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Heart FailureASTRAL-4LVNCT04463641

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

A study testing Implantation of the Axone 4LV Lead in people with Heart Failure and Cardiac Resynchronization Therapy, run by MicroPort CRM at 21 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Implantation of the Axone 4LV Lead
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
21 sitesin 7 countries
Study dates
3 Dec 2020to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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)

Trial locations and contacts

21 sites in 7 countries.

21 sites in 7 countries

France8 sites

  • CH Annecy Genevois

    Annecy

  • CHRU Hopital Trousseau

    Chambray-lès-Tours

  • CHU de Clermont-Ferrand

    Clermont-Ferrand

  • CHU Grenoble

    Grenoble

  • CHRU de Lille - Hôpital Cardiologique

    Lille

  • CHU Pontchaillou

    Rennes

  • CHU de Rouen

    Rouen

  • CHU Toulouse

    Toulouse

Other trials in France

Germany3 sites

  • Universitätsklinikum Hamburg Eppendorf

    Hamburg

  • Universitätsklinikum Heidelberg

    Heidelberg

  • Universitätsklinikum Schleswig-Holstein Campus Kiel

    Kiel

Other trials in Germany

Italy3 sites

  • ASST Spedali Civili di Brescia

    Brescia

  • Ospedale Pellegrini

    Naples

  • Ospedale Policlinico Federico II

    Naples

Other trials in Italy

Spain3 sites

  • Hospital Universitario General de Alicante

    Alicante

  • Hospital Universitario La Fe

    Valencia

  • Hospital Álvaro Cunqueiro

    Vigo

Other trials in Spain

Portugal2 sites

  • Centro Hospitalar Universitário Lisboa Norte - Hospital de Santa Maria

    Lisbon

  • Centro Hospitalar Universitário do Porto

    Porto

Other trials in Portugal

Austria1 site

  • Kepler Universitätsklinikum

    Linz

Other trials in Austria

Netherlands1 site

  • Isala Klinieken

    Zwolle

Other trials in Netherlands

About this study

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

Read the detailed description

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.

Being tested
Implantation of the Axone 4LV Lead
Keywords
Left Ventricular Lead
Medical subject headings
Heart Failure

What participants receive

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

  • Implantation of the Axone 4LV LeadDevice

    Implantation of the Axone 4LV Lead

Study groups in NCT04463641
Study groupRoleWhat they receive
Axone 4LV LeadExperimentalSubjects implanted with the Axone 4LV Lead
Receives: Device: Implantation of the Axone 4LV Lead

What is being measured

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

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

    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).

    Measured: 6 months

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

    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.

    Measured: 6 months

Secondary outcomes (1)

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

    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.

    Measured: 6 months

Timeline

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

  1. First posted9 Jul 2020
  2. Study start3 Dec 2020
  3. Primary completionJun 2024 (estimated)
  4. Study completionDec 2027 (estimated)

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04463641
Sponsor's protocol ID
LAXI01
Acronym
ASTRAL-4LV
Status last verified
Jan 2024
First submitted
23 Jun 2020
Last updated
5 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.

    PubMed 27206819

  • Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L; Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005 Apr 14;352(15):1539-49. doi: 10.1056/NEJMoa050496. Epub 2005 Mar 7.

    PubMed 15753115

  • Linde C, Abraham WT, Gold MR, St John Sutton M, Ghio S, Daubert C; REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) Study Group. Randomized trial of cardiac resynchronization in mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure symptoms. J Am Coll Cardiol. 2008 Dec 2;52(23):1834-1843. doi: 10.1016/j.jacc.2008.08.027. Epub 2008 Nov 7.

    PubMed 19038680

  • Zeitler EP, Friedman DJ, Daubert JP, Al-Khatib SM, Solomon SD, Biton Y, McNitt S, Zareba W, Moss AJ, Kutyifa V. Multiple Comorbidities and Response to Cardiac Resynchronization Therapy: MADIT-CRT Long-Term Follow-Up. J Am Coll Cardiol. 2017 May 16;69(19):2369-2379. doi: 10.1016/j.jacc.2017.03.531.

    PubMed 28494974

  • Healey JS, Hohnloser SH, Exner DV, Birnie DH, Parkash R, Connolly SJ, Krahn AD, Simpson CS, Thibault B, Basta M, Philippon F, Dorian P, Nair GM, Sivakumaran S, Yetisir E, Wells GA, Tang AS; RAFT Investigators. Cardiac resynchronization therapy in patients with permanent atrial fibrillation: results from the Resynchronization for Ambulatory Heart Failure Trial (RAFT). Circ Heart Fail. 2012 Sep 1;5(5):566-70. doi: 10.1161/CIRCHEARTFAILURE.112.968867. Epub 2012 Aug 14.

    PubMed 22896584

  • Daubert C, Behar N, Martins RP, Mabo P, Leclercq C. Avoiding non-responders to cardiac resynchronization therapy: a practical guide. Eur Heart J. 2017 May 14;38(19):1463-1472. doi: 10.1093/eurheartj/ehw270.

    PubMed 27371720

  • Okamura H. Up-to-date cardiac resynchronization therapy. J Gen Fam Med. 2017 May 17;18(5):195-199. doi: 10.1002/jgf2.24. eCollection 2017 Oct.

    PubMed 29264026

  • Macias A, Gavira JJ, Alegria E, Azcarate PM, Barba J, Garcia-Bolao I. [Effect of the left ventricular pacing site on echocardiographic parameters of ventricular dyssynchrony in patients receiving cardiac resynchronization therapy]. Rev Esp Cardiol. 2004 Feb;57(2):138-45. Spanish.

    PubMed 14967109

  • Butter C, Auricchio A, Stellbrink C, Fleck E, Ding J, Yu Y, Huvelle E, Spinelli J; Pacing Therapy for Chronic Heart Failure II Study Group. Effect of resynchronization therapy stimulation site on the systolic function of heart failure patients. Circulation. 2001 Dec 18;104(25):3026-9. doi: 10.1161/hc5001.102229.

    PubMed 11748094

  • Umar F, Taylor RJ, Stegemann B, Marshall H, Flannigan S, Lencioni M, De Bono J, Griffith M, Leyva F. Haemodynamic effects of cardiac resynchronization therapy using single-vein, three-pole, multipoint left ventricular pacing in patients with ischaemic cardiomyopathy and a left ventricular free wall scar: the MAESTRO study. Europace. 2016 Aug;18(8):1227-34. doi: 10.1093/europace/euv396. Epub 2015 Dec 30.

    PubMed 26718535

  • Bonadei I, Vizzardi E, Gorga E, Carubelli V, Pagnoni M, Sciatti E, Raweh A, Cerini M, Bontempi L, Curnis A, Metra M. Role of the old and new echocardiographic technologies in cardiac resynchronization therapy. Minerva Cardioangiol. 2016 Oct;64(5):572-80. Epub 2015 Jun 23.

    PubMed 26099222

  • O'Brien T, Park MS, Youn JC, Chung ES. The Past, Present and Future of Cardiac Resynchronization Therapy. Korean Circ J. 2019 May;49(5):384-399. doi: 10.4070/kcj.2019.0114.

    PubMed 31074211

  • Leclercq C, Burri H, Curnis A, Delnoy PP, Rinaldi CA, Sperzel J, Lee K, Calo L, Vicentini A, Concha JF, Thibault B. Cardiac resynchronization therapy non-responder to responder conversion rate in the more response to cardiac resynchronization therapy with MultiPoint Pacing (MORE-CRT MPP) study: results from Phase I. Eur Heart J. 2019 Sep 14;40(35):2979-2987. doi: 10.1093/eurheartj/ehz109.

    PubMed 30859220

  • Auricchio A, Heggermont WA. Technology Advances to Improve Response to Cardiac Resynchronization Therapy: What Clinicians Should Know. Rev Esp Cardiol (Engl Ed). 2018 Jun;71(6):477-484. doi: 10.1016/j.rec.2018.01.006. Epub 2018 Feb 14. English, Spanish.

    PubMed 29454549

  • Antoniadis AP, Behar JM, Sieniewicz B, Gould J, Niederer S, Rinaldi CA. A comparison of the different features of quadripolar left ventricular pacing leads to deliver cardiac resynchronization therapy. Expert Rev Med Devices. 2017 Sep;14(9):697-706. doi: 10.1080/17434440.2017.1369404. Epub 2017 Aug 23.

    PubMed 28835138

Questions about this trial

What is this clinical trial studying?

A study testing Implantation of the Axone 4LV Lead in people with Heart Failure and Cardiac Resynchronization Therapy, run by MicroPort CRM at 21 sites in 7 countries.

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 3 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in France, Germany, Italy, Spain, Portugal and 2 more countries. 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?

This study is still under way. Results are not available in the source record yet.

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 co-primary endpoint, defined as Axone system related complication free rate at 6 months post implant (time frame: 6 months). The study lists 2 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 NCT04463641, which also lists 18 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 5 Jan 2024.

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