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Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia

Primary Purpose

Ventricular Tachycardia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intramural Needle Ablation Catheter

About this trial

This is an interventional treatment trial for Ventricular Tachycardia focused on measuring ventricular tachycardia, ablation, ventricular arrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Monomorphic ventricular tachycardia 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 LV ejection fraction to less than 50%

Arrhythmia meet the following criteria:

Ventricular arrhythmia is recurrent and symptomatic
prior antiarrhythmic drug therapy has failed due to recurrent ventricular arrythmia, toxicity, or intolerance
- Age 18 or older
- Left ventricular (LV) ejection fraction > 10% as estimated by echocardiography or contrast ventriculography within the previous 90 days
- 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

Exclusion Criteria:

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.
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

Sites / Locations

Brigham and Women's Hospital
Vanderbilt Heart and Vascular Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intramural Needle Catheter Ablation

Arm Description

Ablation of Ventricular Tachycardia with Intramural Needle Ablation Catheter

Outcomes

Primary Outcome Measures

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.

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

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01791543

First Posted

February 7, 2013

Last Updated

January 5, 2023

Sponsor

William Stevenson

1. Study Identification

Unique Protocol Identification Number

NCT01791543

Brief Title

Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

September 2016 (Actual)

Primary Completion Date

May 27, 2022 (Actual)

Study Completion Date

May 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

William Stevenson

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ventricular Tachycardia

Keywords

ventricular tachycardia, ablation, ventricular arrhythmia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

115 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intramural Needle Catheter Ablation

Arm Type

Experimental

Arm Description

Ablation of Ventricular Tachycardia with Intramural Needle Ablation Catheter

Intervention Type

Device

Intervention Name(s)

Intramural Needle Ablation Catheter

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

6 months

Title

Number of Participants With No Serious Adverse Events

Description

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

Time Frame

30 days

Title

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

Description

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.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William G. Stevenson, M.D.

Organizational Affiliation

Vanderbilt Heart and Vascular Institute

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Usha Tedrow, M.D.

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Vanderbilt Heart and Vascular Institute

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16836718

Citation

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.

Results Reference

background

PubMed Identifier

24036605

Citation

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.

Results Reference

background

PubMed Identifier

31604127

Citation

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.

Results Reference

background

PubMed Identifier

30922472

Citation

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.

Results Reference

result

PubMed Identifier

35476455

Citation

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.

Results Reference

derived

PubMed Identifier

32703556

Citation

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.

Results Reference

derived

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Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia

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