Back to resultsSafety and Performance of INVICTA Ventricular DF4 LEADS With Active Fixation-(APOLLO) (APOLLO)
Primary Purpose
Ventricular Arrythmia, Lead, ICD
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
INVICTA lead
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Arrythmia
Eligibility Criteria
Inclusion Criteria:
- Any patient presenting an ICD or CRT-D indication as detailed in the latest ESC guidelines
- Scheduled for a de-novo implant of an ICD (VR, DR) or CRT-D, manufactured by MicroPort CRM and equipped with a DF4 connector
- Signed and dated informed consent
Exclusion Criteria:
- Tricuspid valvular disease or any type of tricuspid replacement heart valve (mechanical or tissue)
- Transient tachyarrhythmias due to reversible causes (such as drug intoxication, electrolyte imbalance, sepsis, hypoxia or other factors as myocardial infarction or electric shock)
- Contraindication to a maximum single dose of 330 µg dexamethasone sodium phosphate (DSP)
- Active myocarditis
- Previous implant of pacemaker, ICD or CRT-D device and leads
- Currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study
- Incapacitated subject or under guardianship, inability to understand the purpose of the study, or to meet follow-up visits at the implanting centre as defined in the investigational plan
- Minor subjects
- Pre-menopausal women
- Drug addiction or abuse
- Life expectancy less than 1 year
Sites / Locations
- Hospital Santa Maria
- Hospital General de Alicante
- Hospital Josep Trueta,
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
INVICTA lead
Arm Description
All patients eligible for enrolment in whom the INVICTA lead is attempted (Implant of the INVICTA lead
Outcomes
Primary Outcome Measures
1.Freedom from INVICTA lead-related complications 1.Freedom from INVICTA lead-related complications [Time Frame: 90 days
Freedom from INVICTA lead-related complications as assessed by an independent events adjudicator and defined as any INVICTA lead-related serious adverse device effect (SADE) that resulted in patient death or required an additional invasive intervention
2.INVICTA lead electrical performance at 3 months
Right Ventricular (RV) pacing threshold (V) of the INVICTA lead, measured by the implanted ICD/CRT-D with 0.5 ms pulse width
Secondary Outcome Measures
INVICTA lead pacing threshold
RV lead pacing threshold amplitude (V), measured by the implanted ICD/CRT-D with 0.5 ms pulse width
INVICTA lead impedances
RV lead pacing impedance (Ohm) and defibrillation coil impedance (Ohm), measured by the implanted ICD/CRT-D
INVICTA sensing threshold
RV lead endocardial R wave amplitude (mV), measured by the implanted ICD/CRT-D
Percentage of the shocks that successfully terminate a ventricular arrhythmia episode
Percentage of endocardial shock therapies that successfully terminate ventricular arrhythmia episodes, calculated as the proportion of successful shocks on the total number of shocks delivered during defibrillation testing or spontaneous ventricular arrhythmias
Acute INVICTA lead complications
Assessment of Acute INVICTA lead complications
Chronic INVICTA lead complications
Assessment of Chronic INVICTA lead complications
Daily INVICTA autothreshold values (V)
Assessment of Daily INVICTA autothreshold values (V)
.INVICTA lead handling assessment
Summary of the investigators' opinion about INVICTA handling at implant
INVICTA lead implant success rate
% of enrolled patients successfully implanted with an INVICTA lead
Serious Adverse Events up to 24 months
Report of SAEs occurred up to 24 months post-implantation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04590144
Brief Title
Safety and Performance of INVICTA Ventricular DF4 LEADS With Active Fixation-(APOLLO)
Acronym
APOLLO
Official Title
Safety and Performance of INVICTA Ventricular DF4 LEADS With Active Fixation-(APOLLO)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 4, 2021 (Actual)
Primary Completion Date
March 16, 2022 (Actual)
Study Completion Date
September 10, 2025 (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
No
5. Study Description
Brief Summary
The primary objective of this study is to assess the safety and key electrical performance of the INVICTA leads equipped with DF4 connector: ACTIVE fixation type models (single and dual coil: INVICTA 1CR, INVICTA 2CR)
Detailed Description
APOLLO study is a pre-market approval (INVICTA leads - devices under investigation - are not CE marked), interventional, prospective, longitudinal, international (European), multicenter, single arm study.
The devices under investigation, the INVICTA defibrillation leads, are new quadripolar leads, to be used with Implantable Cardiac Defibrillators and Cardiac Resynchronization Therapy Defibrillators (ICD/CRT-D).
This clinical study intends to demonstrate safety and electrical performances of the INVICTA leads among the different models: active fixation either single coil (model 1CR) or dual coil (model 2CR)leads models. The clinical data will be used to support the application to CE marking of INVICTA leads.
The primary endpoints will be evaluated at 3 months post-implantation; secondary endpoints will be evaluated up to 2 years post-implantation.
A total number of 445 patients will be enrolled in the study, in up to 60 centers in Europe.
The follow-up visits are scheduled at hospital discharge, at 1 month, at 3 months, at 6 months, at 12 months, at 18 months and at 24 months, post-implant
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Arrythmia, Lead, ICD, Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
INVICTA lead
Masking
None (Open Label)
Allocation
N/A
Enrollment
446 (Actual)
8. Arms, Groups, and Interventions
Arm Title
INVICTA lead
Arm Type
Experimental
Arm Description
All patients eligible for enrolment in whom the INVICTA lead is attempted (Implant of the INVICTA lead
Intervention Type
Device
Intervention Name(s)
INVICTA lead
Other Intervention Name(s)
Implant of the INVICTA lead
Intervention Description
The implant or the attempt to implant an INVICTA lead
Primary Outcome Measure Information:
Title
1.Freedom from INVICTA lead-related complications 1.Freedom from INVICTA lead-related complications [Time Frame: 90 days
Description
Freedom from INVICTA lead-related complications as assessed by an independent events adjudicator and defined as any INVICTA lead-related serious adverse device effect (SADE) that resulted in patient death or required an additional invasive intervention
Time Frame
90 days
Title
2.INVICTA lead electrical performance at 3 months
Description
Right Ventricular (RV) pacing threshold (V) of the INVICTA lead, measured by the implanted ICD/CRT-D with 0.5 ms pulse width
Time Frame
3 months
Secondary Outcome Measure Information:
Title
INVICTA lead pacing threshold
Description
RV lead pacing threshold amplitude (V), measured by the implanted ICD/CRT-D with 0.5 ms pulse width
Time Frame
24 months
Title
INVICTA lead impedances
Description
RV lead pacing impedance (Ohm) and defibrillation coil impedance (Ohm), measured by the implanted ICD/CRT-D
Time Frame
24 months
Title
INVICTA sensing threshold
Description
RV lead endocardial R wave amplitude (mV), measured by the implanted ICD/CRT-D
Time Frame
24 months
Title
Percentage of the shocks that successfully terminate a ventricular arrhythmia episode
Description
Percentage of endocardial shock therapies that successfully terminate ventricular arrhythmia episodes, calculated as the proportion of successful shocks on the total number of shocks delivered during defibrillation testing or spontaneous ventricular arrhythmias
Time Frame
24 months
Title
Acute INVICTA lead complications
Description
Assessment of Acute INVICTA lead complications
Time Frame
30 days
Title
Chronic INVICTA lead complications
Description
Assessment of Chronic INVICTA lead complications
Time Frame
> 30 days
Title
Daily INVICTA autothreshold values (V)
Description
Assessment of Daily INVICTA autothreshold values (V)
Time Frame
1 month
Title
.INVICTA lead handling assessment
Description
Summary of the investigators' opinion about INVICTA handling at implant
Time Frame
At implant (day 0)
Title
INVICTA lead implant success rate
Description
% of enrolled patients successfully implanted with an INVICTA lead
Time Frame
At implant (day 0)
Title
Serious Adverse Events up to 24 months
Description
Report of SAEs occurred up to 24 months post-implantation
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Acute complication rates as a function of the lead position
Description
Acute complication rates as a function of the lead position (apical vs septal)
Time Frame
< 30 days
Title
Chronic complication rates as a function of the lead position
Description
Chronic complication rates as a function of the lead position (apical vs septal
Time Frame
> 30 days
Title
Electrical performances as a function of the lead position
Description
Electrical performances as a function of the lead position (apical vs septal)
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Any patient presenting an ICD or CRT-D indication as detailed in the latest ESC guidelines
Scheduled for a de-novo implant of an ICD (VR, DR) or CRT-D, manufactured by MicroPort CRM and equipped with a DF4 connector
Signed and dated informed consent
Exclusion Criteria:
Tricuspid valvular disease or any type of tricuspid replacement heart valve (mechanical or tissue)
Transient tachyarrhythmias due to reversible causes (such as drug intoxication, electrolyte imbalance, sepsis, hypoxia or other factors as myocardial infarction or electric shock)
Contraindication to a maximum single dose of 330 µg dexamethasone sodium phosphate (DSP)
Active myocarditis
Previous implant of pacemaker, ICD or CRT-D device and leads
Currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study
Incapacitated subject or under guardianship, inability to understand the purpose of the study, or to meet follow-up visits at the implanting centre as defined in the investigational plan
Minor subjects
Pre-menopausal women
Drug addiction or abuse
Life expectancy less than 1 year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Marques, MD
Organizational Affiliation
Hospital de Santa Maria - Lisboa - Portugal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Santa Maria
City
Lisbon
Country
Portugal
Facility Name
Hospital General de Alicante
City
Alicante
Country
Spain
Facility Name
Hospital Josep Trueta,
City
Girona
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Safety and Performance of INVICTA Ventricular DF4 LEADS With Active Fixation-(APOLLO)
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