AzTrials
AzTrials

Ventricular TachycardiaNCT01791543

Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia

A study testing Intramural Needle Ablation Catheter in people with Ventricular Tachycardia, run by William Stevenson at 2 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

The purpose of the study is to assess the effectiveness and safety of a new device called an Intramural Needle Ablation Catheter (INA catheter). The INA catheter is used for locating and ablating ventricular arrhythmias that have failed standard radiofrequency ablation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ventricular Tachycardia
What is being tested?
Intramural Needle Ablation Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
2 sitesUnited States
Study dates
Sep 2016to 27 May 2022
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Monomorphic ventricular tachycardia (VT) or incessant ventricular arrhythmia (defined as >20% of beats due to ventricular arrhythmia including unifocal premature ventricular contractions (PVCs ), couplets, nonsustained VT) that is causing a decline in left ventricular (LV) ejection fraction to less than 0.50.
  • Arrhythmia meets the following criteria:
  • Ventricular arrhythmia is recurrent and symptomatic
  • prior antiarrhythmic drug therapy has failed due to recurrent ventricular arrhythmia, toxicity, or intolerance
  • Age 18 or older
  • Left ventricular (LV) ejection fraction > 0.10 as estimated by echocardiography or contrast ventriculography within the previous 90 days
Show all 9Show fewer
  • Failed prior VT or PVC ablation due to spontaneous recurrence of the arrhythmia or frequent PVCs.
  • Able and willing to comply with all pre-, post-, and follow-up testing and requirements
  • Signed Informed Consent

Who cannot join

  • Patients with idiopathic VT defined as VT that originates from a region without evidence of scar detected by MRI or voltage mapping in a patient without other evidence of heart disease that is not causing significant depression of ventricular function.
  • Definite protruding left ventricular thrombus on pre-ablation echocardiography when LV ablation is required.
  • Thrombotic myocardial infarction within the preceding two (2) months.
  • Other disease process that is likely to limit survival to less than 12 months.
  • Class IV heart failure, unless heart failure is due to frequent or incessant VT.
  • Contraindication to heparin.
Show all 16Show fewer
  • Allergy to radiographic contrast dye.
  • Severe aortic stenosis
  • Severe mitral regurgitation with a flail mitral valve leaflet.
  • Significant congenital anomaly or medical problem that in the opinion of the principal investigator would preclude enrollment into the study.
  • Enrolled in another investigational study evaluating a drug or device.
  • Unstable angina that is not due to frequent or incessant VT.
  • Women who are pregnant.
  • Thrombocytopenia (platelet count < 50,000) or coagulopathy.
  • Acute non-cardiovascular illness or systemic infection.
  • Cardiogenic shock unless it is due to incessant VT

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Vanderbilt Heart and Vascular Institute

    Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: Early Feasibility Study of Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia That Has Failed Conventional Radiofrequency Ablation

The purpose of the study is to assess the effectiveness and safety of a new device called an Intramural Needle Ablation Catheter (INA catheter). The INA catheter is used for locating and ablating ventricular arrhythmias that have failed standard radiofrequency ablation. This approach is desirable because some people have ventricular arrhythmias that originate deep within the heart muscle where it is not abolished by ablation with standard catheters.

The investigators seek to determine whether the INA catheter can potentially help people who have ventricular arrhythmias that have failed standard radiofrequency ablation. The investigators also want to determine if it is likely to be safe, without excessive side effects.

Being tested
Intramural Needle Ablation Catheter
Keywords
ventricular tachycardia, ablation, ventricular arrhythmia
Medical subject headings
Tachycardia, Ventricular

What participants receive

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

  • Intramural Needle Ablation CatheterDevice

Study groups in NCT01791543
Study groupRoleWhat they receive
Intramural Needle Catheter AblationExperimentalAblation of Ventricular Tachycardia with Intramural Needle Ablation Catheter
Receives: Device: Intramural Needle Ablation Catheter

What is being measured

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

  1. Number of Subjects Without Hospitalization for Ventricular Tachycardia (VT) During 6 Months

    Freedom from hospitalization for recurrent Ventricular Tachycardia during the 6 months following ablation for VT.

    Measured: 6 months

  2. Number of Participants With No Serious Adverse Events

    Absence of serious adverse events that are potentially device related and occur within 30 days of the ablation procedure

    Measured: 30 days

  3. Number of Subjects Ablated for Nonsustained Arrhythmias Who Had a Reduction to Less Than 5000 Arrhythmia Beats Daily

    Number of subjects who had ablation for nonsustained arrhythmias with ventricular dysfunction who had a decrease in ambient ventricular arrhythmia to < 5000 ventricular beats daily.

    Measured: 6 months

Secondary outcomes (1)

  1. Number of Subjects With Acute Abolition of at Least One Clinical Inducible Ventricular Tachycardia or Targeted Nonsustained Arrhythmia

    Defined as termination of at least one clinical or presumptive clinical monomorphic VT by Radiofrequency ablation and/or rendering that VT no longer inducible or abolition of a targeted nonsustained arrhythmia.

    Measured: Baseline to end of the ablation procedure (approximately 5 hours)

Timeline

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

  1. First posted15 Feb 2013 (estimated)
  2. Study startSep 2016
  3. Primary completion27 May 2022
  4. Study completion27 May 2022

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01791543
Sponsor's protocol ID
2013P000304
Status last verified
Jan 2023
First submitted
7 Feb 2013
Last updated
1 Feb 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Sapp JL, Cooper JM, Zei P, Stevenson WG. Large radiofrequency ablation lesions can be created with a retractable infusion-needle catheter. J Cardiovasc Electrophysiol. 2006 Jun;17(6):657-61. doi: 10.1111/j.1540-8167.2006.00439.x.

    PubMed 16836718

  • Sapp JL, Beeckler C, Pike R, Parkash R, Gray CJ, Zeppenfeld K, Kuriachan V, Stevenson WG. Initial human feasibility of infusion needle catheter ablation for refractory ventricular tachycardia. Circulation. 2013 Nov 19;128(21):2289-95. doi: 10.1161/CIRCULATIONAHA.113.003423. Epub 2013 Sep 13.

    PubMed 24036605

  • Schaeffer B, Tanigawa S, Nakamura T, Muthalaly RG, Sapp J, John R, Ghidoli D, Pellegrini C, Tedrow U, Stevenson WG. Characteristics of myocardial tissue staining and lesion creation with an infusion-needle ablation catheter for the treatment of ventricular tachycardia in humans. Heart Rhythm. 2020 Mar;17(3):398-405. doi: 10.1016/j.hrthm.2019.10.007. Epub 2019 Oct 8.

    PubMed 31604127

  • Stevenson WG, Tedrow UB, Reddy V, AbdelWahab A, Dukkipati S, John RM, Fujii A, Schaeffer B, Tanigawa S, Elsokkari I, Koruth J, Nakamura T, Naniwadekar A, Ghidoli D, Pellegrini C, Sapp JL. Infusion Needle Radiofrequency Ablation for Treatment of Refractory Ventricular Arrhythmias. J Am Coll Cardiol. 2019 Apr 2;73(12):1413-1425. doi: 10.1016/j.jacc.2018.12.070.

    PubMed 30922472

  • 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

  • Qian PC, Oberfeld B, Schaeffer B, Nakamura T, John RM, Sapp JL, Stevenson WG, Tedrow UB. Frequency Content of Unipolar Electrograms May Predict Deep Intramural Excitable Substrate: Insights From Intramural Needle Catheter Ablation of Ventricular Tachycardia. JACC Clin Electrophysiol. 2020 Jul;6(7):760-769. doi: 10.1016/j.jacep.2020.03.003. Epub 2020 Apr 29.

    PubMed 32703556

Questions about this trial

What is this clinical trial studying?

A study testing Intramural Needle Ablation Catheter in people with Ventricular Tachycardia, run by William Stevenson at 2 sites 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 9 inclusion and 16 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 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 1 Feb 2023). 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 Subjects Without Hospitalization for Ventricular Tachycardia (VT) During 6 Months (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT01791543, which also lists 7 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 1 Feb 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in