Ventricular TachycardiaAIM-VTNCT06138873
Ablation-Index Guided Scar-Mediated Ventricular Tachycardia Ablation in Patients With Ischemic Cardiomyopathy
A study testing Ablation-index guided ventricular tachycardia ablation and Ventricular tachycardia ablation with no AI-guidance in people with Ventricular Tachycardia and Ischemic Cardiomyopathy, run by Rush University Medical Center at 5 sites in United States.
Trial summary
Over the last decade, radiofrequency catheter ablation (RFCA) has become an established treatment for ventricular arrhythmias (VA). Due to the challenging nature of visualizing lesion formation in real time and ensuring an effective transmural lesion, different surrogate measures of lesion quality have been used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Ischemic Cardiomyopathy
- What is being tested?
- Ablation-index guided ventricular tachycardia ablation and Ventricular tachycardia ablation with no AI-guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- 23 Oct 2024to 23 Nov 2027
- 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
- Patient ≥ 18 y.o.
- Structural Heart Disease: Ischemic Cardiomyopathy
- Sustained Scar-related Monomorphic Ventricular Tachycardia documented by ECG or CIED interrogation
Who cannot join
- If clinical ventricular arrhythmia is predominantly PVCs, supraventricular tachycardia, or ventricular fibrillation
- Myocardial infarction or cardiac surgery within 6 months
- Severe mitral regurgitation
- Stroke or TIA within 6 months
- Prior VT substrate ablation in the previous 6 months
- NYHA functional class IV
- Non-ischemic VT substrate
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Not yet recruiting
Medical University of Michigan
Ann Arbor, Michigan, 48109
Jackson Liang, DO, 888-287-1082, liangjac@med.umich.edu
Jackson Liang, DO
- Not yet recruiting
Mass General Brigham and Women's Hospital
Boston, Massachusetts, 02115
Jorge E. Romero, MD, 617-732-5241, jeromero@bwh.harvard.edu
Obadah Aloum, 617-732-5241, OALOUM@BWH.HARVARD.EDU
- Not yet recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Bishnu Dhakal, MD, 843-876-2700, dhakalb@musc.edu
Chandler Schwede, 843-792-5998, schwede@musc.edu
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60614
Henry D Huang, MD, 312-942-5020, henry_d_huang@rush.edu
- Not yet recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Konstantinos Siontis, MD, 507-422-0549, Siontis.Konstantinos@mayo.edu
Konstantinos Siontis, MD
About this study
Official title: Ablation-Index Guided Scar-Mediated Ventricular Tachycardia Ablation in Patients With Ischemic Cardiomyopathy (AIM-VT) - a Prospective Single-Blinded, Multicenter Randomized Controlled Trial
Over the last decade, radiofrequency catheter ablation (RFCA) has become an established treatment for ventricular arrhythmias (VA). Due to the challenging nature of visualizing lesion formation in real time and ensuring an effective transmural lesion, different surrogate measures of lesion quality have been used. The Ablation Index (AI) is a variable incorporating power delivery in its formula and combining it with CF and time in a weighted equation which aims at allowing for a more precise estimation of lesion depth and quality when ablating VAs. AI guidance has previously been shown to improve outcomes in atrial and ventricular ablation in patients with premature ventricular complexes (PVC). However research on outcomes following AI-guidance for VT ablation specifically in patients with structural disease and prior myocardial infarction remains sparse. The investigators aim at conducting the first randomized controlled trial testing for the superiority of an AI-guided approach regarding procedural duration.
Read the detailed description
Over the last decade, radiofrequency catheter ablation (RFCA) has become an established treatment for ventricular arrhythmias (VA). RFCA uses electromagnetic energy that transforms into heat upon delivery into the myocardium and irreversibly damages the viable myocytes, causing the loss of cellular excitability. Irreversible loss of cellular excitability generally occurs at temperatures exceeding 50°C, while at lower temperatures, the damage is not permanent and myocytes can recover excitability, leading to VA recurrences. Due to the challenging nature of visualizing lesion formation in real time and ensuring an effective transmural lesion, different surrogate measures of lesion quality have been used. The fall in local impedance during ablation has been considered as a first marker of the direct effect of ablation in cardiac tissue but the generator impedance drop does not correlate well with lesion size. First, large impedance drops can indicate impeding steam pop without effective lesion formation. Second scar tissue carries a lower impedance than healthy tissue due to their higher water/collagen content and make impedance drops less reliable.
One of the major determinants of lesion formation is an adequate contact between the tip of the catheter and the myocardial surface. A first major technological advancement in ablation catheters was the development of sensors at the distal tip capable of monitoring contact (contact force, CF). A recent ablation marker is the Force-Time-Integral (FTI), which multiplies CF by radiofrequency application duration. Limitations in this ablation parameter are the exclusion of maximal power settings being delivered and the assumption that a single target FTI is required in all myocardial segments with varying wall thickness and underlying substrate. Also for prolonged energy deliveries, the contribution of radiofrequency application duration is proportionally less important in lesion creation than CF. To overcome some of these limitations, the Ablation Index (AI) was introduced. This is a variable incorporating power delivery in its formula and combining it with CF and time in a weighted equation. It has shown to be a more precise estimation of lesion depth and quality in animal models and humans than FTI, time alone or impedance drop.
AI guidance has previously been shown to improve outcomes in atrial and ventricular ablation in patients with premature ventricular complexes (PVC). However research on outcomes following AI-guidance for VT ablation specifically in patients with structural disease and prior myocardial infarction remains sparse, with mainly research conducted in ex-vivo porcine or canine models. In theory, use of AI to guide ablation in this subpopulation of VT patients may shorten procedure time and possibly improve procedural safety in comparison to ablation guided by less reliable conventional parameters or fixed energy application durations. First pilot studies assessing AI-guided VT ablations in patients with structural heart disease provided some observational insights on procedural parameters but our study is the first randomized controlled trial testing for the superiority of an AI-guided approach regarding procedural duration.
- Conditions
- Ventricular Tachycardia, Ischemic Cardiomyopathy
- Being tested
- Ablation-index guided ventricular tachycardia ablation, Ventricular tachycardia ablation with no AI-guidance
- Keywords
- ventricular, tachycardia, ablation index, ischemic cardiomyopathy
- Medical subject headings
- Tachycardia, Ventricular, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation-index guided ventricular tachycardia ablationProcedure or surgery
As described in arms descriptions
Ventricular tachycardia ablation with no AI-guidanceProcedure or surgery
As described in arms descriptions
| Study group | Role | What they receive |
|---|---|---|
| AI-guided ablation | Experimental | Use of AI guidance to conduct the ablation Receives: Procedure: Ablation-index guided ventricular tachycardia ablation |
| non-AI guided ablation | Active comparator | Ablation without AI guidance, AI values masked to the operator. Receives: Procedure: Ventricular tachycardia ablation with no AI-guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage reduction in ablation time between the groups with/without AI guidance
Percentage of reduction in ablation time in seconds, with ablation time defined as the total radiofrequency delivery time delivered during the VT ablation procedure. Total ablation time is automatically recorded by the Carto System Software and will be subsequently extracted as part of a raw unedited data file for unbiased endpoint evaluation.
Measured: intra-procedural
Secondary outcomes (3)
Percentage of reduction in total procedural duration in seconds between the AI/not AI group
the time elapsed from injection of lidocaine as the start and removal of all catheters from the heart as the end of the procedure. Timestamps logged for these events in the EP lab will be used for unbiased endpoint evaluation.
Measured: intra-procedural
Total intravenous fluids administered in milliliters (ml)
Defined as total intravenous fluid volume administered in the EP laboratory
Measured: intra-procedural
Fluoroscopy duration in minutes
The time elapsed of procedural fluoroscopy usage in minutes
Measured: intra-procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start23 Oct 2024
- Primary completion23 Nov 2026 (estimated)
- Study completion23 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Medical University of South Carolina, Biosense Webster, Inc., Mayo Clinic, Brigham and Women's Hospital
- Responsible party
- Sponsor
- Investigators
- Alexander Mazur, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138873
- Sponsor's protocol ID
- AIM-VT
- Acronym
- AIM-VT
- Status last verified
- Sep 2025
- First submitted
- 10 Nov 2023
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Proietti R, Lichelli L, Lellouche N, Dhanjal T. The challenge of optimising ablation lesions in catheter ablation of ventricular tachycardia. J Arrhythm. 2020 Dec 28;37(1):140-147. doi: 10.1002/joa3.12489. eCollection 2021 Feb.
PubMed 33664896Larsen T, Du-Fay-de-Lavallaz JM, Winterfield JR, Ravi V, Rhodes P, Wasserlauf J, Trohman RG, Sharma PS, Huang HD. Comparison of ablation index versus time-guided radiofrequency energy dosing using normal and half-normal saline irrigation in a porcine left ventricular model. J Cardiovasc Electrophysiol. 2022 Apr;33(4):698-712. doi: 10.1111/jce.15379. Epub 2022 Jan 30.
PubMed 35048448Hussein A, Das M, Riva S, Morgan M, Ronayne C, Sahni A, Shaw M, Todd D, Hall M, Modi S, Natale A, Dello Russo A, Snowdon R, Gupta D. Use of Ablation Index-Guided Ablation Results in High Rates of Durable Pulmonary Vein Isolation and Freedom From Arrhythmia in Persistent Atrial Fibrillation Patients: The PRAISE Study Results. Circ Arrhythm Electrophysiol. 2018 Sep;11(9):e006576. doi: 10.1161/CIRCEP.118.006576.
PubMed 30354288Gasperetti A, Sicuso R, Dello Russo A, Zucchelli G, Saguner AM, Notarstefano P, Soldati E, Bongiorni MG, Della Rocca DG, Mohanty S, Carbucicchio C, Duru F, Di Biase L, Natale A, Tondo C, Casella M. Prospective use of ablation index for the ablation of right ventricle outflow tract premature ventricular contractions: a proof of concept study. Europace. 2021 Jan 27;23(1):91-98. doi: 10.1093/europace/euaa228.
PubMed 33063099Bates AP, Paisey J, Yue A, Banks P, Roberts PR, Ullah W. Radiofrequency Ablation of the Diseased Human Left Ventricle: Biophysical and Electrogram-Based Analysis. JACC Clin Electrophysiol. 2023 Mar;9(3):330-340. doi: 10.1016/j.jacep.2022.10.001. Epub 2022 Oct 10.
PubMed 36371330
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation-Index Guided Scar-Mediated Ventricular Tachycardia Ablation in Patients With Ischemic Cardiomyopathy (AIM-VT) - a Prospective Single-Blinded, Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06138873
- Acronym / sponsor ID
- AIM-VT / AIM-VT
- Conditions
- Ventricular Tachycardia, Ischemic Cardiomyopathy
- Keywords
- ventricular, tachycardia, ablation index, ischemic cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- University of Michigan, Medical University of South Carolina, Biosense Webster, Inc., Mayo Clinic, Brigham and Women's Hospital
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 23 Nov 2026 (estimated)
- Study completion
- 23 Nov 2027 (estimated)
- First posted
- 18 Nov 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.
Over the last decade, radiofrequency catheter ablation (RFCA) has become an established treatment for ventricular arrhythmias (VA). Due to the challenging nature of visualizing lesion formation in real time and ensuring an effective transmural lesion, different surrogate measures of lesion quality have been used. The Ablation Index (AI) is a variable incorporating power delivery in its formula and combining it with CF and time in a weighted equation which aims at allowing for a more precise estimation of lesion depth and quality when ablating VAs. AI guidance has previously been shown to improve outcomes in atrial and ventricular ablation in patients with premature ventricular complexes (PVC). However research on outcomes following AI-guidance for VT ablation specifically in patients with structural disease and prior myocardial infarction remains sparse. The investigators aim at conducting the first randomized controlled trial testing for the superiority of an AI-guided approach regarding procedural duration.
Detailed description
Over the last decade, radiofrequency catheter ablation (RFCA) has become an established treatment for ventricular arrhythmias (VA). RFCA uses electromagnetic energy that transforms into heat upon delivery into the myocardium and irreversibly damages the viable myocytes, causing the loss of cellular excitability. Irreversible loss of cellular excitability generally occurs at temperatures exceeding 50°C, while at lower temperatures, the damage is not permanent and myocytes can recover excitability, leading to VA recurrences. Due to the challenging nature of visualizing lesion formation in real time and ensuring an effective transmural lesion, different surrogate measures of lesion quality have been used. The fall in local impedance during ablation has been considered as a first marker of the direct effect of ablation in cardiac tissue but the generator impedance drop does not correlate well with lesion size. First, large impedance drops can indicate impeding steam pop without effective lesion formation. Second scar tissue carries a lower impedance than healthy tissue due to their higher water/collagen content and make impedance drops less reliable.
One of the major determinants of lesion formation is an adequate contact between the tip of the catheter and the myocardial surface. A first major technological advancement in ablation catheters was the development of sensors at the distal tip capable of monitoring contact (contact force, CF). A recent ablation marker is the Force-Time-Integral (FTI), which multiplies CF by radiofrequency application duration. Limitations in this ablation parameter are the exclusion of maximal power settings being delivered and the assumption that a single target FTI is required in all myocardial segments with varying wall thickness and underlying substrate. Also for prolonged energy deliveries, the contribution of radiofrequency application duration is proportionally less important in lesion creation than CF. To overcome some of these limitations, the Ablation Index (AI) was introduced. This is a variable incorporating power delivery in its formula and combining it with CF and time in a weighted equation. It has shown to be a more precise estimation of lesion depth and quality in animal models and humans than FTI, time alone or impedance drop.
AI guidance has previously been shown to improve outcomes in atrial and ventricular ablation in patients with premature ventricular complexes (PVC). However research on outcomes following AI-guidance for VT ablation specifically in patients with structural disease and prior myocardial infarction remains sparse, with mainly research conducted in ex-vivo porcine or canine models. In theory, use of AI to guide ablation in this subpopulation of VT patients may shorten procedure time and possibly improve procedural safety in comparison to ablation guided by less reliable conventional parameters or fixed energy application durations. First pilot studies assessing AI-guided VT ablations in patients with structural heart disease provided some observational insights on procedural parameters but our study is the first randomized controlled trial testing for the superiority of an AI-guided approach regarding procedural duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-guided ablation | Experimental | Procedure: Ablation-index guided ventricular tachycardia ablationUse of AI guidance to conduct the ablation |
| non-AI guided ablation | Active comparator | Procedure: Ventricular tachycardia ablation with no AI-guidanceAblation without AI guidance, AI values masked to the operator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient ≥ 18 y.o.
- Structural Heart Disease: Ischemic Cardiomyopathy
- Sustained Scar-related Monomorphic Ventricular Tachycardia documented by ECG or CIED interrogation
Key exclusion criteria (7 listed)
- If clinical ventricular arrhythmia is predominantly PVCs, supraventricular tachycardia, or ventricular fibrillation
- Myocardial infarction or cardiac surgery within 6 months
- Severe mitral regurgitation
- Stroke or TIA within 6 months
- Prior VT substrate ablation in the previous 6 months
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 |
|---|---|---|
| Ablation-index guided ventricular tachycardia ablationAs described in arms descriptions | Procedure or surgery | AI-guided ablation |
| Ventricular tachycardia ablation with no AI-guidanceAs described in arms descriptions | Procedure or surgery | non-AI guided ablation |
Primary outcome
Percentage reduction in ablation time between the groups with/without AI guidance
Time frame: intra-procedural
Percentage of reduction in ablation time in seconds, with ablation time defined as the total radiofrequency delivery time delivered during the VT ablation procedure. Total ablation time is automatically recorded by the Carto System Software and will be subsequently extracted as part of a raw unedited data file for unbiased endpoint evaluation.
3 secondary outcomes
Percentage of reduction in total procedural duration in seconds between the AI/not AI group
Time frame: intra-procedural
Total intravenous fluids administered in milliliters (ml)
Time frame: intra-procedural
Fluoroscopy duration in minutes
Time frame: intra-procedural
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 22 Sep 2025.
- Background: PubMed 33664896Proietti R, Lichelli L, Lellouche N, Dhanjal T. The challenge of optimising ablation lesions in catheter ablation of ventricular tachycardia. J Arrhythm. 2020 Dec 28;37(1):140-147. doi: 10.1002/joa3.12489. eCollection 2021 Feb.
- Background: PubMed 35048448Larsen T, Du-Fay-de-Lavallaz JM, Winterfield JR, Ravi V, Rhodes P, Wasserlauf J, Trohman RG, Sharma PS, Huang HD. Comparison of ablation index versus time-guided radiofrequency energy dosing using normal and half-normal saline irrigation in a porcine left ventricular model. J Cardiovasc Electrophysiol. 2022 Apr;33(4):698-712. doi: 10.1111/jce.15379. Epub 2022 Jan 30.
- Background: PubMed 30354288Hussein A, Das M, Riva S, Morgan M, Ronayne C, Sahni A, Shaw M, Todd D, Hall M, Modi S, Natale A, Dello Russo A, Snowdon R, Gupta D. Use of Ablation Index-Guided Ablation Results in High Rates of Durable Pulmonary Vein Isolation and Freedom From Arrhythmia in Persistent Atrial Fibrillation Patients: The PRAISE Study Results. Circ Arrhythm Electrophysiol. 2018 Sep;11(9):e006576. doi: 10.1161/CIRCEP.118.006576.
- Background: PubMed 33063099Gasperetti A, Sicuso R, Dello Russo A, Zucchelli G, Saguner AM, Notarstefano P, Soldati E, Bongiorni MG, Della Rocca DG, Mohanty S, Carbucicchio C, Duru F, Di Biase L, Natale A, Tondo C, Casella M. Prospective use of ablation index for the ablation of right ventricle outflow tract premature ventricular contractions: a proof of concept study. Europace. 2021 Jan 27;23(1):91-98. doi: 10.1093/europace/euaa228.
- Background: PubMed 36371330Bates AP, Paisey J, Yue A, Banks P, Roberts PR, Ullah W. Radiofrequency Ablation of the Diseased Human Left Ventricle: Biophysical and Electrogram-Based Analysis. JACC Clin Electrophysiol. 2023 Mar;9(3):330-340. doi: 10.1016/j.jacep.2022.10.001. Epub 2022 Oct 10.
- 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.
Alexander Mazur, MD principal investigator
Rush University Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation-index guided ventricular tachycardia ablation and Ventricular tachycardia ablation with no AI-guidance in people with Ventricular Tachycardia and Ischemic Cardiomyopathy, run by Rush University Medical Center at 5 sites in United States.
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 7 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 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Alexander Mazur, MD (312-942-5020, alexander_mazur@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage reduction in ablation time between the groups with/without AI guidance (time frame: intra-procedural). 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 NCT06138873, which also lists 5 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 22 Sep 2025.