Sustained Monomorphic VT (MMVT)FACILE-VTNCT06931821

Functional ElectroAnatomiC Isochronal Late Activation Mapping for Empiric VT Ablation Trial

A study testing Isochronal Late Activation Mapping (ILAM) and High Density Voltage Mapping in people with Sustained Monomorphic VT (MMVT) and Recurrent Ventricular Tachycardia, run by University of Arizona at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Sustained Monomorphic VT (MMVT), Recurrent Ventricular Tachycardia
What is being tested?: Isochronal Late Activation Mapping (ILAM) and High Density Voltage Mapping
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 360 participants
Where: 1 siteUnited States
Study dates: 15 Apr 2025to 30 Apr 2029
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

Subjects who meet any of the following exclusion criteria must be excluded from the clinical investigation:
Active infection (positive blood culture).
Patient is pregnant or nursing.
Cardiac surgery via sternotomy (CABG or valve repair/replacement) within 30 days prior to enrollment.
Contraindication to systemic anticoagulation (i.e., heparin, warfarin, or a direct thrombin inhibitor).
Currently receiving support via extracorporeal membrane oxygenation (ECMO) or ventricular assist device (VAD).

Show all 17Show fewer

Left Ventriclar ejection fraction < 15%.
Stroke within 30 days or presence of LV thrombus within 1 month prior to enrollment.
Idiopathic VT or preprocedural imaging without scar (MRI or CT).
Limited life expectancy of 1 year or less.
Presence of mitral and aortic valves both mechanical.
Ventricular tachycardia secondary to electrolyte imbalance or any other reversible or non-cardiac cause.
Severe aortic stenosis or flail mitral valve with severed mitral regurgitation.
Thrombocytopenia (defined as platelet count <50,000/μl ) or coagulopathy.
Ventricular arrhythmias secondary to underlying channelopathies (LQTS, Brugada Syndrome).
Enrolled in an investigational study evaluating another device or drug that would confound the results of this study.
Other anatomic or co-morbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow up requirement of 1 year, or impact the scientific integrity of the study results.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Priyanka Sharma contact

602-521-3090

priyankasharma1@arizona.edu

Dalise Shatz contact

602-839-4540

daliseshatz@arizona.edu

United States1 site, 1 recruiting

Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
Crystal Gonzalez, MSW, 602-255-7553, crgonzalez4@arizona.edu
Elena Young, 602-255-7553, elenay@arizona.edu
Recruiting

Other trials in United States

About this study

This is a multicenter, prospective, parallel, randomized controlled trial to test for non-inferiority with an ILAM-guided VT ablation compared to conventional voltage- based ablation. The study has two treatment arms: conventional voltage mapping and ablation (control arm). In the investigational arm, the ablation strategy is guided by ILAM to target deceleration zones, blinded to voltage mapping. In the control arm, ablation will be performed to extensively ablate all low voltage regions (<1.5mV) during sinus rhythm, right ventricular (RV) pacing, or left ventricular (LV) pacing, with discretionary use of pacemapping and activation mapping. In both arms, mapping with be performed with a multielectrode catheter (HD Grid) and ablation will be performed using an irrigated tip catheter (FlexAbility SE or Tactiflex catheters).

In the control armonly voltage mapping displays will be utilized (blinded to functional ILAM and fractionation). High density mapping with automated last deflection annotation (Ensite X) will be performed in all patients randomized to ILAM approach during either sinus rhythm or RV pacing.

Conditions: Sustained Monomorphic VT (MMVT), Recurrent Ventricular Tachycardia
Being tested: Isochronal Late Activation Mapping (ILAM), High Density Voltage Mapping
Keywords: Ventricular Tachycardia, Isochronal Late Activation Mapping, high-density mapping, deceleration zone
Medical subject headings: Tachycardia, Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Isochronal Late Activation Mapping (ILAM)Device
an isochronal late activation mapping (ILAM) display with automated last deflection annotation (EnSite X™) will be used to identify regions of isochronal crowding around a line of conduction block for targeted ablation therapy using a standard irrigated tip catheter (Flexability SE \& Tactiflex catheters)
High Density Voltage MappingDevice
high-density voltage mapping will serve as the method to display the electroanatomic substrate for extensive and diffuse ablation within the low voltage area (<1.5 mV).

Study groups in NCT06931821
Study group	Role	What they receive
High Density Voltage Mapping	Active comparator	high-density voltage mapping will serve as the method to display the electroanatomic substrate for extensive and diffuse ablation within the low voltage area (<1.5 mV) Receives: Device: High Density Voltage Mapping
Isochronal Late Activation Mapping (ILAM)	Experimental	an isochronal late activation mapping (ILAM) display with automated last deflection annotation (EnSite X™) will be used to identify regions of isochronal crowding around a line of conduction block for targeted ablation therapy using a standard irrigated tip catheter (Flexability SE \& Tactiflex catheters). Receives: Device: Isochronal Late Activation Mapping (ILAM)

What is being measured

The primary outcome is the main question the study is designed to answer.

Inducibility for VT
Inducibility for VT after initial 25 minutes of ablation (minutes of radiofrequency)
Measured: after initial 25 minutes of ablation (minutes of radiofrequency)
Recurrent VT
recurrent VT at 1 year
Measured: 1 year post procedure
CV Hospitalization
Hospitalization due to Cardiovascular complications related to heart failure or arrhythmia at 1 year
Measured: 1 year post procedure
Mortality
Mortality at 1 year
Measured: 1 year post procedure
Procedure Related Safety
hematoma requiring transfusion, cardiac perforation, stroke, hemorrhage, pericardial effusion
Measured: Duration of Hospitalization (up to 7 days)

Secondary outcomes (7)

Individual assessment of four endpoints comprising the primary endpoint.
Individual assessment of four individual endpoints comprising the primary endpoint.
Measured: 1 year post procedure
Total radiofrequency time delivered and procedural time.
Measured: Duration of Procedure
Reduction in VT burden
Measured: 1 year post procedure
Quality of Life improvement
The overall quality of life will be assessed using the SF-36 instrument, which includes 36 items rated on a 4-point Likert scale. In all nine subscales, lower scores indicate poorer outcomes in various areas, including physical functioning, social limitations due to physical or mental health issues, challenges related to work or daily activities, and feelings of nervousness, depression, fatigue, exhaustion, and pain.
Measured: 1 year post procedure
Procedural complications
tamponade, hematoma requiring transfusion, stroke, emergent surgery
Measured: Duration of Hospitalization (up to 7 days)
Length of stay in hospital from index procedure
Measured: Duration of Hospitalization (up to 7 days)
Rate of Acute Kidney Injury
Number of Participants with acute kidney injury, verified by creatinine checked the day after ablation.
Measured: 1 day post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 202530 Apr 2029

First posted17 Apr 2025
Study start15 Apr 2025
Primary completion30 Apr 2028 (estimated)
Study completion30 Apr 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (28)Papers the sponsor has linked to this study.
Other trials for Sustained Monomorphic VT (MMVT)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: randomized controlled clinical trial with 1:1 randomization to two strategies for ventricular tachycardia (VT) mapping and ablation.
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 360 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06931821
Sponsor's protocol ID: STUDY00003834
Acronym: FACILE-VT
Status last verified: May 2026
First submitted: 1 Apr 2025
Last updated: 27 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL. 2013 ACCF/AHA guideline for the management of heart failure: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013 Oct 15;128(16):1810-52. doi: 10.1161/CIR.0b013e31829e8807. Epub 2013 Jun 5. No abstract available.
PubMed 23741057
Seiler J, Roberts-Thomson KC, Raymond JM, Vest J, Delacretaz E, Stevenson WG. Steam pops during irrigated radiofrequency ablation: feasibility of impedance monitoring for prevention. Heart Rhythm. 2008 Oct;5(10):1411-6. doi: 10.1016/j.hrthm.2008.07.011. Epub 2008 Jul 10.
PubMed 18929327
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.
PubMed 22492578
Jiang R, Beaser AD, Aziz Z, Upadhyay GA, Nayak HM, Tung R. High-Density Grid Catheter for Detailed Mapping of Sinus Rhythm and Scar-Related Ventricular Tachycardia: Comparison With a Linear Duodecapolar Catheter. JACC Clin Electrophysiol. 2020 Mar;6(3):311-323. doi: 10.1016/j.jacep.2019.11.007. Epub 2020 Jan 29.
PubMed 32192682
Raiman M, Tung R. Automated isochronal late activation mapping to identify deceleration zones: Rationale and methodology of a practical electroanatomic mapping approach for ventricular tachycardia ablation. Comput Biol Med. 2018 Nov 1;102:336-340. doi: 10.1016/j.compbiomed.2018.07.012. Epub 2018 Jul 18.
PubMed 30033360
Marcus FI, McKenna WJ, Sherrill D, Basso C, Bauce B, Bluemke DA, Calkins H, Corrado D, Cox MG, Daubert JP, Fontaine G, Gear K, Hauer R, Nava A, Picard MH, Protonotarios N, Saffitz JE, Sanborn DM, Steinberg JS, Tandri H, Thiene G, Towbin JA, Tsatsopoulou A, Wichter T, Zareba W. Diagnosis of arrhythmogenic right ventricular cardiomyopathy/dysplasia: proposed modification of the task force criteria. Circulation. 2010 Apr 6;121(13):1533-41. doi: 10.1161/CIRCULATIONAHA.108.840827. Epub 2010 Feb 19.
PubMed 20172911
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.
PubMed 25740836
Tung R, Josephson ME, Bradfield JS, Shivkumar K. Directional Influences of Ventricular Activation on Myocardial Scar Characterization: Voltage Mapping With Multiple Wavefronts During Ventricular Tachycardia Ablation. Circ Arrhythm Electrophysiol. 2016 Aug;9(8):e004155. doi: 10.1161/CIRCEP.116.004155.
PubMed 27516464
Tung R, Kim S, Yagishita D, Vaseghi M, Ennis DB, Ouadah S, Ajijola OA, Bradfield JS, Mahapatra S, Finn P, Shivkumar K. Scar voltage threshold determination using ex vivo magnetic resonance imaging integration in a porcine infarct model: Influence of interelectrode distances and three-dimensional spatial effects of scar. Heart Rhythm. 2016 Oct;13(10):1993-2002. doi: 10.1016/j.hrthm.2016.07.003. Epub 2016 Jul 5.
PubMed 27392944
Nakahara S, Tung R, Ramirez RJ, Michowitz Y, Vaseghi M, Buch E, Gima J, Wiener I, Mahajan A, Boyle NG, Shivkumar K. Characterization of the arrhythmogenic substrate in ischemic and nonischemic cardiomyopathy implications for catheter ablation of hemodynamically unstable ventricular tachycardia. J Am Coll Cardiol. 2010 May 25;55(21):2355-65. doi: 10.1016/j.jacc.2010.01.041.
PubMed 20488307
Tung R, Nakahara S, Ramirez R, Gui D, Magyar C, Lai C, Fishbein M, Shivkumar K. Accuracy of combined endocardial and epicardial electroanatomic mapping of a reperfused porcine infarct model: a comparison of electrofield and magnetic systems with histopathologic correlation. Heart Rhythm. 2011 Mar;8(3):439-47. doi: 10.1016/j.hrthm.2010.10.044. Epub 2010 Nov 4.
PubMed 21056123
Tung R, Nakahara S, Maccabelli G, Buch E, Wiener I, Boyle NG, Carbucicchio C, Bella PD, Shivkumar K. Ultra high-density multipolar mapping with double ventricular access: a novel technique for ablation of ventricular tachycardia. J Cardiovasc Electrophysiol. 2011 Jan;22(1):49-56. doi: 10.1111/j.1540-8167.2010.01859.x.
PubMed 20653813
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.
PubMed 26031376
Al-Khatib SM, Daubert JP, Anstrom KJ, Daoud EG, Gonzalez M, Saba S, Jackson KP, Reece T, Gu J, Pokorney SD, Granger CB, Hess PL, Mark DB, Stevenson WG. Catheter ablation for ventricular tachycardia in patients with an implantable cardioverter defibrillator (CALYPSO) pilot trial. J Cardiovasc Electrophysiol. 2015 Feb;26(2):151-7. doi: 10.1111/jce.12567. Epub 2014 Nov 30.
PubMed 25332150
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.
PubMed 18160685

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Functional ElectroAnatomiC Isochronal Late Activation Mapping for Empiric VT Ablation Trial
ClinicalTrials.gov ID: NCT06931821
Acronym / sponsor ID: FACILE-VT / STUDY00003834
Conditions: Sustained Monomorphic VT (MMVT), Recurrent Ventricular Tachycardia
Keywords: Ventricular Tachycardia, Isochronal Late Activation Mapping, high-density mapping, deceleration zone
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 360 participants (estimated)
Lead sponsor: University of ArizonaUniversity, hospital or other
Collaborators: Abbott
Study start: 15 Apr 2025 (actual)
Primary completion: 30 Apr 2028 (estimated)
Study completion: 30 Apr 2029 (estimated)
First posted: 17 Apr 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2
Model description: randomized controlled clinical trial with 1:1 randomization to two strategies for ventricular tachycardia (VT) mapping and ablation.

Arm	Type	Receives
High Density Voltage Mapping	Active comparator	Device: High Density Voltage Mappinghigh-density voltage mapping will serve as the method to display the electroanatomic substrate for extensive and diffuse ablation within the low voltage area (<1.5 mV)
Isochronal Late Activation Mapping (ILAM)	Experimental	Device: Isochronal Late Activation Mapping (ILAM)an isochronal late activation mapping (ILAM) display with automated last deflection annotation (EnSite X™) will be used to identify regions of isochronal crowding around a line of conduction block for targeted ablation therapy using a standard irrigated tip catheter (Flexability SE \& Tactiflex catheters).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (17 listed)

Subjects who meet any of the following exclusion criteria must be excluded from the clinical investigation:
Active infection (positive blood culture).
Patient is pregnant or nursing.
Cardiac surgery via sternotomy (CABG or valve repair/replacement) within 30 days prior to enrollment.
Contraindication to systemic anticoagulation (i.e., heparin, warfarin, or a direct thrombin inhibitor).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Isochronal Late Activation Mapping (ILAM)an isochronal late activation mapping (ILAM) display with automated last deflection annotation (EnSite X™) will be used to identify regions of isochronal crowding around a line of conduction block for targeted ablation therapy using a standard irrigated tip catheter (Flexability SE \& Tactiflex catheters)	Device	Isochronal Late Activation Mapping (ILAM)
High Density Voltage Mappinghigh-density voltage mapping will serve as the method to display the electroanatomic substrate for extensive and diffuse ablation within the low voltage area (<1.5 mV).	Device	High Density Voltage Mapping

Primary outcome

Inducibility for VT
Time frame: after initial 25 minutes of ablation (minutes of radiofrequency)
Inducibility for VT after initial 25 minutes of ablation (minutes of radiofrequency)
Recurrent VT
Time frame: 1 year post procedure
recurrent VT at 1 year
CV Hospitalization
Time frame: 1 year post procedure
Hospitalization due to Cardiovascular complications related to heart failure or arrhythmia at 1 year
Mortality
Time frame: 1 year post procedure
Mortality at 1 year
Procedure Related Safety
Time frame: Duration of Hospitalization (up to 7 days)
hematoma requiring transfusion, cardiac perforation, stroke, hemorrhage, pericardial effusion

7 secondary outcomes

Individual assessment of four endpoints comprising the primary endpoint.
Time frame: 1 year post procedure
Total radiofrequency time delivered and procedural time.
Time frame: Duration of Procedure
Reduction in VT burden
Time frame: 1 year post procedure
Quality of Life improvement
Time frame: 1 year post procedure
Procedural complications
Time frame: Duration of Hospitalization (up to 7 days)
Length of stay in hospital from index procedure
Time frame: Duration of Hospitalization (up to 7 days)
Rate of Acute Kidney Injury
Time frame: 1 day post procedure

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
Background: PubMed 23741057Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL. 2013 ACCF/AHA guideline for the management of heart failure: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013 Oct 15;128(16):1810-52. doi: 10.1161/CIR.0b013e31829e8807. Epub 2013 Jun 5. No abstract available.
Background: PubMed 18929327Seiler J, Roberts-Thomson KC, Raymond JM, Vest J, Delacretaz E, Stevenson WG. Steam pops during irrigated radiofrequency ablation: feasibility of impedance monitoring for prevention. Heart Rhythm. 2008 Oct;5(10):1411-6. doi: 10.1016/j.hrthm.2008.07.011. Epub 2008 Jul 10.
Background: PubMed 22492578Jais 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.
Background: PubMed 32192682Jiang R, Beaser AD, Aziz Z, Upadhyay GA, Nayak HM, Tung R. High-Density Grid Catheter for Detailed Mapping of Sinus Rhythm and Scar-Related Ventricular Tachycardia: Comparison With a Linear Duodecapolar Catheter. JACC Clin Electrophysiol. 2020 Mar;6(3):311-323. doi: 10.1016/j.jacep.2019.11.007. Epub 2020 Jan 29.
Background: PubMed 30033360Raiman M, Tung R. Automated isochronal late activation mapping to identify deceleration zones: Rationale and methodology of a practical electroanatomic mapping approach for ventricular tachycardia ablation. Comput Biol Med. 2018 Nov 1;102:336-340. doi: 10.1016/j.compbiomed.2018.07.012. Epub 2018 Jul 18.
Background: PubMed 20172911Marcus FI, McKenna WJ, Sherrill D, Basso C, Bauce B, Bluemke DA, Calkins H, Corrado D, Cox MG, Daubert JP, Fontaine G, Gear K, Hauer R, Nava A, Picard MH, Protonotarios N, Saffitz JE, Sanborn DM, Steinberg JS, Tandri H, Thiene G, Towbin JA, Tsatsopoulou A, Wichter T, Zareba W. Diagnosis of arrhythmogenic right ventricular cardiomyopathy/dysplasia: proposed modification of the task force criteria. Circulation. 2010 Apr 6;121(13):1533-41. doi: 10.1161/CIRCULATIONAHA.108.840827. Epub 2010 Feb 19.
Background: PubMed 25740836Irie 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.
Background: PubMed 27516464Tung R, Josephson ME, Bradfield JS, Shivkumar K. Directional Influences of Ventricular Activation on Myocardial Scar Characterization: Voltage Mapping With Multiple Wavefronts During Ventricular Tachycardia Ablation. Circ Arrhythm Electrophysiol. 2016 Aug;9(8):e004155. doi: 10.1161/CIRCEP.116.004155.
Background: PubMed 27392944Tung R, Kim S, Yagishita D, Vaseghi M, Ennis DB, Ouadah S, Ajijola OA, Bradfield JS, Mahapatra S, Finn P, Shivkumar K. Scar voltage threshold determination using ex vivo magnetic resonance imaging integration in a porcine infarct model: Influence of interelectrode distances and three-dimensional spatial effects of scar. Heart Rhythm. 2016 Oct;13(10):1993-2002. doi: 10.1016/j.hrthm.2016.07.003. Epub 2016 Jul 5.
Background: PubMed 20488307Nakahara S, Tung R, Ramirez RJ, Michowitz Y, Vaseghi M, Buch E, Gima J, Wiener I, Mahajan A, Boyle NG, Shivkumar K. Characterization of the arrhythmogenic substrate in ischemic and nonischemic cardiomyopathy implications for catheter ablation of hemodynamically unstable ventricular tachycardia. J Am Coll Cardiol. 2010 May 25;55(21):2355-65. doi: 10.1016/j.jacc.2010.01.041.
Background: PubMed 21056123Tung R, Nakahara S, Ramirez R, Gui D, Magyar C, Lai C, Fishbein M, Shivkumar K. Accuracy of combined endocardial and epicardial electroanatomic mapping of a reperfused porcine infarct model: a comparison of electrofield and magnetic systems with histopathologic correlation. Heart Rhythm. 2011 Mar;8(3):439-47. doi: 10.1016/j.hrthm.2010.10.044. Epub 2010 Nov 4.
Background: PubMed 20653813Tung R, Nakahara S, Maccabelli G, Buch E, Wiener I, Boyle NG, Carbucicchio C, Bella PD, Shivkumar K. Ultra high-density multipolar mapping with double ventricular access: a novel technique for ablation of ventricular tachycardia. J Cardiovasc Electrophysiol. 2011 Jan;22(1):49-56. doi: 10.1111/j.1540-8167.2010.01859.x.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Priyanka Sharma contact

602-521-3090

priyankasharma1@arizona.edu

Dalise Shatz contact

602-839-4540

daliseshatz@arizona.edu

Roderick Tung, MD principal investigator

University of Arizona

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Priyanka Sharma (602-521-3090, priyankasharma1@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inducibility for VT (time frame: after initial 25 minutes of ablation (minutes of radiofrequency)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06931821, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.