Ventricular Tachycardia Clinical Trial
— VOYAGEOfficial title:
VOYAGE- Ventricular Tachycardia Ablation and Myocardial Scar Characterization With Magnetic Resonance
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 we know - 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
Status | Recruiting |
Enrollment | 103 |
Est. completion date | August 3, 2023 |
Est. primary completion date | August 3, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda USL Toscana Sud Est | Arezzo | AR |
Italy | Azienda USL Toscana Nord Ovest - U.O.C. Cardiologia, Ospedale Versilia | Camaiore | LU |
Italy | Azienda USL Toscana Sud Est- U.O.C. Cardiologia, Ospedale Misericordia - Grosseto | GRosseto | GR |
Italy | Azienda USL Toscana Nord Ovest- U.O.C. Cardiologia, Ospedali Riuniti - Livorno | Livorno | LI |
Italy | AOUPisana | Pisa | PI |
Italy | FTGM | Pisa | PI |
Italy | Azienda Ospedaliero Universitaria Senese - U.O.C. Cardiologia, Siena | Siena | SI |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero, Universitaria Pisana | Azienda Ospedaliera Universitaria Senese, Azienda USL Toscana Nord Ovest, Azienda USL Toscana Sud Est, Centro Medico Teknon, Fondazione Toscana Gabriele Monasterio |
Italy,
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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. — View Citation
Porras AR, Piella G, Berruezo A, Fernández-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. — View Citation
Priori SG, Blomström-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, Norekvål 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. — View Citation
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. — View Citation
Soto-Iglesias D, Acosta J, Penela D, Fernández-Armenta J, Cabrera M, Martínez M, Vassanelli F, Alcaine A, Linhart M, Jáuregui B, Efimova E, Perea RJ, Prat-González S, Ortiz-Pérez 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. — View Citation
Soto-Iglesias D, Butakoff C, Andreu D, Fernández-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. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VT recurrences | To compare the recurrences of the CMR guided/aided approaches in comparison to control group | 12-month | |
Secondary | Efficiency | To evaluate the efficiency (procedure times, radiofrequency time, fluoroscopy time) of different approaches | 1 month | |
Secondary | VT non-inducibility | To evaluate the VT non-inducibility of different approaches at the end of ablation | 1 month | |
Secondary | Number of participants with Complications | To compare the Number of participants with Complications using a CMR-guided/aided approach in comparison with control group | 12-month | |
Secondary | Rate of ICD interventions | To compare the outcome of the CMR guided/aided approaches of VT ablation in terms of ICD interventions rate per patients with recurrences (ATP or shocks) during 12 months follow-up in comparison to control group | 12-month | |
Secondary | CMR images suitability | To evaluate the possibility to use the CMR images for a CMR-guided/aided approach (rate of patients who had underwent CMR, in whom the images are suitable for a CMR guided/aided approach) | 1 month |
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