risk of ventricular arrhythmia recurrence and all-cause mortality during long-term follow-up was lower when using a substrate-based approach compared to standard ablation of stable VT. However, efficacy was greatly reduced if the homogenization of the arrhythmic substrate was incomplete.

Real-time integration of anatomical VT substrate from data coming from cardiac image such as cardiac magnetic resonance (CMR) and multidetector computed tomography (CT) with EAM seems to improve efficacy of VA radiofrequency ablations and use of scar integration from imaging was an independent predictors of VT-free survival after catheter ablation in post-MI VT in recent papers. However, integration of CMR and CT images in the EAM system hasn't allowed to avoid, until now, an EAM that is time consuming, often imprecise and allowing only an incomplete substrate modification. Based on this consideration, we thought that an image integration taking into account not only the location of scar, but also its quantification and characterization could increase the efficiency of the ablation procedure, with an improvement of acute and chronic outcome. For this purpose, CMR has a pivotal role, allowing at characterizing the scar tissue via color-coded pixel signal intensity (PSI) maps that have a high correlation with the electroanatomic maps obtained during the ablation procedures. Particularly, the VT isthmuses found with the EAM correlated with the presence of heterogeneous tissue channels (HTCs) depicted in the PSI maps. Previous experiences demonstrated that these PSI maps can be imported in the navigation system to help substrate ablation, but only if they are obtained from high spatial resolution late gadolinium enhancement (LGE)-CMR images. One recent publication showed that CMR-aided scar dechanneling was associated with a lower need for ablation delivery, higher non-inducibility rates after substrate ablation, and reduced VT recurrences in the follow-up. In brief, in this experience the target ablation sites were the conducting channels (CC) entrances (i.e. entrances of VT isthmuses) identified in the substrate EAM, but PSI maps integrated into the navigation system were used to focus on specific regions of the scar. The authors found 23% of false negative (CCs evidence outside the HTCs entrances) and 16% of false positives (HTCs only identified in PSI maps). The HTCs identified only in the PSI maps, without matching with a CC on the EAM, were not targeted for ablation. Very recently, the same group presented results about a possible improvement of the outcome (particularly the efficiency, but probably with extension to efficacy and safety) using a CMR guided ablation, targeting only the HCTs (all of them). However, both experiences with CMR aided and guided ablation had been performed with a retrospective design and in a single-centre high volume laboratory, and for this reason we don't know the potential application of this technique in the real world of clinical electrophysiology.

The investigators sought to evaluate the feasibility, efficacy, safety and efficiency of a VT ablation guided or aided by CMR in comparison with VT ablation guided only by EAM (standard approach nowadays).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Indication for VT ablation in patients with SHD (indications according to the 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death);
  • Structural heart disease (clinical history, EKG, multimodality imaging)
  • Signed informed consent;

Exclusion Criteria

  • Age <18 y;
  • ICD not already implanted nor expected within 1 month;
  • High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons);
  • Inability to give written informed consent;
  • Pregnancy (suspected or confirmed);
  • Acute coronary syndrome in the previous 3 months;
  • Creatinine clearance < 15 ml/min (stage 5 CKD) (according to clinical history or out/in-patient tests performed upon enrollment)
  • Severe chronic liver disease (Child-Pugh score C) (according to clinical history or out/in-patient tests performed upon enrollment)
  • Heart surgery for valve disease in the previous 6 months or expected within 6 months,
  • NYHA functional class IV heart failure or CCS functional class IV angina
  • Previous VT ablation (redo procedure).
  • Systemic illness likely to limit survival to < 1 year

Arms & Interventions

Group 1, CMR-guided VT ablation

Experimental

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.

Intervention: Group 1, CMR-guided/aided VT ablation (Procedure)

Group 2, CMR-aided VT ablation

Experimental

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.

Intervention: Group 2, CMR-aided VT ablation (Procedure)

Group 3, Electroanatomical guided ablation

Active Comparator

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.

Intervention: Group 3, Electroanatomical guided ablation (Procedure)

Outcomes

Primary Outcomes

VT recurrences

Time Frame: 12-month

To compare the recurrences of the CMR guided/aided approaches in comparison to control group

Secondary Outcomes

  • VT non-inducibility(1 month)
  • CMR images suitability(1 month)
  • Efficiency(1 month)
  • Number of participants with Complications(12-month)
  • Rate of ICD interventions(12-month)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Giulio Zucchelli

Principal investigator

Azienda Ospedaliero, Universitaria Pisana

Study Sites (7)

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