Intramural Needle Ablation for the Treatment of Refractory Ventricular Arrhythmias

NCT03204981 | Completed Results DMC FDA Device

• 1 other identifier: GCO 17-1899
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ventricular Arrythmia

Keywords

intramural needle ablation; ventricular arrhythmia

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Had Freedom From Ventricular Arrhythmia at 6 Months

  Number of participants with VT and number of participants with PVCs who had freedom from ventricular arrhythmia at 6 months for participants who had ablation performed using the experimental Needle ablation catheter versus standard ablation catheter. Needle - patient had ablation performed using the experimental Needle ablation catheter. Registry - patient had ablation using a standard ablation catheter and did not need additional ablation using the Needle catheter.

  6 months

Secondary Outcomes (6)

• Number of Events of Procedural Complications

  at 6 months

• Number of Participants With Post-ablation Inducibility

  Day 1

• Time to Termination

  Day 1

• Total Duration of Intramural Needle Ablation

  Day 1

• Total Number of Intramural Needle Ablations

  Day 1

Study Arms (1)

Intramural Needle Ablation

EXPERIMENTAL

Device: Intramural Needle Ablation; Procedure: Ablation

Interventions

Intramural Needle Ablation DEVICE

The needle-tipped ablation catheter that will be used for the IN ablation uses radiofrequency like a standard RF ablation catheter, but delivers energy through an extendable/retractable needle.

Intramural Needle Ablation

Ablation PROCEDURE

standard ablation

Intramural Needle Ablation

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \<40%; or c) previous failed ablation for one or more of the criteria above.
• ≥ 15 years of age.
• Left ventricular (LV) ejection fraction \> 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vivek Reddy: lead
• Biosense Webster, Inc.: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (2)

• Tedrow UB, Kurata M, Kawamura I, Batnyam U, Dukkipati S, Nakamura T, Tanigawa S, Fuji A, Richardson TD, Kanagasundram AN, Koruth JS, John RM, Hasegawa K, Abdelwahab A, Sapp J, Reddy VY, Stevenson WG. Worldwide Experience With an Irrigated Needle Catheter for Ablation of Refractory Ventricular Arrhythmias: Final Report. JACC Clin Electrophysiol. 2023 Aug;9(8 Pt 2):1475-1486. doi: 10.1016/j.jacep.2023.05.014. Epub 2023 May 19.

  PMID: 37278684 DERIVED

• Dukkipati SR, Nakamura T, Nakajima I, Oates C, Narui R, Tanigawa S, Sljapic T, Whang W, Koruth JS, Choudry S, Schaeffer B, Fujii A, Tedrow UB, Sapp JL, Stevenson WG, Reddy VY. Intramural Needle Ablation for Refractory Premature Ventricular Contractions. Circ Arrhythm Electrophysiol. 2022 May;15(5):e010020. doi: 10.1161/CIRCEP.121.010020. Epub 2022 Apr 27.

  PMID: 35476455 DERIVED

Results Point of Contact

• Title: Sam Cammack
• Organization: Icahn School of Medicine at Mount Sinai

sam.cammack@mountsinai.org

212-824-8931

Study Officials

• Vivek Reddy, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 2, 2017
• Study Start: October 17, 2017
• Primary Completion: April 20, 2021
• Study Completion: April 20, 2021
• Last Updated: October 12, 2021
• Results First Posted: October 12, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)