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Ventricular TachycardiaNCT03093051

Unpinning Termination Therapy for VT (US)

A study testing Unpinning Termination therapy in people with Ventricular Tachycardia, run by Cardialen, Inc. at 7 sites in United States.

Terminated

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

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ventricular Tachycardia
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
6 participants
Where
7 sitesUnited States
Study dates
8 Apr 2019to 1 Oct 2022
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject must meet all of the following inclusion criteria:
  • 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

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 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
Show all 32Show fewer
  • 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
  • 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 with etiology of sarcoid flare
  • 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 creatinine clearance <15 ml/min
  • 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

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • OhioHealth Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Baylor Scott & White Heart and Vascular Hospital

    Dallas, Texas, 75204

  • MercyOne Des Moines Medical Center

    Des Moines, Iowa, 50314

  • Minneapolis VA Healthcare System

    Minneapolis, Minnesota, 55417

  • Mercy Medical Group

    Sacramento, California, 95819

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

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.

Read the detailed 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).

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

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-Stage Therapy, Multi-Stage Electrotherapy

    Electrotherapy comprised of standard biphasic and monophasic pacing pulses

Study groups in NCT03093051
Study groupRoleWhat they receive
UPT TreatmentExperimentalInvestigational therapy (UPT)
Receives: Device: Unpinning Termination therapy

What is being measured

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

  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

    Measured: During 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 posted28 Mar 2017
  2. Study start8 Apr 2019
  3. Primary completion1 Oct 2022
  4. Study completion1 Oct 2022

Why it stopped: Sponsor ceased operations

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
Patients undergoing a routine clinically indicated procedure will have the investigational therapy delivered during the clinically indicated procedure.
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03093051
Sponsor's protocol ID
CL005
Other IDs
2R44HL107055-02
Status last verified
Oct 2022
First submitted
13 Mar 2017
Last updated
10 Oct 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, run by Cardialen, Inc. at 7 sites in United States.

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 7 inclusion and 32 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 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. 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: Sponsor ceased operations). 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?

Arrhythmia Termination as assessed by the number of episodes restored to sinus rhythm (time frame: During study procedure). 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 NCT03093051, 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 10 Oct 2022.

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