Unpinning Termination Therapy for VT (US)

Ventricular Tachycardia Clinical Trial

Official title:

A Clinical Feasibility Study to Evaluate the Safety and Performance of Low-Energy Unpinning Termination Therapy in Patients With VT

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03093051
• Other study ID #: CL005
• Secondary ID: 2R44HL107055-02
• Status: Terminated
• Phase: N/A
• Start date: April 8, 2019
• Est. completion date: October 1, 2022

Study information

• Verified date: October 2022
• Source: Cardialen, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This observation study evaluates the safety and performance of UPT therapy in subjects during either an indicated ventricular tachycardia ablation procedure or an ICD implant procedure.

Description:

This non-blinded, single-arm open-label, phase 1 pilot, acute research feasibility trial aims to demonstrate that the safety and effectiveness of Unpinning Termination (UPT) electrotherapy observed in the canine can be translated to humans and to demonstrate the safety and performance of UPT electrotherapy in the human population most likely to benefit from this therapy. This study evaluates the safety and performance of UPT therapy in subjects during either an indicated ventricular tachycardia (VT) catheter ablation or an indicated initial implant or device replacement of an implantable cardioverter defibrillator (ICD).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

The subject must meet all of the following inclusion criteria:

1. Life expectancy of 1 year or greater

2. Male or female between 18 and 80 years of age

3. Willing and able to comply with the study protocol, provide a written informed consent

4. Indication for an endocardial VT catheter ablation for symptomatic VT with use of CESS V1.0 or CESS V1.1 OR an indication for an ICD procedure (de novo implant, replacement or upgrade) or de novo CRTD procedure for the risk of or presence of VT (CESS 1.0 and 1.1)

5. Etiology of arrhythmia, or risk of arrhythmia being ischemic cardiomyopathy or non-ischemic cardiomyopathy

6. Medically stable at time of consent to undergo DFT testing performed under general anesthesia or conscious sedation as determined by the investigator

Exclusion Criteria:

The subject must not meet any of the following exclusion criteria:

1. Medically unstable at time of study and unsafe to undergo DFT testing under general anesthesia or conscious sedation as determined by the investigator

2. Hemodynamic instability as determined by the investigator

3. AF or atrial flutter at time of Study Procedure and no anticoagulation for preceding 3 weeks and no preoperative transesophageal echocardiographic, Cardiac CT or Intracardiac echocardiographic confirmation of the absence of LA thrombus

4. Presence of intracardiac thrombus

5. Inability to pass catheters to heart due to vascular limitations

6. Cardiovascular anatomical defects that would complicate placement of the lead or catheter required by the protocol, including congenital heart disease and cardiac vein anomalies as determined by the investigator

7. Pregnancy confirmed by test within 7 days of procedure

8. Presence of a chronically implanted lead in the CS

9. Presence of a ventricular assist device, including intra-aortic balloon pump

10. Subjects indicated for VT ablation and experiencing VF

11. Subjects requiring the use of inotropes and/or vasopressors for hemodynamic support within the 3 days prior to the study

12. Prior VT catheter ablation with associated hemodynamic compromise despite pressor agents or stroke

13. Incessant VT/VF or VT/VF storm within six months of scheduled procedure

14. LVEF < 20%

15. New York Heart Association (NYHA) Class IV heart failure

16. Planned epicardial VT ablation on the same day as the research study

17. History of hyper-coagulable state that could increase risk of thromboembolic events

18. History of hemodynamic compromise due to valvular heart disease requiring IV inotropes or other circulatory support

19. Unstable coronary artery disease as determined by the investigator

20. Severe proximal three-vessel or left main coronary artery disease, without revascularization as determined by the investigators

21. History of embolic stroke, Transient Ischemic Attack or other thromboembolic event in the past 6 months

22. History of Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Congenital Heart Anomaly, Cardiac Amyloidosis, Genetic Cardiac Channelopathy or Cardiac Sarcoidosis

23. Cardiovascular surgery or intervention within 1 month prior to enrollment or planned for up to 1 month after enrollment (other than the planned treatment procedure)

24. Morbid obesity: BMI>39 kg/m2

25. Cognitive or mental health status that would interfere with study participation and proper informed consent

26. Presence of mechanical tricuspid valve

27. Active Endocarditis

28. Ventricular arrhythmia with etiology of sarcoid flare

29. Previously implanted lead is under recall by manufacturer or evidence of lead failure as determined by the investigator

30. End Stage Renal Disease on hemodialysis or peritoneal dialysis, or creatinine clearance <15 ml/min

31. Any other medical condition which may affect the outcome of this study or safety of the subject as determined by the investigator

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Device:
• Unpinning Termination therapy
Electrotherapy comprised of standard biphasic and monophasic pacing pulses

Locations

Country	Name	City	State
United States	OhioHealth Riverside Methodist Hospital	Columbus	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Baylor Scott & White Heart and Vascular Hospital	Dallas	Texas
United States	MercyOne Des Moines Medical Center	Des Moines	Iowa
United States	Minneapolis VA Healthcare System	Minneapolis	Minnesota
United States	Mercy Medical Group	Sacramento	California
United States	Washington University	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Cardialen, Inc.	National Heart, Lung, and Blood Institute (NHLBI), Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (7)

Ambrosi CM, Ripplinger CM, Efimov IR, Fedorov VV. Termination of sustained atrial flutter and fibrillation using low-voltage multiple-shock therapy. Heart Rhythm. 2011 Jan;8(1):101-8. doi: 10.1016/j.hrthm.2010.10.018. Epub 2010 Oct 19. — View Citation

Efimov I, Ripplinger CM. Virtual electrode hypothesis of defibrillation. Heart Rhythm. 2006 Sep;3(9):1100-2. Epub 2006 Mar 10. — View Citation

Janardhan AH, Gutbrod SR, Li W, Lang D, Schuessler RB, Efimov IR. Multistage electrotherapy delivered through chronically-implanted leads terminates atrial fibrillation with lower energy than a single biphasic shock. J Am Coll Cardiol. 2014 Jan 7-14;63(1):40-8. doi: 10.1016/j.jacc.2013.07.098. Epub 2013 Sep 26. — View Citation

Janardhan AH, Li W, Fedorov VV, Yeung M, Wallendorf MJ, Schuessler RB, Efimov IR. A novel low-energy electrotherapy that terminates ventricular tachycardia with lower energy than a biphasic shock when antitachycardia pacing fails. J Am Coll Cardiol. 2012 Dec 11;60(23):2393-8. doi: 10.1016/j.jacc.2012.08.1001. Epub 2012 Nov 7. — View Citation

Li W, Janardhan AH, Fedorov VV, Sha Q, Schuessler RB, Efimov IR. Low-energy multistage atrial defibrillation therapy terminates atrial fibrillation with less energy than a single shock. Circ Arrhythm Electrophysiol. 2011 Dec;4(6):917-25. doi: 10.1161/CIRCEP.111.965830. Epub 2011 Oct 6. — View Citation

Li W, Ripplinger CM, Lou Q, Efimov IR. Multiple monophasic shocks improve electrotherapy of ventricular tachycardia in a rabbit model of chronic infarction. Heart Rhythm. 2009 Jul;6(7):1020-7. doi: 10.1016/j.hrthm.2009.03.015. Epub 2009 Mar 11. — View Citation

Ripplinger CM, Krinsky VI, Nikolski VP, Efimov IR. Mechanisms of unpinning and termination of ventricular tachycardia. Am J Physiol Heart Circ Physiol. 2006 Jul;291(1):H184-92. Epub 2006 Feb 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arrhythmia Termination as assessed by the number of episodes restored to sinus rhythm	Assess the safety and performance of the Cardialen External Stimulation System and safety and performance ofUPT therapy	During study procedure