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Ventricular ArrythmiaNCT03204981

Intramural Needle Ablation for the Treatment of Refractory Ventricular Arrhythmias

A study testing Intramural Needle Ablation and Ablation in people with Ventricular Arrythmia, run by Vivek Reddy at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Ventricular Arrythmia
What is being tested?
Intramural Needle Ablation and Ablation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteUnited States
Study dates
17 Oct 2017to 20 Apr 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

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.

Read the detailed description

Radiofrequency (RF) ablation is the most commonly employed method for the catheter treatment of cardiac arrhythmias. Myocardial scar serves as the most frequent substrate for the genesis of both atrial and ventricular arrhythmias. Such scar frequently contains surviving myocyte bundles interspersed with fibrotic tissue, which leads to slow conduction. Areas of denser fibrosis cause conduction block. When appropriately arranged, conduction through or around these scars leads to the creation of a "reentry" circuit through which an arrhythmia is generated and maintained. Each reentry circuit contains within it an area called the isthmus, a portion of the circuit located in a position intimately related to the scar border zone. Electrical activation travels slowly through the isthmus before breaking out into normal myocardium. Ablation at the site of an isthmus will terminate a reentrant tachycardia.

A variety of techniques, including electroanatomic mapping and activation, entrainment, and substrate mapping, are employed during electrophysiologic (EP) study to identify areas of myocardial scar and potential isthmus sites. Points or lines of ablation using RF energy are then created in an attempt to interrupt the reentry circuit. Typically, RF energy is applied via a catheter tip electrode to the endocardial or epicardial surface of the heart and grounded via an electrode pad placed on the patient's skin. RF energy in this setting is dispersed through the entirety of the tissue between catheter tip and grounding pad. The standard 7-French, 4-mm tip catheters are highly successful at ablating circuits located within a few millimeters of the catheter tip. A focal, 1mm area of resistive heating occurs within the myocardium immediately in contact with the catheter tip; myocardial cell death occurs several millimeters more deeply through passive, conductive heating, which spreads outward from the contact point.

While the standard catheter is effective at the ablation of superficial arrhythmias, it has proven more problematic when used for deep myocardial sites or for creating transmural lesions. A number of alternatives have been developed in an attempt to access these sites. 8-mm or 10-mm catheter tips are able to create larger zones of resistive heating, delivering direct RF energy to a larger area of myocardium. A larger interface between catheter tip and blood improves cooling and allows for the delivery of more power without a rise in impedance.The clinical use of these larger catheters can, however, be limited by rapid temperature rises at the catheter-tissue interface, resulting in thrombus formation, char, and "steam pop" rupture of the endocardial surface. The use of irrigated ablation catheters have improved upon the ability to deliver RF energy without a sustained rise in impedance. Both open irrigated- and closed-loop irrigated catheters circulate saline along the catheter tip-myocardial interface, allowing for continued delivery of RF current without thrombus formation at the endocardial surface. Intramyocardial temperature rises accordingly without a concomitant endocardial temperature surge, creating larger and deeper myocardial ablation zones. Transcoronary ethanol ablation has also been employed with moderate success in patients with arrhythmias resistant to endocardial catheter ablation.This technology, however, grants only limited control over the size of the resulting infarct and is restricted by the need for perfusion of the scar zone by an accessible coronary artery.

Nevertheless, there remain occasions in which an arrhythmia cannot be eliminated by standard ablation techniques. This is seen most frequently due to deep intramural ventricular tachycardia, sometimes encountered following myocardial infarction. Both standard and alternative ablation strategies are frequently either unavailable or inadequate for termination of these arrhythmias.

Initial experience with an electrically active needle electrode have demonstrated that radiofrequency ablative energy can effectively create lesions of homogeneous necrosis. Needle electrodes have been used experimentally from the epicardial surface, from the endocardium ex vivo and in vivo in an internally irrigated form. It has been shown that the use of a narrow-gauge non-irrigated endocardial needle ablation catheter creates very narrow but deep lesions due to the small electrode size. Catheters featuring a retractable needle tipped electrode with intramyocardial saline infusion have also shown promise as a means of accessing deep myocardial circuits in ventricular tachycardia ablation.18

The proposed study will further examine the role of INA in patients with ventricular arrhythmias resistant to standard ablation techniques.

Being tested
Intramural Needle Ablation, Ablation
Keywords
intramural needle ablation, ventricular arrhythmia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intramural Needle AblationDevice

    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.

  • AblationProcedure or surgery

    standard ablation

Study groups in NCT03204981
Study groupRoleWhat they receive
Intramural Needle AblationExperimentalNot described
Receives: Device: Intramural Needle Ablation; Procedure: Ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (6)
  1. Number of Events of Procedural Complications

    Number of events of procedural complications

    Measured: at 6 months

  2. Number of Participants With Post-ablation Inducibility

    Measured: Day 1

  3. Time to Termination

    Measured: Day 1

  4. Total Duration of Intramural Needle Ablation

    Total duration of intramural needle ablation for patient who had ablation performed using the experimental Needle ablation catheter.

    Measured: Day 1

  5. Total Number of Intramural Needle Ablations

    Total Number of Intramural Needle Ablations for patient had ablation performed using the experimental Needle ablation catheter.

    Measured: Day 1

  6. All-cause Mortality

    Measured: at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2017
  2. Study start17 Oct 2017
  3. Primary completion20 Apr 2021
  4. Study completion20 Apr 2021

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03204981
Sponsor's protocol ID
GCO 17-1899
Status last verified
Sep 2021
First submitted
28 Jun 2017
Last updated
12 Oct 2021
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 37278684
  • 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.

    PubMed 35476455

Questions about this trial

What is this clinical trial studying?

A study testing Intramural Needle Ablation and Ablation in people with Ventricular Arrythmia, run by Vivek Reddy at 1 site 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 8 inclusion and 13 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: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 12 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Had Freedom From Ventricular Arrhythmia at 6 Months (time frame: 6 months). 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 NCT03204981, which also lists 2 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 12 Oct 2021.

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