Status:
COMPLETED
Ventricular Tachycardia Ablation and Myocardial Scar Characterization With Magnetic Resonance
Lead Sponsor:
Azienda Ospedaliero, Universitaria Pisana
Collaborating Sponsors:
Azienda USL Toscana Nord Ovest
Azienda USL Toscana Sud Est
Conditions:
Ventricular Tachycardia
Myocardial Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 res...
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 rol...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2025
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04694079
Start Date
August 3 2020
End Date
July 17 2025
Last Update
December 15 2025
Active Locations (7)
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1
Azienda USL Toscana Sud Est
Arezzo, AR, Italy
2
Azienda USL Toscana Sud Est- U.O.C. Cardiologia, Ospedale Misericordia - Grosseto
Grosseto, GR, Italy
3
Azienda USL Toscana Nord Ovest- U.O.C. Cardiologia, Ospedali Riuniti - Livorno
Livorno, LI, Italy, 57126
4
Azienda USL Toscana Nord Ovest - U.O.C. Cardiologia, Ospedale Versilia
Camaiore, LU, Italy