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OpenTrials
Active, Not Recruiting

NCT Number: NCT04463641

Assessment of the Axone Micro Quadripolar Lead for Enhanced Cardiac Resynchronization Therapy

The primary objective of this study is to assess the chronic safety and performance of the Axone left ventricular (LV) micro-lead.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Heart Failure Cardiac Resynchronization Therapy Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kepler Universitätsklinikum, Linz, Austria

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About this study

This is a interventional, pivotal, prospective, single arm, open label, multicenter, international trial.

The device under investigation is the Axone system, consisting of:

  • Axone 4LV: an ultrathin, lumenless, quadripolar, IS4-compatible lead designed for left ventricular pacing for cardiac resynchronization therapy (CRT).
  • Axone µGuide: a dedicated, permanently implantable micro catheter designed for implantation of the Axone 4LV lead.

The primary endpoint data will be used to support CE marking of the Axone system.

The primary endpoints will be evaluated at 6 months post-implantation. Subjects will be followed-up at 6 weeks, 3 months, 6 months, 12 months post-implantation, then yearly until 4 years post-implantation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Indication for cardiac resynchronization therapy-defibrillator (CRT-D) device implant according to the latest ESC (European Society of Cardiology) guidelines
  • De-novo implant of a Platinium 4LV CRT-D device (or any newer 4LV CRT-D model manufactured by MicroPort CRM)
  • Reviewed, signed and dated informed consent form

Exclusion criteria

  • LV lead previous implant attempt
  • Upgrade to CRT from a previously implanted pacemaker or implantable cardioverter-defibrillator (ICD), or CRT device replacement
  • Known allergy to contrast media used for imaging during cardiac catheterization
  • Tricuspid valvular disease or any type of tricuspid replacement heart valve (mechanical or tissue)
  • Severe renal failure (creatinine clearance according to the Modification of Diet in Renal Disease (MDRD) formula < 30ml/min/m²)
  • Active myocarditis
  • Stroke, myocardial infarction or cardiac revascularization within 40 days prior to implant
  • Previous heart transplant or currently on heart transplant list
  • Life expectancy less than 1 year
  • Already included in another clinical study that could confound the results of this study
  • Pre-menopausal women / women in childbearing age, including pregnant and breastfeeding women
  • Less than 18 years old or under guardianship
  • Incapacitated subject, inability to understand the purpose of the study, or to meet follow-up visits at the implanting site as defined in the protocol
  • Diagnosis of drug addiction (substance use disorder)

Treatment and study plan

Implantation of the Axone 4LV Lead

Device

Implantation of the Axone 4LV Lead

Primary outcomes

  1. Safety co-primary endpoint, defined as Axone system related complication free rate at 6 months post implant

    Time frame: 6 months

    A complication is defined as any Serious Adverse Device Effect (SADE) resulting in death or requiring invasive intervention. Safety co-primary endpoint assessment will be based on independent event adjudication by a Clinical Event Committee (CEC).

  2. Performance co-primary endpoint, defined as LV pacing success rate at 6 months post implant

    Time frame: 6 months

    LV pacing success is defined as at least one LV pacing vector with:

    • Pacing Threshold (PT) ≤ 3.5V at 1ms pulse width, and
    • No phrenic nerve stimulation at PT+2V / 1ms pulse width.

Secondary outcomes

  1. Bizone LV pacing success rate at 6 months post implant

    Time frame: 6 months

    Bizone LV pacing success is defined as two distant pacing vectors with:

    • A Pacing Threshold (PT) ≤ 3.5V at 1ms pulse width, and
    • No phrenic nerve stimulation at PT +2V / 1ms pulse width. Two pacing vectors are considered distant when cathode electrodes are separated by at least 30 mm.

Other outcomes

  1. Axone 4LV implantation success rate

    Time frame: At implant, preferably within 15 days of enrollment

  2. Implantation duration

    Time frame: At implant, preferably within 15 days of enrollment

  3. Fluoroscopy time

    Time frame: At implant, preferably within 15 days of enrollment

    Fluoroscopy time is measured in minutes

  4. Fluoroscopy dose

    Time frame: At implant, preferably within 15 days of enrollment

    Fluoroscopy dose is measured using dose area product (Gray.cm^2)

  5. Axone system handling assessment

    Time frame: At implant, preferably within 15 days of enrollment

    Implanters will be asked to fill in a handling questionnaire and record observations related to the use of the Axone system.

  6. Axone implanters' learning curve

    Time frame: At implant, preferably within 15 days of enrollment

    This endpoint will be based on fluoroscopy time for implantation. The effect of removing the 1st, 2nd, 3rd, etc implanted subjects on mean fluoroscopy time (per implanter and per site) will be calculated.

  7. Number of excitable myocardium areas at implant

    Time frame: At implant, preferably within 15 days of enrollment

    "Excitable myocardium areas" are areas that can be paced by the implanted Axone 4LV lead.

  8. Effect of CRT therapy, in particular bizone pacing, on QRS parameters, at discharge and 6 months post implant

    Time frame: At discharge, within 7 days of implant, and at 6 months

    The effect of monozone and bizone CRT pacing on duration of QRS is measured in milliseconds.

  9. Effect of CRT therapy, in particular bizone pacing, on Left Pre-Ejection Interval (LPEI), at discharge

    Time frame: At discharge, within 7 days of implant

    LPEI (in milliseconds) is an electromechanical parameter that can be assessed using echocardiography.

  10. Axone 4LV lead pacing threshold

    Time frame: Discharge (within 7 days of implant), 6 weeks, 3 months, 6 months, 12 months, 24 months 36 months, 48 months

    Pacing threshold is measured in Volts.

  11. Axone 4LV lead pacing impedance

    Time frame: Discharge (within 7 days of implant), 6 weeks, 3 months, 6 months, 12 months, 24 months 36 months, 48 months

    Pacing impedance is measured in Ohms.

  12. Presence of phrenic nerve stimulation (PNS) with the Axone 4LV lead

    Time frame: Implant (preferably within 15 days of enrollment), discharge (within 7 days of implant), 6 weeks, 3 months, 6 months

    The presence of PNS will be assessed at 10V using an external pacing system analyzer at implant, or at pacing threshold +2V at other visits.

  13. Axone 4LV lead programming

    Time frame: Discharge (within 7 days of implant), 6 weeks, 3 months, 6 months, 12 months, 24 months 36 months, 48 months

    Lead programming will be reported using: (i) pacing amplitude (Volts), pulse width (milliseconds) and pacing vector(s) selected.

  14. Energy consumption associated with Axone 4LV lead

    Time frame: 6 months

    Energy will be calculated using the formula: E=(pacing amplitude^2 x pulse width)/impedance. Energy, pacing amplitude, pulse width and impedance are measured in Joules, Volts, milliseconds, and Ohms, respectively.

  15. Axone system-related annual complication-free rate

    Time frame: 12 months, 24 months 36 months, 48 months

    Definition of Axone system related complication is the same as for primary safety endpoint.

  16. Clinical response to CRT at 12 months post implant

    Time frame: 12 months

    Clinical response will be determined by looking at functional improvement, reverse remodelling, freedom from heart failure events, and rate of non-responders:

    (i) functional improvement is defined as improvement in ≥1 NYHA (New York Heart Association) class from baseline to 12 months.

    (ii) reverse remodelling is a ≥12% increase in left ventricular end systolic volume index (LVESVi: LVESV [mL] and body surface area [m^2] will be combined to report LVESVi).

    (iii) freedom from heart failure events is defined as an absence of death or HF hospitalization.

    (iv) non-responders are all those who are not responders. A responder is defined as a subject that is not dead and who did not experience any HF hospitalization and that has a stable or improved NYHA class versus baseline.

Sponsors and collaborators

Lead sponsor

MicroPort CRM

Industry

Registry information

Acronym: ASTRAL-4LV

Important dates

Study start
2020
Primary completion
2024
Study completion
2027
First posted
Jul 9, 2020
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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