Ventricular Tachycardia Clinical Trial
Official title:
Ablation-Index Guided Ventricular Tachycardia Ablation in Patients With Ischemic Cardiomyopathy - a Prospective, Multicenter Registry.
Over the last decade, radiofrequency catheter ablation (RFCA) has become an established treatment for ventricular arrhythmias (VA). Due to the challenging nature of visualizing lesion formation in real time and ensuring an effective transmural lesion, different surrogate measures of lesion quality have been used. The Ablation Index (AI) is a variable incorporating power delivery in its formula and combining it with CF and time in a weighted equation which aims at allowing for a more precise estimation of lesion depth and quality when ablating VAs. AI guidance has previously been shown to improve outcomes in atrial and ventricular ablation in patients with premature ventricular complexes (PVC). However research on outcomes following AI-guidance for VT ablation specifically in patients with structural disease and prior myocardial infarction remains sparse. We aim at conducting a prospective observational multicenter registry investigating the efficacy and safety of AI-guided VA ablation in patient with ischemic and non-ischemic cardiomyopathy.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | November 2029 |
Est. primary completion date | November 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient = 18 y.o. - Structural Heart Disease: Ischemic Cardiomyopathy - Sustained Scar-related Monomorphic Ventricular Tachycardia documented by ECG or CIED interrogation Exclusion Criteria: - If clinical ventricular arrhythmia is predominantly PVCs, polymorphic ventricular tachycardia, or ventricular fibrillation - Myocardial infarction or Cardiac Surgery within 6 months - Severe mitral regurgitation - Stroke or TIA within 6 months - Prior Ventricular Tachycardia Ablation |
Country | Name | City | State |
---|---|---|---|
United States | Medical University of Michigan | Ann Arbor | Michigan |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Rush University Medical Center | Chicago | Illinois |
United States | Cleveland Clinic | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Rush University Medical Center | Biosense Webster, Inc., Medical University of South Carolina, The Cleveland Clinic, University of Michigan |
United States,
Bates AP, Paisey J, Yue A, Banks P, Roberts PR, Ullah W. Radiofrequency Ablation of the Diseased Human Left Ventricle: Biophysical and Electrogram-Based Analysis. JACC Clin Electrophysiol. 2023 Mar;9(3):330-340. doi: 10.1016/j.jacep.2022.10.001. Epub 2022 Oct 10. — View Citation
Casella M, Gasperetti A, Gianni C, Zucchelli G, Notarstefano P, Al-Ahmad A, Burkhardt JD, Soldati E, Della Rocca D, Catto V, Majocchi B, Carbucicchio C, Bongiorni MG, Dello Russo A, Natale A, Tondo C. Ablation Index as a predictor of long-term efficacy in premature ventricular complex ablation: A regional target value analysis. Heart Rhythm. 2019 Jun;16(6):888-895. doi: 10.1016/j.hrthm.2019.01.005. Epub 2019 Jan 4. — View Citation
Gasperetti A, Sicuso R, Dello Russo A, Zucchelli G, Saguner AM, Notarstefano P, Soldati E, Bongiorni MG, Della Rocca DG, Mohanty S, Carbucicchio C, Duru F, Di Biase L, Natale A, Tondo C, Casella M. Prospective use of ablation index for the ablation of right ventricle outflow tract premature ventricular contractions: a proof of concept study. Europace. 2021 Jan 27;23(1):91-98. doi: 10.1093/europace/euaa228. — View Citation
Hussein A, Das M, Riva S, Morgan M, Ronayne C, Sahni A, Shaw M, Todd D, Hall M, Modi S, Natale A, Dello Russo A, Snowdon R, Gupta D. Use of Ablation Index-Guided Ablation Results in High Rates of Durable Pulmonary Vein Isolation and Freedom From Arrhythmia in Persistent Atrial Fibrillation Patients: The PRAISE Study Results. Circ Arrhythm Electrophysiol. 2018 Sep;11(9):e006576. doi: 10.1161/CIRCEP.118.006576. — View Citation
Larsen T, Du-Fay-de-Lavallaz JM, Winterfield JR, Ravi V, Rhodes P, Wasserlauf J, Trohman RG, Sharma PS, Huang HD. Comparison of ablation index versus time-guided radiofrequency energy dosing using normal and half-normal saline irrigation in a porcine left ventricular model. J Cardiovasc Electrophysiol. 2022 Apr;33(4):698-712. doi: 10.1111/jce.15379. Epub 2022 Jan 30. — View Citation
Proietti R, Lichelli L, Lellouche N, Dhanjal T. The challenge of optimising ablation lesions in catheter ablation of ventricular tachycardia. J Arrhythm. 2020 Dec 28;37(1):140-147. doi: 10.1002/joa3.12489. eCollection 2021 Feb. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Procedure duration | Total duration of the procedure from injection of lidocaine to removal of sheaths | intra-procedural | |
Secondary | Fluoroscopy time | Total fluoroscopy time of the procedure | intra-procedural | |
Secondary | Number of RF applications | Median/mean number of RF applications used per patient during the procedure | intra-procedural | |
Secondary | Total RF duration | Total duration of radiofrequency ablation during the procedure | intra-procedural | |
Secondary | Average RF time per lesion | Average duration of radiofrequency application per lesion | intra-procedural | |
Secondary | Ablation index per lesion | Average ablation index per lesion | intra-procedural | |
Secondary | Impedance drop from baseline per lesion | Average of the impedance drop from baseline for each lesion | intra-procedural | |
Secondary | Acute procedural success | Acute freedom from VT (non-inducibility of clinical VT, non-inducibility of any VT, elimination of late potentials and each component separately) | intra-procedural | |
Secondary | Complications (composite) | Rate of complications within 7 days after procedure of a composite safety outcome including bleeding (major and minor), death, pericardial effusion, cardiac tamponade, stroke, arterial thromboembolism, steam pops, thrombus formation, cardiogenic shock, phrenic nerve paralysis, congestive heart failure | 7 days | |
Secondary | Complications (single elements) | Rate of complications within 7 days after procedure of a components of a safety outcome including bleeding (major and minor), death, pericardial effusion, cardiac tamponade, stroke, arterial thromboembolism, steam pops, thrombus formation, cardiogenic shock, phrenic nerve paralysis, congestive heart failure | 7 days | |
Secondary | Recurrence of Sustained Ventricular Tachycardia or ICD therapy | Recurrence of a sustained VT or need for ICD therapy up to 1 year (time-to-failure analysis as well as cumulative analysis) | 1 year | |
Secondary | Hospitalization for Ventricular Tachycardia | Hospitalization for Ventricular Tachycardia up to 1 year (time-to-failure analysis as well as cumulative analysis) | 1 year | |
Secondary | Outcome of death after ablation procedure from cardiovascular or non-cardiovascular cause | Overall death up to 1-year (cardiovascular and non-cardiovascular as well as single components separately) | 1 year | |
Secondary | Outcome of repeat ablation procedure for sustained ventricular tachycardia or appropriate ICD therapy after index ventricular tachycardia ablation procedure | Outcome of repeat ablation procedure for sustained ventricular tachycardia or appropriate ICD therapy after index ventricular tachycardia ablation procedure at 1 year (time-to-failure analysis as well as cumulative analysis) | 1 year | |
Secondary | Drug prescription pattern | Prescription pattern of anti-arrhythmic drugs (amiodarone, sotalol, mexilitene, quinidine, disopyramide) before and after ablation in the cohort | 1 year | |
Secondary | Feasibility of AI-guided ablation (objective) | Assessment of the number of applied lesions failing protocol restrictions of an AI cut-off of 550 ± 55 (10% variation allowed) | intra-procedural | |
Secondary | Feasibility of AI-guided ablation (subjective) | Assessment of proceduralist comfort and learning curve through repeating surveys after 10, 25 procedures | intra-procedural | |
Secondary | Numerical AI differences in patients experiencing a VT recurrence in the follow-up versus patients not experiencing any recurrences | Median, maximal, minimal and median of the maximal AI applications in patients experience or not a VT recurrence in the follow-up | 1 year |
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