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

NCT ID: NCT06543173

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2030-08-01

Brief Summary

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Prophylactic Catheter-based VT Ablation

Subjects receive catheter-based ventricular tachycardia (VT) ablation within 3 months of primary ICD implantation.

Group Type: EXPERIMENTAL

Prophylactic Catheter-based VT Ablation

Intervention Type: PROCEDURE

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).

Continued Medical Management

Subjects undergo continued medical management after primary ICD implantation without prophylactic VT ablation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Ilan Goldenberg

Ilan Goldenberg, MD, Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ilan Goldenberg, MD

Role: CONTACT

Ilan.Goldenberg@heart.rochester.edu

585-275-5391

Nicole Guerrero, MBA

Role: CONTACT

Nicole.Guerrero@heart.rochester.edu

References

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 UB, Tzou WS, Varma N, Zeppenfeld K. 2019 HRS/EHRA/APHRS/LAHRS expert consensus statement on catheter ablation of ventricular arrhythmias: Executive summary. Heart Rhythm. 2020 Jan;17(1):e155-e205. doi: 10.1016/j.hrthm.2019.03.014. Epub 2019 May 10.

Reference Type: BACKGROUND

PMID: 31102616 (View on PubMed)

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 Dec 6.

Reference Type: BACKGROUND

PMID: 15583079 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18768944 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11827924 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19929037 (View on PubMed)

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 their families: a scientific statement from the American Heart Association. Circulation. 2012 Oct 23;126(17):2146-72. doi: 10.1161/CIR.0b013e31825d59fd. Epub 2012 Sep 24.

Reference Type: BACKGROUND

PMID: 23008437 (View on PubMed)

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 recurrent ventricular tachycardia after catheter ablation is associated with improved survival in patients with structural heart disease: An International VT Ablation Center Collaborative Group study. Heart Rhythm. 2015 Sep;12(9):1997-2007. doi: 10.1016/j.hrthm.2015.05.036. Epub 2015 May 30.

Reference Type: BACKGROUND

PMID: 26031376 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21539642 (View on PubMed)

Dinov B, Arya A, Bertagnolli L, Schirripa V, Schoene K, Sommer P, Bollmann A, Rolf S, Hindricks G. Early referral for ablation of scar-related ventricular tachycardia is associated with improved acute and long-term outcomes: results from the Heart Center of Leipzig ventricular tachycardia registry. Circ Arrhythm Electrophysiol. 2014 Dec;7(6):1144-51. doi: 10.1161/CIRCEP.114.001953. Epub 2014 Sep 27.

Reference Type: BACKGROUND

PMID: 25262159 (View on PubMed)

Reddy VY, Reynolds MR, Neuzil P, Richardson AW, Taborsky M, Jongnarangsin K, Kralovec S, Sediva L, Ruskin JN, Josephson ME. Prophylactic catheter ablation for the prevention of defibrillator therapy. N Engl J Med. 2007 Dec 27;357(26):2657-65. doi: 10.1056/NEJMoa065457.

Reference Type: BACKGROUND

PMID: 18160685 (View on PubMed)

Kuck KH, Schaumann A, Eckardt L, Willems S, Ventura R, Delacretaz E, Pitschner HF, Kautzner J, Schumacher B, Hansen PS; VTACH study group. Catheter ablation of stable ventricular tachycardia before defibrillator implantation in patients with coronary heart disease (VTACH): a multicentre randomised controlled trial. Lancet. 2010 Jan 2;375(9708):31-40. doi: 10.1016/S0140-6736(09)61755-4.

Reference Type: BACKGROUND

PMID: 20109864 (View on PubMed)

Kuck KH, Tilz RR, Deneke T, Hoffmann BA, Ventura R, Hansen PS, Zarse M, Hohnloser SH, Kautzner J, Willems S; SMS Investigators. Impact of Substrate Modification by Catheter Ablation on Implantable Cardioverter-Defibrillator Interventions in Patients With Unstable Ventricular Arrhythmias and Coronary Artery Disease: Results From the Multicenter Randomized Controlled SMS (Substrate Modification Study). Circ Arrhythm Electrophysiol. 2017 Mar;10(3):e004422. doi: 10.1161/CIRCEP.116.004422.

Reference Type: BACKGROUND

PMID: 28292751 (View on PubMed)

Willems S, Tilz RR, Steven D, Kaab S, Wegscheider K, Geller L, Meyer C, Heeger CH, Metzner A, Sinner MF, Schluter M, Nordbeck P, Eckardt L, Bogossian H, Sultan A, Wenzel B, Kuck KH; BERLIN VT Investigators. Preventive or Deferred Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy and Implantable Defibrillator (BERLIN VT): A Multicenter Randomized Trial. Circulation. 2020 Mar 31;141(13):1057-1067. doi: 10.1161/CIRCULATIONAHA.119.043400. Epub 2020 Jan 31.

Reference Type: BACKGROUND

PMID: 32000514 (View on PubMed)

Della Bella P, Baratto F, Vergara P, Bertocchi P, Santamaria M, Notarstefano P, Calo L, Orsida D, Tomasi L, Piacenti M, Sangiorgio S, Pentimalli F, Pruvot E, De Sousa J, Sacher F, Tritto M, Rebellato L, Deneke T, Romano SA, Nesti M, Gargaro A, Giacopelli D, Peretto G, Radinovic A. Does Timing of Ventricular Tachycardia Ablation Affect Prognosis in Patients With an Implantable Cardioverter Defibrillator? Results From the Multicenter Randomized PARTITA Trial. Circulation. 2022 Jun 21;145(25):1829-1838. doi: 10.1161/CIRCULATIONAHA.122.059598. Epub 2022 Apr 3.

Reference Type: BACKGROUND

PMID: 35369700 (View on PubMed)

Goldenberg I, Maury P, Huang DT, Aktas M, Sacher F, Clementy N, Mulpuru S, Friedman P, Meyer C, Tiefenbrun NL, McNitt S, Zareba W, Nof E. Hybrid VT Ablation-Subcutaneous ICD Management Strategy for Secondary Prevention of Sudden Cardiac Death: The VTabl-SICD Trial. Heart Rhythm 2023 (in press).

Reference Type: BACKGROUND

Younis A, Goldberger JJ, Kutyifa V, Zareba W, Polonsky B, Klein H, Aktas MK, Huang D, Daubert J, Estes M, Cannom D, McNitt S, Stein K, Goldenberg I. Predicted benefit of an implantable cardioverter-defibrillator: the MADIT-ICD benefit score. Eur Heart J. 2021 May 1;42(17):1676-1684. doi: 10.1093/eurheartj/ehaa1057.

Reference Type: BACKGROUND

PMID: 33417692 (View on PubMed)

Zeppenfeld K, Tfelt-Hansen J, de Riva M, Winkel BG, Behr ER, Blom NA, Charron P, Corrado D, Dagres N, de Chillou C, Eckardt L, Friede T, Haugaa KH, Hocini M, Lambiase PD, Marijon E, Merino JL, Peichl P, Priori SG, Reichlin T, Schulz-Menger J, Sticherling C, Tzeis S, Verstrael A, Volterrani M; ESC Scientific Document Group. 2022 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Eur Heart J. 2022 Oct 21;43(40):3997-4126. doi: 10.1093/eurheartj/ehac262. No abstract available.

Reference Type: BACKGROUND

PMID: 36017572 (View on PubMed)

Arenal A, Glez-Torrecilla E, Ortiz M, Villacastin J, Fdez-Portales J, Sousa E, del Castillo S, Perez de Isla L, Jimenez J, Almendral J. Ablation of electrograms with an isolated, delayed component as treatment of unmappable monomorphic ventricular tachycardias in patients with structural heart disease. J Am Coll Cardiol. 2003 Jan 1;41(1):81-92. doi: 10.1016/s0735-1097(02)02623-2.

Reference Type: BACKGROUND

PMID: 12570949 (View on PubMed)

Jais P, Maury P, Khairy P, Sacher F, Nault I, Komatsu Y, Hocini M, Forclaz A, Jadidi AS, Weerasooryia R, Shah A, Derval N, Cochet H, Knecht S, Miyazaki S, Linton N, Rivard L, Wright M, Wilton SB, Scherr D, Pascale P, Roten L, Pederson M, Bordachar P, Laurent F, Kim SJ, Ritter P, Clementy J, Haissaguerre M. Elimination of local abnormal ventricular activities: a new end point for substrate modification in patients with scar-related ventricular tachycardia. Circulation. 2012 May 8;125(18):2184-96. doi: 10.1161/CIRCULATIONAHA.111.043216. Epub 2012 Apr 4.

Reference Type: BACKGROUND

PMID: 22492578 (View on PubMed)

Irie T, Yu R, Bradfield JS, Vaseghi M, Buch EF, Ajijola O, Macias C, Fujimura O, Mandapati R, Boyle NG, Shivkumar K, Tung R. Relationship between sinus rhythm late activation zones and critical sites for scar-related ventricular tachycardia: systematic analysis of isochronal late activation mapping. Circ Arrhythm Electrophysiol. 2015 Apr;8(2):390-9. doi: 10.1161/CIRCEP.114.002637. Epub 2015 Mar 4.

Reference Type: BACKGROUND

PMID: 25740836 (View on PubMed)

Aziz Z, Shatz D, Raiman M, Upadhyay GA, Beaser AD, Besser SA, Shatz NA, Fu Z, Jiang R, Nishimura T, Liao H, Nayak HM, Tung R. Targeted Ablation of Ventricular Tachycardia Guided by Wavefront Discontinuities During Sinus Rhythm: A New Functional Substrate Mapping Strategy. Circulation. 2019 Oct 22;140(17):1383-1397. doi: 10.1161/CIRCULATIONAHA.119.042423. Epub 2019 Sep 19.

Reference Type: BACKGROUND

PMID: 31533463 (View on PubMed)

Di Biase L, Santangeli P, Burkhardt DJ, Bai R, Mohanty P, Carbucicchio C, Dello Russo A, Casella M, Mohanty S, Pump A, Hongo R, Beheiry S, Pelargonio G, Santarelli P, Zucchetti M, Horton R, Sanchez JE, Elayi CS, Lakkireddy D, Tondo C, Natale A. Endo-epicardial homogenization of the scar versus limited substrate ablation for the treatment of electrical storms in patients with ischemic cardiomyopathy. J Am Coll Cardiol. 2012 Jul 10;60(2):132-41. doi: 10.1016/j.jacc.2012.03.044.

Reference Type: BACKGROUND

PMID: 22766340 (View on PubMed)

Soejima K, Stevenson WG, Maisel WH, Sapp JL, Epstein LM. Electrically unexcitable scar mapping based on pacing threshold for identification of the reentry circuit isthmus: feasibility for guiding ventricular tachycardia ablation. Circulation. 2002 Sep 24;106(13):1678-83. doi: 10.1161/01.cir.0000030187.39852.a7.

Reference Type: BACKGROUND

PMID: 12270862 (View on PubMed)

Tzou WS, Frankel DS, Hegeman T, Supple GE, Garcia FC, Santangeli P, Katz DF, Sauer WH, Marchlinski FE. Core isolation of critical arrhythmia elements for treatment of multiple scar-based ventricular tachycardias. Circ Arrhythm Electrophysiol. 2015 Apr;8(2):353-61. doi: 10.1161/CIRCEP.114.002310. Epub 2015 Feb 13.

Reference Type: BACKGROUND

PMID: 25681389 (View on PubMed)

Brunckhorst CB, Stevenson WG, Soejima K, Maisel WH, Delacretaz E, Friedman PL, Ben-Haim SA. Relationship of slow conduction detected by pace-mapping to ventricular tachycardia re-entry circuit sites after infarction. J Am Coll Cardiol. 2003 Mar 5;41(5):802-9. doi: 10.1016/s0735-1097(02)02932-7.

Reference Type: BACKGROUND

PMID: 12628726 (View on PubMed)

de Chillou C, Groben L, Magnin-Poull I, Andronache M, MagdiAbbas M, Zhang N, Abdelaal A, Ammar S, Sellal JM, Schwartz J, Brembilla-Perrot B, Aliot E, Marchlinski FE. Localizing the critical isthmus of postinfarct ventricular tachycardia: the value of pace-mapping during sinus rhythm. Heart Rhythm. 2014 Feb;11(2):175-81. doi: 10.1016/j.hrthm.2013.10.042.

Reference Type: BACKGROUND

PMID: 24513915 (View on PubMed)

Goldenberg I, Huang D, McNitt S, Zareba W, Aktas M, Kutyifa V. History of non-sustained ventricular tachycardia and the risk of arrhythmic events in patients with a primary prevention ICD. Heart Rhythm Scientific Sessions, 2024.

Reference Type: BACKGROUND

Gopinathannair R, Cornwell WK, Dukes JW, Ellis CR, Hickey KT, Joglar JA, Pagani FD, Roukoz H, Slaughter MS, Patton KK. Device Therapy and Arrhythmia Management in Left Ventricular Assist Device Recipients: A Scientific Statement From the American Heart Association. Circulation. 2019 May 14;139(20):e967-e989. doi: 10.1161/CIR.0000000000000673.

Reference Type: BACKGROUND

PMID: 30943783 (View on PubMed)

Jamil DD, Baram A, Saqat BH. Impact of prolonged cardiopulmonary bypass and operative exposure time on the incidence of surgical site infections in patients undergoing open heart surgery: Single center case series. International Journal of Surgery Open, 2020;22:52-56.

Reference Type: BACKGROUND

Brown WR, Moody DM, Challa VR, Stump DA, Hammon JW. Longer duration of cardiopulmonary bypass is associated with greater numbers of cerebral microemboli. Stroke. 2000 Mar;31(3):707-13. doi: 10.1161/01.str.31.3.707.

Reference Type: BACKGROUND

PMID: 10700508 (View on PubMed)

Mehra MR, Uriel N, Naka Y, Cleveland JC Jr, Yuzefpolskaya M, Salerno CT, Walsh MN, Milano CA, Patel CB, Hutchins SW, Ransom J, Ewald GA, Itoh A, Raval NY, Silvestry SC, Cogswell R, John R, Bhimaraj A, Bruckner BA, Lowes BD, Um JY, Jeevanandam V, Sayer G, Mangi AA, Molina EJ, Sheikh F, Aaronson K, Pagani FD, Cotts WG, Tatooles AJ, Babu A, Chomsky D, Katz JN, Tessmann PB, Dean D, Krishnamoorthy A, Chuang J, Topuria I, Sood P, Goldstein DJ; MOMENTUM 3 Investigators. A Fully Magnetically Levitated Left Ventricular Assist Device - Final Report. N Engl J Med. 2019 Apr 25;380(17):1618-1627. doi: 10.1056/NEJMoa1900486. Epub 2019 Mar 17.

Reference Type: BACKGROUND

PMID: 30883052 (View on PubMed)

Other Identifiers

STUDY00009548

Identifier Type: -

Identifier Source: org_study_id