Clincosm LogoSign in Get a demo

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

Sponsor
University of Pennsylvania (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05828667
Collaborator
(none)
20
Enrollment
2
Arms
33
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Incorporation of CT and/or c-MRI derived myocardial scar with 3D electroanatomical mapping (EAM).
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A randomized controlled non-blinded prospective single-center studyA randomized controlled non-blinded prospective single-center study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The STandard Versus ImAging SuBstrate Aided Ablation in Severe Left VEntricular
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard of Care Arm

Standard of care procedural steps per respective institution and attending physician's clinical practice.
Experimental: Imaging-aided VT ablation

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

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

Outcome Measures

Primary Outcome Measures

  1. Major adverse cardiovascular events (MACE) [during hospital stay following ablation procedure, up to 1 week]

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

  2. Number of Participants Requiring Mechanical circulatory support use [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

  3. Number of Participants Requiring Inotropic support use [During the procedure, 24-48 hours after the ablation procedure]

    Incidence of inotropic and vasoactive agents use

  4. Number of Participants With Clinically Significant Pericardial Effusion [During the procedure, up to 24 hours after the ablation procedure]

    Assessing clinically significant pericardial effusion causing hemodynamic instability

  5. Number of Participants With Acute kidney injury [During procedure, up to 24-48 hours after the ablation procedure]

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

  6. Number of Participants Requiring intubation [During procedure, 24 hours after the ablation procedure]

    Need for intubation

Secondary Outcome Measures

  1. Experimental procedural duration [During procedure]

    Experimental procedural duration

  2. noninvasive programmed stimulation (NIPS) sub-acutely after the procedure [24-48 hours after the procedure.]

    comparable freedom from VT at noninvasive programmed stimulation (NIPS) sub-acutely after the procedure and at two-year follow-up.

  3. Mean and peak procedural lactate level [During procedure]

    Mean and peak procedural lactate level

  4. Cumulative procedural inotropic support use [During procedure, 24-48 hours after the ablation procedure]

    Cumulative procedural inotropic support use

  5. Hospital stay length following the procedure [Periprocedural hospital stay length, up to 2 weeks]

    Hospital stay length following the procedure

  6. Time to ventricular tachycardia (VT) [1 year]

    Time to recurrent VT or censoring at 1 year (detection 10 bpm < rate of slowest VT)

  7. Antiarrhythmic Drugs requirement [Through study completion, an average of 1 year]

    Antiarrhythmic Drugs requirement following the procedure

  8. Left ventricular ejection fraction (LVEF) [6 months after the study]

    Change in LVEF at 6 months at regular clinic follow-ups following the procedure

  9. Left ventricular end-diastolic volume (EDV) [6 months after the study]

    Change in EDV at 6 months at regular clinic follow-ups following the procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT05828667
Other Study ID Numbers:
  • 851281
First Posted:
Apr 25, 2023
Last Update Posted:
Apr 25, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cardiovascular Diseases

Study Results

No Results Posted as of Apr 25, 2023