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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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This is a multicenter, prospective, parallel, randomized controlled trial to test for non-inferiority with an ILAM-guided VT ablation compared to conventional voltage- based ablation. The study has two treatment arms: conventional voltage mapping and ablation (control arm). In the investigational arm, the ablation strategy is guided by ILAM to target deceleration zones, blinded to voltage mapping. In the control arm, ablation will be performed to extensively ablate all low voltage regions (<1.5mV) during sinus rhythm, right ventricular (RV) pacing, or left ventricular (LV) pacing, with discretionary use of pacemapping and activation mapping. In both arms, mapping with be performed with a multielectrode catheter (HD Grid) and ablation will be performed using an irrigated tip catheter (FlexAbility SE or Tactiflex catheters).
In the control armonly voltage mapping displays will be utilized (blinded to functional ILAM and fractionation). High density mapping with automated last deflection annotation (Ensite X) will be performed in all patients randomized to ILAM approach during either sinus rhythm or RV pacing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Density Voltage Mapping | Active Comparator | high-density voltage mapping will serve as the method to display the electroanatomic substrate for extensive and diffuse ablation within the low voltage area (<1.5 mV) |
|
| Isochronal Late Activation Mapping (ILAM) | Experimental | an isochronal late activation mapping (ILAM) display with automated last deflection annotation (EnSite Xâ„¢) will be used to identify regions of isochronal crowding around a line of conduction block for targeted ablation therapy using a standard irrigated tip catheter (Flexability SE & Tactiflex catheters). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isochronal Late Activation Mapping (ILAM) | Device | an isochronal late activation mapping (ILAM) display with automated last deflection annotation (EnSite Xâ„¢) will be used to identify regions of isochronal crowding around a line of conduction block for targeted ablation therapy using a standard irrigated tip catheter (Flexability SE & Tactiflex catheters) |
| Measure | Description | Time Frame |
|---|---|---|
| Inducibility for VT | Inducibility for VT after initial 25 minutes of ablation (minutes of radiofrequency) | after initial 25 minutes of ablation (minutes of radiofrequency) |
| Recurrent VT | recurrent VT at 1 year | 1 year post procedure |
| CV Hospitalization | Hospitalization due to Cardiovascular complications related to heart failure or arrhythmia at 1 year | 1 year post procedure |
| Mortality | Mortality at 1 year | 1 year post procedure |
| Procedure Related Safety | hematoma requiring transfusion, cardiac perforation, stroke, hemorrhage, pericardial effusion | Duration of Hospitalization (up to 7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Individual assessment of four endpoints comprising the primary endpoint. | Individual assessment of four individual endpoints comprising the primary endpoint. | 1 year post procedure |
| Total radiofrequency time delivered and procedural time. |
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Criteria
To participate in this clinical investigation, the subjects must meet all of the following inclusion criteria:
Patient is ≥18 years of age.
Able and willing to comply with all study requirements.
At least one documented episode of sustained MMVT (>30 sec) by either EGM or ECG (including Holter, or loop recorder) in the 6 months prior to enrollment.
Informed of the nature of the study, agreed to its provisions, and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical study site.
Refractory (i.e., not effective, not tolerated, or not desired) to at least one anti-arrhythmic medication (including, but not limited to beta blocker, mexiletine, amiodarone or sotalol) for treatment of MMVT.
Structural heart disease (ischemic or non-ischemic) with one of the following (a, b or c):
Exclusion Criteria
Subjects who meet any of the following exclusion criteria must be excluded from the clinical investigation:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Priyanka Sharma | Contact | 602-521-3090 | priyankasharma1@arizona.edu | |
| Dalise Shatz | Contact | 602-839-4540 | daliseshatz@arizona.edu |
| Name | Affiliation | Role |
|---|---|---|
| Roderick Tung, MD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center Phoenix | Phoenix | Arizona | 85006 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23741057 | Background | Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL. 2013 ACCF/AHA guideline for the management of heart failure: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013 Oct 15;128(16):1810-52. doi: 10.1161/CIR.0b013e31829e8807. Epub 2013 Jun 5. No abstract available. | |
| 18929327 |
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randomized controlled clinical trial with 1:1 randomization to two strategies for ventricular tachycardia (VT) mapping and ablation.
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|
| High Density Voltage Mapping | Device | high-density voltage mapping will serve as the method to display the electroanatomic substrate for extensive and diffuse ablation within the low voltage area (<1.5 mV). |
|
| Duration of Procedure |
| Reduction in VT burden | 1 year post procedure |
| Quality of Life improvement | The overall quality of life will be assessed using the SF-36 instrument, which includes 36 items rated on a 4-point Likert scale. In all nine subscales, lower scores indicate poorer outcomes in various areas, including physical functioning, social limitations due to physical or mental health issues, challenges related to work or daily activities, and feelings of nervousness, depression, fatigue, exhaustion, and pain. | 1 year post procedure |
| Procedural complications | tamponade, hematoma requiring transfusion, stroke, emergent surgery | Duration of Hospitalization (up to 7 days) |
| Length of stay in hospital from index procedure | Duration of Hospitalization (up to 7 days) |
| Rate of Acute Kidney Injury | Number of Participants with acute kidney injury, verified by creatinine checked the day after ablation. | 1 day post procedure |
| Background |
| Seiler J, Roberts-Thomson KC, Raymond JM, Vest J, Delacretaz E, Stevenson WG. Steam pops during irrigated radiofrequency ablation: feasibility of impedance monitoring for prevention. Heart Rhythm. 2008 Oct;5(10):1411-6. doi: 10.1016/j.hrthm.2008.07.011. Epub 2008 Jul 10. |
| 22492578 | Background | Jais P, Maury P, Khairy P, Sacher F, Nault I, Komatsu Y, Hocini M, Forclaz A, Jadidi AS, Weerasooryia R, Shah A, Derval N, Cochet H, Knecht S, Miyazaki S, Linton N, Rivard L, Wright M, Wilton SB, Scherr D, Pascale P, Roten L, Pederson M, Bordachar P, Laurent F, Kim SJ, Ritter P, Clementy J, Haissaguerre M. Elimination of local abnormal ventricular activities: a new end point for substrate modification in patients with scar-related ventricular tachycardia. Circulation. 2012 May 8;125(18):2184-96. doi: 10.1161/CIRCULATIONAHA.111.043216. Epub 2012 Apr 4. |
| 32192682 | Background | Jiang R, Beaser AD, Aziz Z, Upadhyay GA, Nayak HM, Tung R. High-Density Grid Catheter for Detailed Mapping of Sinus Rhythm and Scar-Related Ventricular Tachycardia: Comparison With a Linear Duodecapolar Catheter. JACC Clin Electrophysiol. 2020 Mar;6(3):311-323. doi: 10.1016/j.jacep.2019.11.007. Epub 2020 Jan 29. |
| 30033360 | Background | Raiman M, Tung R. Automated isochronal late activation mapping to identify deceleration zones: Rationale and methodology of a practical electroanatomic mapping approach for ventricular tachycardia ablation. Comput Biol Med. 2018 Nov 1;102:336-340. doi: 10.1016/j.compbiomed.2018.07.012. Epub 2018 Jul 18. |
| 20172911 | Background | Marcus FI, McKenna WJ, Sherrill D, Basso C, Bauce B, Bluemke DA, Calkins H, Corrado D, Cox MG, Daubert JP, Fontaine G, Gear K, Hauer R, Nava A, Picard MH, Protonotarios N, Saffitz JE, Sanborn DM, Steinberg JS, Tandri H, Thiene G, Towbin JA, Tsatsopoulou A, Wichter T, Zareba W. Diagnosis of arrhythmogenic right ventricular cardiomyopathy/dysplasia: proposed modification of the task force criteria. Circulation. 2010 Apr 6;121(13):1533-41. doi: 10.1161/CIRCULATIONAHA.108.840827. Epub 2010 Feb 19. |
| 25740836 | Background | Irie T, Yu R, Bradfield JS, Vaseghi M, Buch EF, Ajijola O, Macias C, Fujimura O, Mandapati R, Boyle NG, Shivkumar K, Tung R. Relationship between sinus rhythm late activation zones and critical sites for scar-related ventricular tachycardia: systematic analysis of isochronal late activation mapping. Circ Arrhythm Electrophysiol. 2015 Apr;8(2):390-9. doi: 10.1161/CIRCEP.114.002637. Epub 2015 Mar 4. |
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| 20488307 | Background | Nakahara S, Tung R, Ramirez RJ, Michowitz Y, Vaseghi M, Buch E, Gima J, Wiener I, Mahajan A, Boyle NG, Shivkumar K. Characterization of the arrhythmogenic substrate in ischemic and nonischemic cardiomyopathy implications for catheter ablation of hemodynamically unstable ventricular tachycardia. J Am Coll Cardiol. 2010 May 25;55(21):2355-65. doi: 10.1016/j.jacc.2010.01.041. |
| 21056123 | Background | Tung R, Nakahara S, Ramirez R, Gui D, Magyar C, Lai C, Fishbein M, Shivkumar K. Accuracy of combined endocardial and epicardial electroanatomic mapping of a reperfused porcine infarct model: a comparison of electrofield and magnetic systems with histopathologic correlation. Heart Rhythm. 2011 Mar;8(3):439-47. doi: 10.1016/j.hrthm.2010.10.044. Epub 2010 Nov 4. |
| 20653813 | Background | Tung R, Nakahara S, Maccabelli G, Buch E, Wiener I, Boyle NG, Carbucicchio C, Bella PD, Shivkumar K. Ultra high-density multipolar mapping with double ventricular access: a novel technique for ablation of ventricular tachycardia. J Cardiovasc Electrophysiol. 2011 Jan;22(1):49-56. doi: 10.1111/j.1540-8167.2010.01859.x. |
| 26031376 | Background | Tung R, Vaseghi M, Frankel DS, Vergara P, Di Biase L, Nagashima K, Yu R, Vangala S, Tseng CH, Choi EK, Khurshid S, Patel M, Mathuria N, Nakahara S, Tzou WS, Sauer WH, Vakil K, Tedrow U, Burkhardt JD, Tholakanahalli VN, Saliaris A, Dickfeld T, Weiss JP, Bunch TJ, Reddy M, Kanmanthareddy A, Callans DJ, Lakkireddy D, Natale A, Marchlinski F, Stevenson WG, Della Bella P, Shivkumar K. Freedom from recurrent ventricular tachycardia after catheter ablation is associated with improved survival in patients with structural heart disease: An International VT Ablation Center Collaborative Group study. Heart Rhythm. 2015 Sep;12(9):1997-2007. doi: 10.1016/j.hrthm.2015.05.036. Epub 2015 May 30. |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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