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Ventricular TachycardiaNCT03871231

Unpinning Termination Therapy for VT/VF

A study testing Unpinning Termination Therapy in people with Ventricular Tachycardia and Ventricular Fibrillation, run by Cardialen, Inc. at 4 sites in Australia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Unpinning Termination Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
4 sitesAustralia
Study dates
17 Jul 2019to 15 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • The subject must not meet any of the following exclusion criteria:
  • 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
Show all 35Show fewer
  • 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%
  • New York Heart Association (NYHA) Class IV heart failure
  • Planned epicardial VT ablation on the same day as the research study
  • History of hyper-coagulable state that could increase risk of thromboembolic events
  • History of hemodynamic compromise due to valvular heart disease requiring IV inotropes or other circulatory support.
  • Unstable coronary artery disease as determined by the investigator
  • Severe proximal three-vessel or left main coronary artery disease, without revascularization as determined by the investigators
  • History of embolic stroke, Transient Ischemic Attack or other thromboembolic event in the past 6 months
  • History of Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Congenital Heart Anomaly, Cardiac Amyloidosis, Genetic Cardiac Channelopathy or Cardiac Sarcoidosis.
  • 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)
  • Morbid obesity: BMI>39 kg/m2
  • Cognitive or mental health status that would interfere with study participation and proper informed consent
  • Presence of mechanical tricuspid valve
  • Active Endocarditis
  • Ventricular arrhythmia etiology sarcoidosis
  • Valvular ventricular tachycardia
  • Previously implanted lead is under recall by manufacturer or evidence of lead failure as determined by the investigator
  • End Stage Renal Disease on hemodialysis or peritoneal dialysis, or estimated glomerular filtration rate (eGFR) <15 ml/min
  • Right atrial or right ventricular lead implanted within 12 months prior to screening
  • Any other medical condition which may affect the outcome of this study or safety of the subject as determined by the investigator

Trial locations and contacts

4 sites in 1 country.

Australia4 sites

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • Monash Medical

    Clayton, Victoria, 3168

  • Royal Adelaide Hospital

    Norwood, South Australia, 5067

  • Gold Coast

    Southport, Queensland, 4215

Other trials in Australia

About this study

Official title: An International Clinical Feasibility Study to Evaluate the Safety and Performance of Low-Energy Unpinning Termination Therapy in Patients With VT/VF

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.

Read the detailed description

A prospective single-arm feasibility study involving acute testing of UPT electrotherapy in subjects with VT/VF during clinically indicated ventricular tachycardia catheter ablation procedure or indicated implantable cardioverter defibrillator implant, upgrade, or replacement or new CRT-D implant or upgrade to CRT-D.

The study involves up to two roll in subjects at each participating site followed by an UPT evaluation and refinement segment in which remaining subjects are enrolled until arrhythmia terminations from UPT delivery are reliably achieved. A prospective evaluation segment will be performed to compare UPT against SBS and ATP if sufficient subjects remain once reliable terminations from UPT are achieved.

Subjects will be evaluated at the visits for the Clinically-Indicated Procedure per standard of care. A single follow-up at up to 30 days post-procedure is required to assess subjects for adverse events.

Being tested
Unpinning Termination Therapy
Keywords
Termination, Unpinning, Therapy
Medical subject headings
Tachycardia, Ventricular, Ventricular Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Unpinning Termination TherapyDevice

    Also called Multi-pulse therapy, Multi-stage therapy, Multi-stage electrotherapy

    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.

Study groups in NCT03871231
Study groupRoleWhat they receive
Unpinning Termination Therapy ArmExperimentalSubjects will have VT/VF induced and the Cardialen External Stimulation System (CESS) device will deliver electrical stimulation to terminate the arrhythmia
Receives: Device: Unpinning Termination Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of UPT therapy

    Adverse events

    Measured: Study procedure and 30 day post procedure

  2. Safety of UPT therapy

    Adverse events

    Measured: 30 day post procedure

  3. Parameters at which UPT terminates VT and VF

    Voltage

    Measured: Study procedure

Secondary outcomes (2)

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

    Voltage

    Measured: Study procedure

  2. Voltage at which UPT and ATP terminate VT

    Voltage

    Measured: Study procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2019
  2. Study start17 Jul 2019
  3. Primary completion15 Jul 2021
  4. Study completion15 Jul 2021

Why it stopped: Lack of enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
Non-randomized, non-blinded, prospective, single-arm, acute, early-feasibility study
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03871231
Sponsor's protocol ID
CL006
Status last verified
Aug 2022
First submitted
5 Mar 2019
Last updated
11 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 24076284

  • 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.

    PubMed 23141483

  • 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.

    PubMed 21980076

  • 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.

    PubMed 16945810

  • 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.

    PubMed 16501014

  • 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.

    PubMed 19560090

  • 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.

    PubMed 20969974

Questions about this trial

What is this clinical trial studying?

A study testing Unpinning Termination Therapy in people with Ventricular Tachycardia and Ventricular Fibrillation, run by Cardialen, Inc. at 4 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of UPT therapy (time frame: Study procedure and 30 day post procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03871231, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.

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Unpinning Termination Therapy for VT/VF (NCT03871231) | AzTrials