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NCT Number: NCT06138873

Ablation-Index Guided Scar-Mediated Ventricular Tachycardia Ablation in Patients With Ischemic Cardiomyopathy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient ≥ 18 y.o.
  • Structural Heart Disease: Ischemic Cardiomyopathy
  • Sustained Scar-related Monomorphic Ventricular Tachycardia documented by ECG or CIED interrogation

Exclusion criteria

  • 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

Treatment and study plan

Ablation-index guided ventricular tachycardia ablation

Procedure

As described in arms descriptions

Ventricular tachycardia ablation with no AI-guidance

Procedure

As described in arms descriptions

Primary outcomes

  1. 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.

Secondary outcomes

  1. Percentage of reduction in total procedural duration in seconds between the AI/not AI group

    Time frame: intra-procedural

    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.

  2. Total intravenous fluids administered in milliliters (ml)

    Time frame: intra-procedural

    Defined as total intravenous fluid volume administered in the EP laboratory

  3. Fluoroscopy duration in minutes

    Time frame: intra-procedural

    The time elapsed of procedural fluoroscopy usage in minutes

Other outcomes

  1. Acute procedural success (no inducible VT), partial success (only non-clinical VT induced), and inducibility not tested at end of procedure (in number, % and risk-difference)

    Time frame: intra-procedural

    The acute procedural success will be defined as the absence of inducible ventricular tachycardia upon completion of the procedure, during further electrophysiologic testing in the EP laboratory. Partial success will be defined by the presence of residual non-clinical VTs, meaning inducible VTs which are not morphologically corresponding to the ones causing the patient's symptoms. Patients for whom the inducibility was not tested at the end of the procedure will be classified in a third category. The number of patients in each of the three categories and the proportion of each category, in percentage, to the whole cohort, will be assessed.

  2. Average ablation time per lesion (in seconds and percentage difference)

    Time frame: intra-procedural

    The ablation time for each patient will be indexed by the number of lesions applied to the myocardium. This ablation/time per lesion will be averaged over all patients using the correct summary measure depending on data distribution (normal or non-normal distributed data) and will be compared between arms.

  3. Number of RF lesions per patient (number, mean with standard deviation/median with interquartile range and percentage difference)

    Time frame: intra-procedural

    The number of radiofrequency application per patient during the ablation will be averaged over all patients using the correct summary measure depending on data distribution (normal or non-normal distributed data) and will be compared between arms.

  4. Ablation Index per lesion (absolute value and percentage difference)

    Time frame: intra-procedural

    The value of the ablation index for each lesion will be summarized in each arm, for the overall patient collective in that arm, using the correct summary measure depending on data distribution (normal or non-normal distributed data) and will be compared between arms.

  5. Steam pops (in number, percentage and risk-difference)

    Time frame: intra-procedural

    The number of steam pops (defined as an audible sound and/or a sudden spike in impedance produced by intramyocardial explosion when tissue temperatures reaches 100°C and leads to gas production) will be counted in each arm and compared between arms using the correct summary measure depending on data distribution (normal or non-normal distributed data).

  6. Impedance drop per lesion (in Ohm and percentage difference)

    Time frame: intra-procedural

    The impedance drop per lesion can be measured using intra-cardiac catheters while applying the lesions. The impedance drop will be averaged over all lesions per patient and per arm and will be compared using the correct summary measure depending on data distribution (normal or non-normal distributed data) and will be compared between arms.

  7. Recurrence event of sustained ventricular tachycardia or ICD therapy within 1 year (in number, % and risk-difference)

    Time frame: 1 year

    Composite outcome of sustained ventricular tachycardia (episode lasting > 30 seconds detected by ICD) or ventricular tachycardia episode treated successfully by ICD therapy (Including ventricular tachycardia episodes terminated by ATP or ICD shock in < 30 seconds based programmed detection/treatment ICD settings).

  8. Complications within 7 days of ventricular tachycardia ablation procedure (in number, % and risk-difference, for the overall combined safety outcome and broken down for each complication)

    Time frame: 7 days post-intervention

    Complications include but are not limited to bleeding, death, pericardial effusion, cardiac tamponade, stroke, arterial thromboembolism, steam pops, thrombus formation, cardiogenic shock, phrenic nerve paralysis, admission for congestive heart failure

  9. Overall hospitalizations after the procedure over 1 year (in number, percentage and risk-difference)

    Time frame: 1 year

  10. Cardiovascular hospitalizations after the procedure over 1 year (in number, percentage and risk-difference)

    Time frame: 1 year

    Secondary Outcome

  11. Death after ablation procedure from cardiovascular and/or non-cardiovascular cause over 1 year (in number, percentage and risk-difference)

    Time frame: 1 year

    Secondary Outcome

  12. Need for re-do ablations for sustained ventricular tachycardia or appropriate ICD therapy after index ventricular tachycardia ablation procedure over 1 year (in number, percentage and risk-difference)

    Time frame: 1 year

    Secondary Outcome

  13. Need for anti-arrhythmic drug anytime in the first year after ablation excluding the 1-month blanking period post-ablation (in number, percentage and risk-difference)

    Time frame: 1 year

    Clinic prescription or in-hospital administration of any anti-arrhythmic class Ia, Ib, Ic, or III (including amiodarone) agents if prescribed/administered with the goal of treating or preventing ventricular arrhythmic events.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Mazur, MD

CONTACT

[email protected]

312-942-5020

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • Biosense Webster, Inc.
  • Brigham and Women's Hospital
  • Mayo Clinic
  • Medical University of South Carolina
  • University of Michigan

Registry information

Official study title

Ablation-Index Guided Scar-Mediated Ventricular Tachycardia Ablation in Patients With Ischemic Cardiomyopathy (AIM-VT) - a Prospective Single-Blinded, Multicenter Randomized Controlled Trial

Acronym: AIM-VT

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 18, 2023
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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