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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intramural Needle Catheter Ablation | Experimental | Ablation of Ventricular Tachycardia with Intramural Needle Ablation Catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intramural Needle Ablation Catheter | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| 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 | 30 days |
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to end of the ablation procedure (approximately 5 hours) |
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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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William G. Stevenson, M.D. | Vanderbilt Heart and Vascular Institute | Study Director |
| Usha Tedrow, M.D. | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Vanderbilt Heart and Vascular Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16836718 | Background | 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. | |
| 24036605 | Background | 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. |
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115 unique subjects signed consent and were enrolled; 6 were consented twice (121 enrollments): 1 had no needle ablation when standard ablation was successful at both procedures; 3 had needle ablation at the first but not the second procedure; 2 had needle ablation twice and outcomes are reported for their first procedure only. Of the 115, 39 exited before treatment (standard ablation successful in 30, VT not inducible in 7, other reasons in 2). Thus, 76 unique participants started the study.
Patients referred for ablation of ventricular arrhythmias who met the entry criteria were enrolled at Vanderbilt University Medical Center or Brigham and Women's Hospital from 9/19/2016 to 8/26/2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intramural Needle Catheter Ablation | Patients meeting the entry criteria and consented for participation in the study |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intramural Needle Catheter Ablation | Patients Treated With Intramural Needle Ablation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This outcome is analyzed only for the 54 patients whose targeted arrhythmia was ventricular tachycardia. | Posted | Count of Participants | Participants | 6 months |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intramural Needle Catheter Ablation | Patients Treated With Intramural Needle Ablation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial Effusion | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femoral hematoma | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William G Stevenson, MD | Vanderbilt University Medical Center | 1-615-322-2318 | william.g.stevenson@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 16, 2020 | Aug 20, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Nashville |
| Tennessee |
| 37232 |
| United States |
| 31604127 | Background | 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. |
| 30922472 | Result | 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. |
| 37278684 | Derived | 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. |
| 35476455 | 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. |
| 32703556 | Derived | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Left Ventricular Ejection Fraction (LVEF) | Ejection fraction expressed as a fraction. | Median | Inter-Quartile Range | ejection fraction |
|
| Coronary Artery Disease | Count of Participants | Participants |
|
| Nonischemic heart diseases | Count of Participants | Participants |
|
| History of heart failure | Count of Participants | Participants |
|
| Number of prior failed ablation procedures (median, range) | Median | Full Range | prior procedures |
|
| Failed amiodarone | Count of Participants | Participants |
|
| Failed mexiletine | Count of Participants | Participants |
|
| Implanted Defibrillator | Count of Participants | Participants |
|
| Ablation for ventricular tachycardia (VT) | Count of Participants | Participants |
|
| Ablation for premature ventricular contractions (PVCs)/Nonsustained VT | Count of Participants | Participants |
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Primary | 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. | This outcome is analyzed only for the 20 patients in whom PVCs/Nonsustained VT was the targeted arrhythmia for study entry. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | 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. | This secondary efficacy endpoint was not assessed in 16 patients in whom VT induction was not attempted because in the judgment of the investigator it imposed unwarranted risk of hemodynamic deterioration. Acute success for PVC/nonsustained VT ablation was abolishing the targeted PVC.. | Posted | Count of Participants | Participants | Baseline to end of the ablation procedure (approximately 5 hours) |
|
|
|
| 5 |
| 76 |
| 13 |
| 76 |
| 5 |
| 76 |
| Pulmonary Embolism | Cardiac disorders | Non-systematic Assessment |
|
| Retroperitoneal Hematoma | Vascular disorders | Systematic Assessment |
|
| urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
| ventricular fibrillation | Cardiac disorders | Systematic Assessment | During catheter manipulation |
|
| Allergic reaction | General disorders | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | Systematic Assessment |
|
| Pulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| AV block | Cardiac disorders | Systematic Assessment |
|
| GI bleed | Gastrointestinal disorders | Non-systematic Assessment |
|
| Heart Failure Exacerbation | Cardiac disorders | Systematic Assessment |
|
| Intraperitoneal bleeding | Gastrointestinal disorders | Non-systematic Assessment |
|
| atrial fibrillation with rapid response | Cardiac disorders | Systematic Assessment |
|
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| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |