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

NCT04463641 | Active Not Recruiting DMC

• 1 other identifier: LAXI01
• Study Type: interventional
• Target: 92
• Locations: 7 countries
• Sites: 21

Brief Summary

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

Conditions

Heart Failure; Cardiac Resynchronization Therapy

Keywords

Left Ventricular Lead

Outcome Measures

Primary Outcomes (2)

• 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).

  6 months

• 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.

  6 months

Secondary Outcomes (1)

• Bizone LV pacing success rate at 6 months post implant

  6 months

Other Outcomes (16)

• Axone 4LV implantation success rate

  At implant, preferably within 15 days of enrollment

• Implantation duration

  At implant, preferably within 15 days of enrollment

• Fluoroscopy time

  At implant, preferably within 15 days of enrollment

Study Arms (1)

Axone 4LV Lead

EXPERIMENTAL

Subjects implanted with the Axone 4LV Lead

Device: Implantation of the Axone 4LV Lead

Interventions

Implantation of the Axone 4LV Lead DEVICE

Implantation of the Axone 4LV Lead

Axone 4LV Lead

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• MicroPort CRM: lead

Study Sites (21)

Kepler Universitätsklinikum

Linz, Austria

Location

CH Annecy Genevois

Annecy, France

Location

CHRU Hopital Trousseau

Chambray-lès-Tours, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Location

CHU Grenoble

Grenoble, France

Location

CHRU de Lille - Hôpital Cardiologique

Lille, France

Location

CHU Pontchaillou

Rennes, France

Location

CHU de Rouen

Rouen, France

Location

CHU Toulouse

Toulouse, France

Location

Universitätsklinikum Hamburg Eppendorf

Hamburg, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, Germany

Location

ASST Spedali Civili di Brescia

Brescia, Italy

Location

Ospedale Pellegrini

Naples, Italy

Location

Ospedale Policlinico Federico II

Naples, Italy

Location

Isala Klinieken

Zwolle, Netherlands

Location

Centro Hospitalar Universitário Lisboa Norte - Hospital de Santa Maria

Lisbon, Portugal

Location

Centro Hospitalar Universitário do Porto

Porto, Portugal

Location

Hospital Universitario General de Alicante

Alicante, Spain

Location

Hospital Universitario La Fe

Valencia, Spain

Location

Hospital Álvaro Cunqueiro

Vigo, Spain

Location

Related Publications (18)

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  PMID: 27206819 BACKGROUND

• 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.

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• 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.

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• 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.

  PMID: 28494974 BACKGROUND

• 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.

  PMID: 22896584 BACKGROUND

• 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.

  PMID: 27371720 BACKGROUND

• 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.

  PMID: 29264026 BACKGROUND

• 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.

  PMID: 14967109 BACKGROUND

• 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.

  PMID: 11748094 BACKGROUND

• 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.

  PMID: 26718535 BACKGROUND

• 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.

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• 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.

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• 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.

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• 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.

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• Tomassoni G, Baker J, Corbisiero R, Love C, Martin D, Niazi I, Sheppard R, Worley S, Beau S, Greer GS, Aryana A, Cao M, Harbert N, Zhang S; Promote(R) Q CRT-D and Quartet(R) Left Ventricular Heart Lead Study Group. Postoperative performance of the Quartet(R) left ventricular heart lead. J Cardiovasc Electrophysiol. 2013 Apr;24(4):449-56. doi: 10.1111/jce.12065. Epub 2013 Jan 22.

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• Crossley GH, Biffi M, Johnson B, Lin A, Gras D, Hussin A, Cuffio A, Collier JL, El-Chami M, Li S, Holloman K, Exner DV. Performance of a novel left ventricular lead with short bipolar spacing for cardiac resynchronization therapy: primary results of the Attain Performa quadripolar left ventricular lead study. Heart Rhythm. 2015 Apr;12(4):751-8. doi: 10.1016/j.hrthm.2014.12.019. Epub 2014 Dec 19.

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MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Frédéric Anselme, MD

  CHU de Rouen, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: July 9, 2020
• Study Start: December 3, 2020
• Primary Completion: June 1, 2024
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); FR (8); IT (3); ES (3); DE (3); NL (1); PT (2)