Unpinning Termination Therapy for VT/VF

NCT03871231 | Terminated DMC FDA Device

• 1 other identifier: CL006
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 4

Brief Summary

This study is intended to develop a better method for stopping potentially lethal heart rhythms than currently available defibrillators. This new method, called Unpinning Termination Therapy (UPT), is hypothesized to be effective in stopping these dangerous heart rhythms at lower voltages and energy than current defibrillators. Consequently, UPT may improve survival, reduce patient pain from shocks, and lead to longer lasting and smaller implantable defibrillators.

Conditions

Ventricular Tachycardia; Ventricular Fibrillation

Keywords

Termination; Unpinning; Therapy

Outcome Measures

Primary Outcomes (3)

• Safety of UPT therapy

  Adverse events

  Study procedure and 30 day post procedure

• Safety of UPT therapy

  Adverse events

  30 day post procedure

• Parameters at which UPT terminates VT and VF

  Voltage

  Study procedure

Secondary Outcomes (2)

• Voltage at which UPT and endocardial single biphasic shock terminate VT/VF

  Study procedure

• Voltage at which UPT and ATP terminate VT

  Study procedure

Study Arms (1)

Unpinning Termination Therapy Arm

EXPERIMENTAL

Subjects will have VT/VF induced and the Cardialen External Stimulation System (CESS) device will deliver electrical stimulation to terminate the arrhythmia

Device: Unpinning Termination Therapy

Interventions

Unpinning Termination Therapy DEVICE

The Cardialen External Stimulation System (CESS) is the research delivery system for the proprietary Cardialen Unpinning Therapy (UPT) therapy. The CESS is a custom designed and built research device. It is comprised of off-the-shelf commercial components (power supplies, waveform generators, laptop computer, monitor, rack, ECG system, leads, etc.) combined with a custom electrical circuit board and custom software.

Also known as: Multi-pulse therapy, Multi-stage therapy, Multi-stage electrotherapy

Unpinning Termination Therapy Arm

Eligibility Criteria

• Age: 18 Years - 75 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 75 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 sustained, life-threatening monomorphic VT OR an indication for VF and ICD implant (de novo implant, replacement or upgrade) OR CRT-D (de novo implant, upgrade from ICD) with transvenous leads for the risk of or presence of VT and/or VF.
• Etiology of arrhythmia, or risk of arrhythmia being ischemic dilated cardiomyopathy or non-ischemic idiopathic dilated cardiomyopathy both with LVEF ≤ 35% and meeting local standard of care
• 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 for ≥ 48 hours or unknown duration, and no anticoagulation for preceding 3 weeks and no preoperative transesophageal echocardiographic confirmation of the absence of RA and LA thrombus
• AF or atrial flutter for \<48 hours and no Preoperative transesophageal echocardiographic confirmation of the absence of RA and 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
• Pacemaker dependent
• The presence of a normally functioning left ventricular lead which is not planned for revision
• Presence of ventricular assist device, including Intra-aortic balloon pump
• Subjects requiring the use of I.V. inotropes and/or vasopressors for hemodynamic support in the 14 days prior to the study
• Prior VT catheter ablation with associated serious complication, such as hemodynamic compromise despite pressor agents, stroke, cardiac perforation, AC fistula, pneumothorax, sepsis
• Incessant VT/VF or VT/VF storm
• LVEF \< 20%

Sponsors & Collaborators

• Cardialen, Inc.: lead
• Genae: collaborator
• Five Corners: collaborator

Study Sites (4)

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Gold Coast

Southport, Queensland, 4215, Australia

Location

Royal Adelaide Hospital

Norwood, South Australia, 5067, Australia

Location

Monash Medical

Clayton, Victoria, 3168, Australia

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; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Harris Haqqani, MD

  The Prince Charles Hospital

  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: Non-randomized, non-blinded, prospective, single-arm, acute, early-feasibility study

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 12, 2019
• Study Start: July 17, 2019
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)