Ventricular Tachycardia Ablation and Myocardial Scar Characterization With Magnetic Resonance

NCT04694079 | Completed Phase 4

• 1 other identifier: 17288
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 7

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

Conditions

Myocardial Fibrosis; Ventricular Tachycardia

Keywords

Ventricular tachycardia; Cardiac magnetic resonance; Cardiac ablation

Outcome Measures

Primary Outcomes (1)

• VT recurrences

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

  12-month

Secondary Outcomes (5)

• Efficiency

  1 month

• VT non-inducibility

  1 month

• Number of participants with Complications

  12-month

• Rate of ICD interventions

  12-month

• CMR images suitability

  1 month

Study Arms (3)

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.

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

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.

Procedure: Group 2, CMR-aided VT ablation

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.

Procedure: Group 3, Electroanatomical guided ablation

Interventions

Group 1, CMR-guided/aided VT ablation PROCEDURE

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

Group 1, CMR-guided VT ablation

Group 2, CMR-aided VT ablation PROCEDURE

Ablation of the "electrical" conduction channels within the scar

Group 2, CMR-aided VT ablation

Group 3, Electroanatomical guided ablation PROCEDURE

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

Group 3, Electroanatomical guided ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead
• Azienda USL Toscana Nord Ovest: collaborator
• Azienda USL Toscana Sud Est: collaborator
• Azienda Ospedaliera Universitaria Senese: collaborator
• Fondazione Toscana Gabriele Monasterio: collaborator
• Centro Medico Teknon: collaborator

Study Sites (7)

Azienda USL Toscana Sud Est

Arezzo, AR, Italy

Location

Azienda USL Toscana Sud Est- U.O.C. Cardiologia, Ospedale Misericordia - Grosseto

Grosseto, GR, Italy

Location

Azienda USL Toscana Nord Ovest- U.O.C. Cardiologia, Ospedali Riuniti - Livorno

Livorno, LI, 57126, Italy

Location

Azienda USL Toscana Nord Ovest - U.O.C. Cardiologia, Ospedale Versilia

Camaiore, LU, Italy

Location

AOUPisana

Pisa, PI, 56100, Italy

Location

FTGM

Pisa, PI, 56100, Italy

Location

Azienda Ospedaliero Universitaria Senese - U.O.C. Cardiologia, Siena

Siena, SI, Italy

Location

Related Publications (11)

• Priori SG, Blomstrom-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J, Elliott PM, Fitzsimons D, Hatala R, Hindricks G, Kirchhof P, Kjeldsen K, Kuck KH, Hernandez-Madrid A, Nikolaou N, Norekval TM, Spaulding C, Van Veldhuisen DJ; ESC Scientific Document Group. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC). Eur Heart J. 2015 Nov 1;36(41):2793-2867. doi: 10.1093/eurheartj/ehv316. Epub 2015 Aug 29. No abstract available.

  PMID: 26320108 BACKGROUND

• Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002 Mar 21;346(12):877-83. doi: 10.1056/NEJMoa013474. Epub 2002 Mar 19.

  PMID: 11907286 BACKGROUND

• Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 Jan 20;352(3):225-37. doi: 10.1056/NEJMoa043399.

  PMID: 15659722 BACKGROUND

• Soto-Iglesias D, Acosta J, Penela D, Fernandez-Armenta J, Cabrera M, Martinez M, Vassanelli F, Alcaine A, Linhart M, Jauregui B, Efimova E, Perea RJ, Prat-Gonzalez S, Ortiz-Perez JT, Bosch X, Mont L, Camara O, Berruezo A. Image-based criteria to identify the presence of epicardial arrhythmogenic substrate in patients with transmural myocardial infarction. Heart Rhythm. 2018 Jun;15(6):814-821. doi: 10.1016/j.hrthm.2018.02.007. Epub 2018 Feb 7.

  PMID: 29427821 BACKGROUND

• Andreu D, Ortiz-Perez JT, Fernandez-Armenta J, Guiu E, Acosta J, Prat-Gonzalez S, De Caralt TM, Perea RJ, Garrido C, Mont L, Brugada J, Berruezo A. 3D delayed-enhanced magnetic resonance sequences improve conducting channel delineation prior to ventricular tachycardia ablation. Europace. 2015 Jun;17(6):938-45. doi: 10.1093/europace/euu310. Epub 2015 Jan 23.

  PMID: 25616406 BACKGROUND

• Soto-Iglesias D, Butakoff C, Andreu D, Fernandez-Armenta J, Berruezo A, Camara O. Integration of electro-anatomical and imaging data of the left ventricle: An evaluation framework. Med Image Anal. 2016 Aug;32:131-44. doi: 10.1016/j.media.2016.03.010. Epub 2016 Apr 4.

  PMID: 27086166 BACKGROUND

• Porras AR, Piella G, Berruezo A, Fernandez-Armenta J, Frangi AF. Pre to Intraoperative Data Fusion Framework for Multimodal Characterization of Myocardial Scar Tissue. IEEE J Transl Eng Health Med. 2014 Sep 4;2:1900211. doi: 10.1109/JTEHM.2014.2354332. eCollection 2014.

  PMID: 27170873 BACKGROUND

• Sapp JL, Wells GA, Parkash R, Stevenson WG, Blier L, Sarrazin JF, Thibault B, Rivard L, Gula L, Leong-Sit P, Essebag V, Nery PB, Tung SK, Raymond JM, Sterns LD, Veenhuyzen GD, Healey JS, Redfearn D, Roux JF, Tang AS. Ventricular Tachycardia Ablation versus Escalation of Antiarrhythmic Drugs. N Engl J Med. 2016 Jul 14;375(2):111-21. doi: 10.1056/NEJMoa1513614. Epub 2016 May 5.

  PMID: 27149033 BACKGROUND

• Yamashita S, Cochet H, Sacher F, Mahida S, Berte B, Hooks D, Sellal JM, Al Jefairi N, Frontera A, Komatsu Y, Lim HS, Amraoui S, Denis A, Derval N, Sermesant M, Laurent F, Hocini M, Haissaguerre M, Montaudon M, Jais P. Impact of New Technologies and Approaches for Post-Myocardial Infarction Ventricular Tachycardia Ablation During Long-Term Follow-Up. Circ Arrhythm Electrophysiol. 2016 Jul;9(7):e003901. doi: 10.1161/CIRCEP.116.003901.

  PMID: 27406604 BACKGROUND

• Piers SR, Tao Q, de Riva Silva M, Siebelink HM, Schalij MJ, van der Geest RJ, Zeppenfeld K. CMR-based identification of critical isthmus sites of ischemic and nonischemic ventricular tachycardia. JACC Cardiovasc Imaging. 2014 Aug;7(8):774-84. doi: 10.1016/j.jcmg.2014.03.013. Epub 2014 Jul 16.

  PMID: 25051947 BACKGROUND

• Lilli A, Parollo M, Mazzocchetti L, De Sensi F, Rossi A, Notarstefano P, Santoro A, Aquaro GD, Cresti A, Lapira F, Faggioni L, Tessa C, Pauselli L, Bongiorni MG, Berruezo A, Zucchelli G. Ventricular tachycardia ablation guided or aided by scar characterization with cardiac magnetic resonance: rationale and design of VOYAGE study. BMC Cardiovasc Disord. 2022 Apr 14;22(1):169. doi: 10.1186/s12872-022-02581-1.

  PMID: 35421939 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GIULIO ZUCCHELLI, MD, PhD

  Azienda Ospedaliero, Universitaria Pisana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Prospective, randomized, multicentric open-label study with control group. Superiority of VT ablation including myocardial scar characterization (group 1+2) in comparison with only EAM-guided ablation (group 3: control) in terms of 12-months freedom of recurrences, will be evaluated as primary hypothesis.

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 5, 2021
• Study Start: August 3, 2020
• Primary Completion: July 17, 2025
• Study Completion: July 17, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

IT (7)