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Intramural Needle Ablation for the Treatment of Refractory Ventricular Arrhythmias

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03204981
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : December 2, 2019
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Vivek Reddy, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Ventricular Arrythmia Device: Intramural Needle Ablation Procedure: Ablation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Intramural Needle Ablation for the Treatment of Refractory Ventricular Arrhythmias
Actual Study Start Date : October 17, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Intramural Needle Ablation Device: Intramural Needle Ablation
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.

Procedure: Ablation
standard ablation




Primary Outcome Measures :
  1. Number of recurrent ventricular arrhythmias [ Time Frame: at 6 months ]
    freedom from recurrent ventricular arrhythmias


Secondary Outcome Measures :
  1. Number of procedural complications [ Time Frame: at 6 months ]
  2. Post-ablation inducibility [ Time Frame: Day 1 ]
  3. Time to termination [ Time Frame: Day 1 ]
  4. Total duration of intramural needle ablation [ Time Frame: Day 1 ]
  5. All-cause mortality [ Time Frame: at 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 <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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03204981


Contacts
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Contact: Sam Cammack, MA, MPH 212-824-8931 sam.cammack@mountsinai.org
Contact: Betsy Ellsworth, ANP 212-824-8902 betsy.ellsworth@mountsinai.org

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Sam Cammack, MA, MPH    212-824-8931    sam.cammack@mountsinai.org   
Contact: Betsy Ellsworth, ANP    212-824-8902    betsy.ellsworth@mountsinai.org   
Principal Investigator: Vivek Reddy, MD         
Sponsors and Collaborators
Vivek Reddy
Biosense Webster, Inc.
Investigators
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Principal Investigator: Vivek Reddy, MD Icahn School of Medicine at Mount Sinai

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Responsible Party: Vivek Reddy, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03204981    
Other Study ID Numbers: GCO 17-1899
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Vivek Reddy, Icahn School of Medicine at Mount Sinai:
intramural needle ablation
ventricular arrhythmia