N/A
N=52
Intramural Needle Ablation for the Treatment of Refractory Ventricular Arrhythmias
Ventricular Arrythmia
Bottom Line
View on ClinicalTrials.gov: NCT03204981 ↗Enrolled (actual)
52
Serious AEs
28.8%
Results posted
Oct 2021
Primary outcome: Primary: Number of Participants Who Had Freedom From Ventricular Arrhythmia at 6 Months — 8; 4; 5; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intramural Needle Ablation (Device); Ablation (Procedure)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Vivek Reddy
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Had Freedom From Ventricular Arrhythmia at 6 Months |
8; 4; 5; 2 | — |
| SECONDARY Number of Events of Procedural Complications |
29 | — |
| SECONDARY Number of Participants With Post-ablation Inducibility |
2 | — |
| SECONDARY Time to Termination |
322.16 | — |
| SECONDARY Total Duration of Intramural Needle Ablation |
47.14 | — |
| SECONDARY Total Number of Intramural Needle Ablations |
11.2 | — |
| SECONDARY All-cause Mortality |
— | — |
Summary
This study will examine the safety and efficacy of intramural needle ablation (INA) in the treatment of intramural ventricular arrhythmias in patients for whom standard RF ablation has been unsuccessful. The clinical team hypothesize that the increased current density and improved rates of transmural lesion creation seen with intramural needle ablation will lead to successful arrhythmia termination with minimal or no increased risk of complication.
Eligibility Criteria
Inclusion Criteria
- The study will include patients with any of the following criteria: a) monomorphic ventricular tachycardia (VT); b) frequent ventricular arrhythmia (defined as unifocal PVCs, couplets, non-sustained VT) with a PVC burden ≥13%, or is causing a decline in left ventricular (LV) ejection fraction to 10% as estimated by echocardiography, contrast ventriculography or radionuclide imaging within the past 90 days.
- Clinical indication for catheter ablation of VT
- Intramural ventricular arrhythmias not terminable with standard ablation once enrolled in the Intramural Needle Ablation study or previous failed ablation within 6 months prior to enrollment.
- Ability to understand the requirements of the study and sign the informed consent form.
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements.
- Projected lifespan greater than 1 year.
Exclusion Criteria
- History of MI or CABG within 6 weeks.
- NYHA Class IV CHF.
- Patients with idiopathic ventricular arrhythmias defined as VT or PVCs that occur without evidence of structural heart disease and that are not causing significant depression of LV function.
- Women known to be pregnant or to have positive beta-HCG.
- Definite protruding left ventricular thrombus on pre-ablation echocardiography or other imaging modalities.
- Contraindication to heparin
- Allergy to radiographic contrast dye.
- Unstable angina that is not due to frequent or incessant VT.
- Acute non-cardiovascular illness or systemic infection.
- Thrombocytopenia (platelet count < 50, 000 mm3) or coagulopathy.
- Cardiogenic shock unless it is due to incessant VT.
- Unable to sign consent.
- Projected lifespan of < 1 year.
Data sourced from ClinicalTrials.gov (NCT03204981). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.