The STandard Versus ImAging SuBstrate Aided Ablation in Severe Left VEntricular Dysfunction VT.

NCT05828667 | Withdrawn DMC

• 1 other identifier: 851281
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The STABLE-VT trial aims to determine the safety profile and clinical efficacy of a modified approach to ventricular tachycardia (VT) ablation that integrates myocardial scar as visualized on cardiac magnetic resonance (c-MRI) or CT into electroanatomical mapping (EAM) for VT ablation.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (6)

• Major adverse cardiovascular events (MACE)

  Incidence of major adverse cardiac events, which are cardiovascular death, myocardial infarction, stroke/TIA

  during hospital stay following ablation procedure, up to 1 week

• Number of Participants Requiring Mechanical circulatory support use

  Incidence of mechanical circulatory support (e.g., extra corporeal membrane oxygenation, Impella, LVAD or transplant) use

  During the procedure, 24-48 hours after the ablation procedure

• Number of Participants Requiring Inotropic support use

  Incidence of inotropic and vasoactive agents use

  During the procedure, 24-48 hours after the ablation procedure

• Number of Participants With Clinically Significant Pericardial Effusion

  Assessing clinically significant pericardial effusion causing hemodynamic instability

  During the procedure, up to 24 hours after the ablation procedure

• Number of Participants With Acute kidney injury

  Acute kidney injury (≥50% within 48 hours of the start of the procedure)

  During procedure, up to 24-48 hours after the ablation procedure

• Number of Participants Requiring intubation

  Need for intubation

  During procedure, 24 hours after the ablation procedure

Secondary Outcomes (9)

• Experimental procedural duration

  During procedure

• noninvasive programmed stimulation (NIPS) sub-acutely after the procedure

  24-48 hours after the procedure.

• Mean and peak procedural lactate level

  During procedure

• Cumulative procedural inotropic support use

  During procedure, 24-48 hours after the ablation procedure

• Hospital stay length following the procedure

  Periprocedural hospital stay length, up to 2 weeks

Study Arms (2)

Standard of Care Arm

NO INTERVENTION

Standard of care procedural steps per respective institution and attending physician's clinical practice.

Imaging-aided VT ablation

EXPERIMENTAL

For subjects assigned to the imaging-aided VT ablation arm, CT and/or c-MRI derived myocardial scar will be merged with 3D electroanatomical mapping (EAM) prior to the ablation to allow for readily localization and characterization of VT substrates and potential re-entry circuits to be ablated. This integrated mapping of VT substrates sites to be ablated will be given to the electrophysiologist prior to the ablation.

Other: Incorporation of CT and/or c-MRI derived myocardial scar with 3D electroanatomical mapping (EAM).

Interventions

Incorporation of CT and/or c-MRI derived myocardial scar with 3D electroanatomical mapping (EAM). OTHER

CT and/or c-MRI derived myocardial scar will be merged with 3D electroanatomical mapping (EAM) prior to the ablation to allow for readily localization and characterization of VT substrates and potential re-entry circuits to be ablated. This is done with the intent to limit the repeated number of inductions and prolonged point-by-point voltage mapping that often result in hemodynamic instability.

Imaging-aided VT ablation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (\>18 years old) diagnosed with severely reduced ejection fraction defined as EF≤25% or EF≤ 35% with concurrent NYHA class III/IV heart failure symptoms and/or at least one previous heart failure hospitalization in the previous 6 months) who are referred for VT ablation.
• Patients with moderate to severe RV dysfunction diagnosed on most recent imaging (echo/c-MRI).
• Patients with must have undergone the imaging (c-MRI and/or CT) required for the investigational VT approach to qualify for participation.

You may not qualify if:

• Patients in whom Impella/ECMO or anesthesia is indicated prior to or at presentation to the EP lab.
• Patients for whom an informed consent cannot be obtained.
• Patients who are found to be pregnant using detection of human chorionic gonadotropin (hcg) as done as part of standard of care, will be excluded.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of The University Of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (11)

• Bogun FM, Desjardins B, Good E, Gupta S, Crawford T, Oral H, Ebinger M, Pelosi F, Chugh A, Jongnarangsin K, Morady F. Delayed-enhanced magnetic resonance imaging in nonischemic cardiomyopathy: utility for identifying the ventricular arrhythmia substrate. J Am Coll Cardiol. 2009 Mar 31;53(13):1138-45. doi: 10.1016/j.jacc.2008.11.052.

  PMID: 19324259 BACKGROUND

• Wijnmaalen AP, van der Geest RJ, van Huls van Taxis CF, Siebelink HM, Kroft LJ, Bax JJ, Reiber JH, Schalij MJ, Zeppenfeld K. Head-to-head comparison of contrast-enhanced magnetic resonance imaging and electroanatomical voltage mapping to assess post-infarct scar characteristics in patients with ventricular tachycardias: real-time image integration and reversed registration. Eur Heart J. 2011 Jan;32(1):104-14. doi: 10.1093/eurheartj/ehq345. Epub 2010 Sep 23.

  PMID: 20864488 BACKGROUND

• Andreu D, Berruezo A, Ortiz-Perez JT, Silva E, Mont L, Borras R, de Caralt TM, Perea RJ, Fernandez-Armenta J, Zeljko H, Brugada J. Integration of 3D electroanatomic maps and magnetic resonance scar characterization into the navigation system to guide ventricular tachycardia ablation. Circ Arrhythm Electrophysiol. 2011 Oct;4(5):674-83. doi: 10.1161/CIRCEP.111.961946. Epub 2011 Aug 31.

  PMID: 21880674 BACKGROUND

• Komatsu Y, Cochet H, Jadidi A, Sacher F, Shah A, Derval N, Scherr D, Pascale P, Roten L, Denis A, Ramoul K, Miyazaki S, Daly M, Riffaud M, Sermesant M, Relan J, Ayache N, Kim S, Montaudon M, Laurent F, Hocini M, Haissaguerre M, Jais P. Regional myocardial wall thinning at multidetector computed tomography correlates to arrhythmogenic substrate in postinfarction ventricular tachycardia: assessment of structural and electrical substrate. Circ Arrhythm Electrophysiol. 2013 Apr;6(2):342-50. doi: 10.1161/CIRCEP.112.000191. Epub 2013 Mar 10.

  PMID: 23476043 BACKGROUND

• Liang JJ, Muser D, Santangeli P. Ventricular Tachycardia Ablation Clinical Trials. Card Electrophysiol Clin. 2017 Mar;9(1):153-165. doi: 10.1016/j.ccep.2016.10.012. Epub 2016 Dec 24.

  PMID: 28167083 BACKGROUND

• Santangeli P, Muser D, Maeda S, Filtz A, Zado ES, Frankel DS, Dixit S, Epstein AE, Callans DJ, Marchlinski FE. Comparative effectiveness of antiarrhythmic drugs and catheter ablation for the prevention of recurrent ventricular tachycardia in patients with implantable cardioverter-defibrillators: A systematic review and meta-analysis of randomized controlled trials. Heart Rhythm. 2016 Jul;13(7):1552-9. doi: 10.1016/j.hrthm.2016.03.004. Epub 2016 Mar 4.

  PMID: 26961297 BACKGROUND

• Liang JJ, Santangeli P, Callans DJ. Long-term Outcomes of Ventricular Tachycardia Ablation in Different Types of Structural Heart Disease. Arrhythm Electrophysiol Rev. 2015 Dec;4(3):177-83. doi: 10.15420/aer.2015.4.3.177. Epub 2015 Dec 1.

  PMID: 26835122 BACKGROUND

• Santangeli P, Muser D, Zado ES, Magnani S, Khetpal S, Hutchinson MD, Supple G, Frankel DS, Garcia FC, Bala R, Riley MP, Lin D, Rame JE, Schaller R, Dixit S, Marchlinski FE, Callans DJ. Acute hemodynamic decompensation during catheter ablation of scar-related ventricular tachycardia: incidence, predictors, and impact on mortality. Circ Arrhythm Electrophysiol. 2015 Feb;8(1):68-75. doi: 10.1161/CIRCEP.114.002155. Epub 2014 Dec 9.

  PMID: 25491601 BACKGROUND

• Santangeli P, Frankel DS, Tung R, Vaseghi M, Sauer WH, Tzou WS, Mathuria N, Nakahara S, Dickfeldt TM, Lakkireddy D, Bunch TJ, Di Biase L, Natale A, Tholakanahalli V, Tedrow UB, Kumar S, Stevenson WG, Della Bella P, Shivkumar K, Marchlinski FE, Callans DJ; International VT Ablation Center Collaborative Group. Early Mortality After Catheter Ablation of Ventricular Tachycardia in Patients With Structural Heart Disease. J Am Coll Cardiol. 2017 May 2;69(17):2105-2115. doi: 10.1016/j.jacc.2017.02.044.

  PMID: 28449770 BACKGROUND

• Tzou WS, Tung R, Frankel DS, Vaseghi M, Bunch TJ, Di Biase L, Tholakanahalli VN, Lakkireddy D, Dickfeld T, Saliaris A, Weiss JP, Mathuria N, Tedrow U, Afzal MR, Vergara P, Nagashima K, Patel M, Nakahara S, Vakil K, Burkhardt JD, Tseng CH, Natale A, Shivkumar K, Callans DJ, Stevenson WG, Della Bella P, Marchlinski FE, Sauer WH. Ventricular Tachycardia Ablation in Severe Heart Failure: An International Ventricular Tachycardia Ablation Center Collaboration Analysis. Circ Arrhythm Electrophysiol. 2017 Jan;10(1):e004494. doi: 10.1161/CIRCEP.116.004494.

  PMID: 28082527 BACKGROUND

• Zghaib T, Ipek EG, Hansford R, Ashikaga H, Berger RD, Marine JE, Spragg DD, Tandri H, Zimmerman SL, Halperin H, Brancato S, Calkins H, Henrikson C, Nazarian S. Standard Ablation Versus Magnetic Resonance Imaging-Guided Ablation in the Treatment of Ventricular Tachycardia. Circ Arrhythm Electrophysiol. 2018 Jan;11(1):e005973. doi: 10.1161/CIRCEP.117.005973. No abstract available.

  PMID: 29330333 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized controlled non-blinded prospective single-center study

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: April 25, 2023
• Study Start: October 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)