Primary Preventive Ventricular Tachycardia Ablation In High-Risk Patients Who Receive A Prophylactic Implantable Cardioverter Defibrillator

Official title

Primary Preventive Ventricular Tachycardia Ablation In High-Risk Patients Who Receive A Prophylactic Implantable Cardioverter Defibrillator (PRIMARY PREVENT-VT TRIAL)

Overview

This prospective, multicenter, open-label, randomized-controlled trial compares two treatment strategies in high-risk ischemic cardiomyopathy (ICM) patients referred for primary ICD implantation. Participants will be randomized to receive either prophylactic VT ablation within three months of ICD implantation or continued medical management. The primary objective is to assess the efficacy of preventive VT ablation versus medical management in reducing VT arrhythmia burden.

Detailed description

This study aims to assess the impact of prophylactic catheter-based ventricular tachycardia (VT) ablation compared to medical management in high-risk patients with ischemic cardiomyopathy (ICM) undergoing primary implantable cardioverter defibrillator (ICD) implantation. The primary outcome measure is the burden of VT arrhythmias (VTA), defined as the total number of VT events, one year post-ICD implantation. The hypothesis suggests that employing VT ablation with high-density electroanatomic mapping (EnsiteTM) will significantly reduce both treated and monitored VT episodes. The study will randomize 62 participants in a 1:1 ratio across 20 experienced sites in Europe.

Interventions

• Procedure Prophylactic Catheter-based VT Ablation
  Prophylactic Catheter-based VT Ablation refers to a treatment strategy where participants undergo a procedure known as catheter-based ventricular tachycardia (VT) ablation shortly after receiving their primary implantable cardioverter defibrillator (ICD).

Primary outcome measures

• Total Number of VT Arrhythmia Events in High-Risk Patients with Ischemic Cardiomyopathy (ICM) After Primary ICD Implantation: Comparison of Preventive Catheter-Based VT Ablation Versus Medical Management. [Time frame: One year following ICD implantation.]

Secondary outcome measures (1)

• Impact of Preventive VT Ablation on Healthcare Utilization, assessed using the mean rate of events per arm. [Time frame: One year following ICD implantation.]

Eligibility criteria

Inclusion criteria

• Age ≥ 18 years (no upper age limit)
• Willing and able to provide informed consent
• Candidate for a primary prevention ICD/CRT-D per ESC guidelines17
• Ischemic cardiomyopathy (ICM) with left ventricular ejection fraction (LVEF) ≤ 35%
• Willing and able to receive an ICD
• Willing and able to undergo catheter-based VT ablation

One or more of the following:

• MADIT-ICD Benefit Score >75
• History of nonsustained ventricular tachycardia (NSVT)
• Multiple premature ventricular complexes (PVCs ≥10%)

Exclusion criteria

• Existing ICD or CRT-D
• History of sustained VT or VF
• Chronic renal failure requiring hemodialysis
• Coronary revascularization within the past 3 months
• ST-Elevation MI within the past 3 months
• Participation in concurrent clinical trials without approval from the Coordination Center (observational registries are allowed with approval)
• Currently pregnant or planning to become pregnant in the near future
• Inability or unwillingness to adhere to the study protocol
• Inability or unwillingness to provide informed consent for participation
• Life expectancy < 1 year

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

France · 3 centers

• Centre Hospitalier De Pau — Pau
• Hopital Trousseau Chru de Tours — Chambray-lès-Tours
• Centre Hospitalier Universitaire de Bordeaux — Pessac

Denmark · 1 center

• Righospitalet — Copenhagen

Spain · 1 center

• Unidad de Arritimias, Hospital Clínic Barcelona — Barcelona

Publications

• Cronin EM, Bogun FM, Maury P, Peichl P, Chen M, Namboodiri N, Aguinaga L, Leite LR, Al-Khatib SM, Anter E, Berruezo A, Callans DJ, Chung MK, Cuculich P, d'Avila A, Deal BJ, Della Bella P, Deneke T, Dickfeld TM, Hadid C, Haqqani HM, Kay GN, Latchamsetty R, Marchlinski F, Miller JM, Nogami A, Patel AR, Pathak RK, Saenz Morales LC, Santangeli P, Sapp JL Jr, Sarkozy A, Soejima K, Stevenson WG, Tedrow PMID 31102616
• Moss AJ, Greenberg H, Case RB, Zareba W, Hall WJ, Brown MW, Daubert JP, McNitt S, Andrews ML, Elkin AD; Multicenter Automatic Defibrillator Implantation Trial-II (MADIT-II) Research Group. Long-term clinical course of patients after termination of ventricular tachyarrhythmia by an implanted defibrillator. Circulation. 2004 Dec 21;110(25):3760-5. doi: 10.1161/01.CIR.0000150390.04704.B7. Epub 2004 D PMID 15583079
• Poole JE, Johnson GW, Hellkamp AS, Anderson J, Callans DJ, Raitt MH, Reddy RK, Marchlinski FE, Yee R, Guarnieri T, Talajic M, Wilber DJ, Fishbein DP, Packer DL, Mark DB, Lee KL, Bardy GH. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med. 2008 Sep 4;359(10):1009-17. doi: 10.1056/NEJMoa071098. PMID 18768944
• Schron EB, Exner DV, Yao Q, Jenkins LS, Steinberg JS, Cook JR, Kutalek SP, Friedman PL, Bubien RS, Page RL, Powell J. Quality of life in the antiarrhythmics versus implantable defibrillators trial: impact of therapy and influence of adverse symptoms and defibrillator shocks. Circulation. 2002 Feb 5;105(5):589-94. doi: 10.1161/hc0502.103330. PMID 11827924
• Noyes K, Corona E, Veazie P, Dick AW, Zhao H, Moss AJ. Examination of the effect of implantable cardioverter-defibrillators on health-related quality of life: based on results from the Multicenter Automatic Defibrillator Trial-II. Am J Cardiovasc Drugs. 2009;9(6):393-400. doi: 10.2165/11317980-000000000-00000. PMID 19929037
• Dunbar SB, Dougherty CM, Sears SF, Carroll DL, Goldstein NE, Mark DB, McDaniel G, Pressler SJ, Schron E, Wang P, Zeigler VL; American Heart Association Council on Cardiovascular Nursing, Council on Clinical Cardiology, and Council on Cardiovascular Disease in the Young. Educational and psychological interventions to improve outcomes for recipients of implantable cardioverter defibrillators and the PMID 23008437
• Tung R, Vaseghi M, Frankel DS, Vergara P, Di Biase L, Nagashima K, Yu R, Vangala S, Tseng CH, Choi EK, Khurshid S, Patel M, Mathuria N, Nakahara S, Tzou WS, Sauer WH, Vakil K, Tedrow U, Burkhardt JD, Tholakanahalli VN, Saliaris A, Dickfeld T, Weiss JP, Bunch TJ, Reddy M, Kanmanthareddy A, Callans DJ, Lakkireddy D, Natale A, Marchlinski F, Stevenson WG, Della Bella P, Shivkumar K. Freedom from recu PMID 26031376
• Frankel DS, Mountantonakis SE, Robinson MR, Zado ES, Callans DJ, Marchlinski FE. Ventricular tachycardia ablation remains treatment of last resort in structural heart disease: argument for earlier intervention. J Cardiovasc Electrophysiol. 2011 Oct;22(10):1123-8. doi: 10.1111/j.1540-8167.2011.02081.x. Epub 2011 May 3. PMID 21539642

Identifiers

NCT: NCT06543173 · STUDY00009548

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗