Unpinning Termination Therapy for VT (US)

NCT03093051 | Terminated DMC FDA Device

• 2 other identifiers: CL0052R44HL107055-02
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Ventricular Tachycardia

Keywords

Termination; Unpinning; Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

UPT Treatment

EXPERIMENTAL

Investigational therapy (UPT)

Device: Unpinning Termination therapy

Interventions

Unpinning Termination therapy DEVICE

Electrotherapy comprised of standard biphasic and monophasic pacing pulses

Also known as: Multi-Stage Therapy, Multi-Stage Electrotherapy

UPT Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Life expectancy of 1 year or greater
• Male or female between 18 and 80 years of age
• Willing and able to comply with the study protocol, provide a written informed consent
• 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)
• Etiology of arrhythmia, or risk of arrhythmia being ischemic cardiomyopathy or non-ischemic cardiomyopathy
• Medically stable at time of consent to undergo DFT testing performed under general anesthesia or conscious sedation as determined by the investigator

You may not qualify if:

• Medically unstable at time of study and unsafe to undergo DFT testing under general anesthesia or conscious sedation as determined by the investigator
• Hemodynamic instability as determined by the investigator
• 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
• Presence of intracardiac thrombus
• Inability to pass catheters to heart due to vascular limitations
• 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
• Pregnancy confirmed by test within 7 days of procedure
• Presence of a chronically implanted lead in the CS
• Presence of a ventricular assist device, including intra-aortic balloon pump
• Subjects indicated for VT ablation and experiencing VF
• Subjects requiring the use of inotropes and/or vasopressors for hemodynamic support within the 3 days prior to the study
• Prior VT catheter ablation with associated hemodynamic compromise despite pressor agents or stroke
• Incessant VT/VF or VT/VF storm within six months of scheduled procedure
• LVEF \< 20%
• New York Heart Association (NYHA) Class IV heart failure

Sponsors & Collaborators

• Cardialen, Inc.: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Washington University School of Medicine: collaborator

Study Sites (7)

Mercy Medical Group

Sacramento, California, 95819, United States

Location

MercyOne Des Moines Medical Center

Des Moines, Iowa, 50314, United States

Location

Minneapolis VA Healthcare System

Minneapolis, Minnesota, 55417, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Baylor Scott & White Heart and Vascular Hospital

Dallas, Texas, 75204, United States

Location

Related Publications (7)

• 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.

  PMID: 24076284 BACKGROUND

• 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.

  PMID: 23141483 BACKGROUND

• 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.

  PMID: 21980076 BACKGROUND

• Efimov I, Ripplinger CM. Virtual electrode hypothesis of defibrillation. Heart Rhythm. 2006 Sep;3(9):1100-2. doi: 10.1016/j.hrthm.2006.03.005. Epub 2006 Mar 10. No abstract available.

  PMID: 16945810 BACKGROUND

• 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. doi: 10.1152/ajpheart.01300.2005. Epub 2006 Feb 24.

  PMID: 16501014 BACKGROUND

• 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.

  PMID: 19560090 BACKGROUND

• 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.

  PMID: 20969974 BACKGROUND

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel H. Cooper, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients undergoing a routine clinically indicated procedure will have the investigational therapy delivered during the clinically indicated procedure.

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 28, 2017
• Study Start: April 8, 2019
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)