Ablation-Index Guided Ventricular Tachycardia Ablations

Ventricular Tachycardia Clinical Trial

Official title:

Ablation-Index Guided Ventricular Tachycardia Ablation in Patients With Ischemic Cardiomyopathy - a Prospective, Multicenter Registry.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06051994
• Other study ID #: ORA 23032805
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: November 2029

Study information

• Verified date: February 2024
• Source: Rush University Medical Center
• Contact: Henry D Huang, MD
• Phone: +1 312-942-5020
• Email: henry_d_huang[@]rush.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

Over the last decade, radiofrequency catheter ablation (RFCA) has become an established treatment for ventricular arrhythmias (VA). RFCA uses electromagnetic energy that transforms into heat upon delivery into the myocardium and irreversibly damages the viable myocytes, causing the loss of cellular excitability. Irreversible loss of cellular excitability generally occurs at temperatures exceeding 50°C, while at lower temperatures, the damage is not permanent and myocytes can recover excitability, leading to VA recurrences. 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 fall in local impedance during ablation has been considered as a first marker of the direct effect of ablation in cardiac tissue but the generator impedance drop does not correlate well with lesion size. First, large impedance drops can indicate impeding steam pop without effective lesion formation. Second scar tissue carries a lower impedance than healthy tissue due to their higher water/collagen content and make impedance drops less reliable. One of the major determinants of lesion formation is an adequate contact between the tip of the catheter and the myocardial surface. A first major technological advancement in ablation catheters was the development of sensors at the distal tip capable of monitoring contact (contact force, CF). A recent ablation marker is the Force-Time-Integral (FTI), which multiplies CF by radiofrequency application duration. Limitations in this ablation parameter are the exclusion of maximal power settings being delivered and the assumption that a single target FTI is required in all myocardial segments with varying wall thickness and underlying substrate. Also for prolonged energy deliveries, the contribution of radiofrequency application duration is proportionally less important in lesion creation than CF1. To overcome some of these limitations, the Ablation Index (AI) was introduced. This is a variable incorporating power delivery in its formula and combining it with CF and time in a weighted equation. It has shown to be a more precise estimation of lesion depth and quality in animal models and humans1 than FTI, time alone or impedance drop. 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, with mainly research conducted in ex-vivo porcine or canine models. In theory, use of AI to guide ablation in this subpopulation of VT patients may shorten procedure time and improve procedural safety in comparison to ablation guided by less reliable conventional parameters or fixed energy application durations. The available research assessing AI-guided VT ablations in patients with structural heart diseased focused on procedural parameters and did not deliver any clinically/prognostic relevant data. While there has been a technological advancement in the monitoring and titration of energy delivered to yield effective RF lesion formation, the application of these tools have been scarcely investigated and implemented in the practice of VT ablation. Since VT recurrence in patients treated with RFCA can be related, at least partly, to inadequate RF lesion formation, it is imperative to continue to explore the need for robust, transferrable markers of ablation efficacy. Further, longer procedure time and time under general anesthesia during VT ablation procedures have been associated with higher procedural morbidity. Thus, a means of concurrently shortening procedure time while maintaining clinical effectiveness may together improve overall outcomes in patients with structural heart disease who undergo VT ablation. The present study will aim at clarifying the efficacy and safety of one of these markers of ablation efficacy, the ablation-index, in a large cohort of patients undergoing VA, thereby providing the first long-term registry on this particular ablation procedure.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiomyopathies
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Arrythmia
• Ventricular Tachycardia

Intervention

Device:
• AI-guided VA ablation
Ablation of ventricular arrhythmia as guided by the ablation index, using Carto 3 electroanatomic mapping system, QDOT Micro ablation catheter, and multipolar mapping catheters (Optrell, Decanav)

Locations

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

Sponsors (5)

Lead Sponsor	Collaborator
Rush University Medical Center	Biosense Webster, Inc., Medical University of South Carolina, The Cleveland Clinic, University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (6)

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

Outcome

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