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Assessment of the Axone Micro Quadripolar Lead for Enhanced Cardiac Resynchronization Therapy (ASTRAL-4LV)

Primary Purpose

Heart Failure, Cardiac Resynchronization Therapy

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Implantation of the Axone 4LV Lead
Sponsored by
MicroPort CRM
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Left Ventricular Lead

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Kepler UniversitätsklinikumRecruiting
  • CH Annecy GenevoisRecruiting
  • CHRU Hopital TrousseauRecruiting
  • CHU de Clermont-FerrandRecruiting
  • CHU GrenobleRecruiting
  • CHRU de Lille - Hôpital CardiologiqueRecruiting
  • CHU PontchaillouRecruiting
  • CHU de RouenRecruiting
  • CHU ToulouseRecruiting
  • Universitätsklinikum Hamburg EppendorfRecruiting
  • Universitätsklinikum Heidelberg
  • Universitätsklinikum Schleswig-Holstein Campus KielRecruiting
  • ASST Spedali Civili di BresciaRecruiting
  • Ospedale Pellegrini
  • Ospedale Policlinico Federico IIRecruiting
  • Isala KliniekenRecruiting
  • Centro Hospitalar Universitário Lisboa Norte - Hospital de Santa MariaRecruiting
  • Centro Hospitalar Universitário do PortoRecruiting
  • Hospital Universitario General de AlicanteRecruiting
  • Hospital Universitario La FeRecruiting
  • Hospital Álvaro CunqueiroRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Axone 4LV Lead

Arm Description

Subjects implanted with the Axone 4LV Lead

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 23, 2020
Last Updated
October 11, 2022
Sponsor
MicroPort CRM
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1. Study Identification

Unique Protocol Identification Number
NCT04463641
Brief Title
Assessment of the Axone Micro Quadripolar Lead for Enhanced Cardiac Resynchronization Therapy
Acronym
ASTRAL-4LV
Official Title
Assessment of the Axone Micro Quadripolar Lead for Enhanced Cardiac Resynchronization Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 3, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MicroPort CRM

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Cardiac Resynchronization Therapy
Keywords
Left Ventricular Lead

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Axone 4LV Lead
Arm Type
Experimental
Arm Description
Subjects implanted with the Axone 4LV Lead
Intervention Type
Device
Intervention Name(s)
Implantation of the Axone 4LV Lead
Intervention Description
Implantation of the Axone 4LV Lead
Primary Outcome Measure Information:
Title
Safety co-primary endpoint, defined as Axone system related complication free rate at 6 months post implant
Description
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).
Time Frame
6 months
Title
Performance co-primary endpoint, defined as LV pacing success rate at 6 months post implant
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Bizone LV pacing success rate at 6 months post implant
Description
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.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Axone 4LV implantation success rate
Time Frame
At implant, preferably within 15 days of enrollment
Title
Implantation duration
Time Frame
At implant, preferably within 15 days of enrollment
Title
Fluoroscopy time
Description
Fluoroscopy time is measured in minutes
Time Frame
At implant, preferably within 15 days of enrollment
Title
Fluoroscopy dose
Description
Fluoroscopy dose is measured using dose area product (Gray.cm^2)
Time Frame
At implant, preferably within 15 days of enrollment
Title
Axone system handling assessment
Description
Implanters will be asked to fill in a handling questionnaire and record observations related to the use of the Axone system.
Time Frame
At implant, preferably within 15 days of enrollment
Title
Axone implanters' learning curve
Description
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.
Time Frame
At implant, preferably within 15 days of enrollment
Title
Number of excitable myocardium areas at implant
Description
"Excitable myocardium areas" are areas that can be paced by the implanted Axone 4LV lead.
Time Frame
At implant, preferably within 15 days of enrollment
Title
Effect of CRT therapy, in particular bizone pacing, on QRS parameters, at discharge and 6 months post implant
Description
The effect of monozone and bizone CRT pacing on duration of QRS is measured in milliseconds.
Time Frame
At discharge, within 7 days of implant, and at 6 months
Title
Effect of CRT therapy, in particular bizone pacing, on Left Pre-Ejection Interval (LPEI), at discharge
Description
LPEI (in milliseconds) is an electromechanical parameter that can be assessed using echocardiography.
Time Frame
At discharge, within 7 days of implant
Title
Axone 4LV lead pacing threshold
Description
Pacing threshold is measured in Volts.
Time Frame
Discharge (within 7 days of implant), 6 weeks, 3 months, 6 months, 12 months, 24 months 36 months, 48 months
Title
Axone 4LV lead pacing impedance
Description
Pacing impedance is measured in Ohms.
Time Frame
Discharge (within 7 days of implant), 6 weeks, 3 months, 6 months, 12 months, 24 months 36 months, 48 months
Title
Presence of phrenic nerve stimulation (PNS) with the Axone 4LV lead
Description
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.
Time Frame
Implant (preferably within 15 days of enrollment), discharge (within 7 days of implant), 6 weeks, 3 months, 6 months
Title
Axone 4LV lead programming
Description
Lead programming will be reported using: (i) pacing amplitude (Volts), pulse width (milliseconds) and pacing vector(s) selected.
Time Frame
Discharge (within 7 days of implant), 6 weeks, 3 months, 6 months, 12 months, 24 months 36 months, 48 months
Title
Energy consumption associated with Axone 4LV lead
Description
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.
Time Frame
6 months
Title
Axone system-related annual complication-free rate
Description
Definition of Axone system related complication is the same as for primary safety endpoint.
Time Frame
12 months, 24 months 36 months, 48 months
Title
Clinical response to CRT at 12 months post implant
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anaïs Balland, MSc
Phone
+33602000014
Email
anais.balland@crm.microport.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric Anselme, MD
Organizational Affiliation
CHU de Rouen, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kepler Universitätsklinikum
City
Linz
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clemens Steinwender, MD
Facility Name
CH Annecy Genevois
City
Annecy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine Dompnier, MD
Facility Name
CHRU Hopital Trousseau
City
Chambray-lès-Tours
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrand Pierre, MD
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric Jean, MD
Facility Name
CHU Grenoble
City
Grenoble
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal Defaye, MD
Facility Name
CHRU de Lille - Hôpital Cardiologique
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christelle Marquié, MD
Facility Name
CHU Pontchaillou
City
Rennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Leclercq, MD
Facility Name
CHU de Rouen
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric Anselme, MD
Facility Name
CHU Toulouse
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Mondoly, MD
Facility Name
Universitätsklinikum Hamburg Eppendorf
City
Hamburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Toennis, MD
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Panagiotis Xynogalos, MD
Facility Name
Universitätsklinikum Schleswig-Holstein Campus Kiel
City
Kiel
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evgeny Lyan, MD
Facility Name
ASST Spedali Civili di Brescia
City
Brescia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Curnis, MD
Facility Name
Ospedale Pellegrini
City
Naples
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentino Ducceschi, MD
Facility Name
Ospedale Policlinico Federico II
City
Naples
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Rapacciuolo, MD
Facility Name
Isala Klinieken
City
Zwolle
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Paul Delnoy, MD
Facility Name
Centro Hospitalar Universitário Lisboa Norte - Hospital de Santa Maria
City
Lisbon
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Marques, MD
Facility Name
Centro Hospitalar Universitário do Porto
City
Porto
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hipolito Reis, MD
Facility Name
Hospital Universitario General de Alicante
City
Alicante
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Gabriel Martinez, MD
Facility Name
Hospital Universitario La Fe
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joaquin Osca, MD
Facility Name
Hospital Álvaro Cunqueiro
City
Vigo
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elvis Teijeira, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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Assessment of the Axone Micro Quadripolar Lead for Enhanced Cardiac Resynchronization Therapy

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