Cardiovascular DiseasesSTABLE-VTNCT05828667

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

A study testing Incorporation of CT and/or c-MRI derived myocardial scar with 3D electroanatomical mapping (EAM). in people with Cardiovascular Diseases, run by University of Pennsylvania at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for: Cardiovascular Diseases
What is being tested?: Incorporation of CT and/or c-MRI derived myocardial scar with 3D electroanatomical mapping (EAM).
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2023to 1 Mar 2024
Phase: Interventional
Are there results?: None posted in the registry

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 to 90 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Hospital of The University Of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: The STandard Versus ImAging SuBstrate Aided Ablation in Severe Left VEntricular

Read the detailed description

The STABLE-VT trial aims to integrate myocardial scar as visualized on cardiac magnetic resonance (c-MRI) or CT into electroanatomical mapping (EAM) for VT ablation. Particularly, we will compare the procedural safety, and acute and long-term clinical efficacy of this imaging-aided VT ablation protocol to standard of care.

Our hypothesis is that patients with ventricular tachycardia (VT) and severe LV dysfunction randomized to this imaging-aided protocol will have shorter procedure duration, improved procedural hemodynamic stability, fewer acute major adverse cardiovascular events (MACE), less need for mechanical support, comparable freedom from VT at noninvasive programmed stimulation (NIPS) sub-acutely after the procedure, and at two-year follow-up compared to standard ablation approach. Herein, our outcomes of interest will be captured during the two years following as part of regular standard of care follow-ups.

Conditions: Cardiovascular Diseases
Being tested: Incorporation of CT and/or c-MRI derived myocardial scar with 3D electroanatomical mapping (EAM).
Medical subject headings: Cardiovascular Diseases

What participants receive

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

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.

Study groups in NCT05828667
Study group	Role	What they receive
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. Receives: Other: Incorporation of CT and/or c-MRI derived myocardial scar with 3D electroanatomical mapping (EAM).

What is being measured

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

Major adverse cardiovascular events (MACE)
Incidence of major adverse cardiac events, which are cardiovascular death, myocardial infarction, stroke/TIA
Measured: 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
Measured: During the procedure, 24-48 hours after the ablation procedure
Number of Participants Requiring Inotropic support use
Incidence of inotropic and vasoactive agents use
Measured: 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
Measured: 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)
Measured: During procedure, up to 24-48 hours after the ablation procedure
Number of Participants Requiring intubation
Need for intubation
Measured: During procedure, 24 hours after the ablation procedure

Secondary outcomes (9)

Experimental procedural duration
Experimental procedural duration
Measured: During procedure
noninvasive programmed stimulation (NIPS) sub-acutely after the procedure
comparable freedom from VT at noninvasive programmed stimulation (NIPS) sub-acutely after the procedure and at two-year follow-up.
Measured: 24-48 hours after the procedure.
Mean and peak procedural lactate level
Mean and peak procedural lactate level
Measured: During procedure
Cumulative procedural inotropic support use
Cumulative procedural inotropic support use
Measured: During procedure, 24-48 hours after the ablation procedure
Hospital stay length following the procedure
Hospital stay length following the procedure
Measured: Periprocedural hospital stay length, up to 2 weeks
Time to ventricular tachycardia (VT)
Time to recurrent VT or censoring at 1 year (detection 10 bpm < rate of slowest VT)
Measured: 1 year
Antiarrhythmic Drugs requirement
Antiarrhythmic Drugs requirement following the procedure
Measured: Through study completion, an average of 1 year
Left ventricular ejection fraction (LVEF)
Change in LVEF at 6 months at regular clinic follow-ups following the procedure
Measured: 6 months after the study
Left ventricular end-diastolic volume (EDV)
Change in EDV at 6 months at regular clinic follow-ups following the procedure
Measured: 6 months after the study

Timeline

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

1 Oct 20231 Mar 2024

First posted25 Apr 2023
Study start1 Oct 2023
Primary completion1 Mar 2024
Study completion1 Mar 2024

Why it stopped: Potential protocol modifications are pending, and enrollment has been challenging.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
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: A randomized controlled non-blinded prospective single-center study
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05828667
Sponsor's protocol ID: 851281
Acronym: STABLE-VT
Status last verified: May 2025
First submitted: 6 Mar 2023
Last updated: 20 May 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 19324259
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.
PubMed 20864488
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.
PubMed 21880674
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.
PubMed 23476043
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.
PubMed 28167083
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.
PubMed 26961297
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.
PubMed 26835122
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.
PubMed 25491601
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.
PubMed 28449770
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.
PubMed 28082527
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.
PubMed 29330333

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The STandard Versus ImAging SuBstrate Aided Ablation in Severe Left VEntricular
ClinicalTrials.gov ID: NCT05828667
Acronym / sponsor ID: STABLE-VT / 851281
Conditions: Cardiovascular Diseases
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Potential protocol modifications are pending, and enrollment has been challenging.
Enrolment: 0 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Study start: 1 Oct 2023 (actual)
Primary completion: 1 Mar 2024 (actual)
Study completion: 1 Mar 2024 (actual)
First posted: 25 Apr 2023 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: A randomized controlled non-blinded prospective single-center study

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

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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.

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

Primary outcome

Major adverse cardiovascular events (MACE)
Time frame: during hospital stay following ablation procedure, up to 1 week
Incidence of major adverse cardiac events, which are cardiovascular death, myocardial infarction, stroke/TIA
Number of Participants Requiring Mechanical circulatory support use
Time frame: During the procedure, 24-48 hours after the ablation procedure
Incidence of mechanical circulatory support (e.g., extra corporeal membrane oxygenation, Impella, LVAD or transplant) use
Number of Participants Requiring Inotropic support use
Time frame: During the procedure, 24-48 hours after the ablation procedure
Incidence of inotropic and vasoactive agents use
Number of Participants With Clinically Significant Pericardial Effusion
Time frame: During the procedure, up to 24 hours after the ablation procedure
Assessing clinically significant pericardial effusion causing hemodynamic instability
Number of Participants With Acute kidney injury
Time frame: During procedure, up to 24-48 hours after the ablation procedure
Acute kidney injury (≥50% within 48 hours of the start of the procedure)
Number of Participants Requiring intubation
Time frame: During procedure, 24 hours after the ablation procedure
Need for intubation

9 secondary outcomes

Experimental procedural duration
Time frame: During procedure
noninvasive programmed stimulation (NIPS) sub-acutely after the procedure
Time frame: 24-48 hours after the procedure.
Mean and peak procedural lactate level
Time frame: During procedure
Cumulative procedural inotropic support use
Time frame: During procedure, 24-48 hours after the ablation procedure
Hospital stay length following the procedure
Time frame: Periprocedural hospital stay length, up to 2 weeks
Time to ventricular tachycardia (VT)
Time frame: 1 year
Antiarrhythmic Drugs requirement
Time frame: Through study completion, an average of 1 year
Left ventricular ejection fraction (LVEF)
Time frame: 6 months after the study
Left ventricular end-diastolic volume (EDV)
Time frame: 6 months after the study

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
Background: PubMed 19324259Bogun 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.
Background: PubMed 20864488Wijnmaalen 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.
Background: PubMed 21880674Andreu 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.
Background: PubMed 23476043Komatsu 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.
Background: PubMed 28167083Liang 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.
Background: PubMed 26961297Santangeli 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.
Background: PubMed 26835122Liang 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.
Background: PubMed 25491601Santangeli 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.
Background: PubMed 28449770Santangeli 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.
Background: PubMed 28082527Tzou 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.
Background: PubMed 29330333Zghaib 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.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 20 May 2025. 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?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major adverse cardiovascular events (MACE) (time frame: during hospital stay following ablation procedure, up to 1 week). The study lists 6 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 NCT05828667, which also lists 11 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 20 May 2025.