Safety and Performance of INVICTA Ventricular DF4 LEADS With Active Fixation-(APOLLO) (APOLLO)

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure; Ventricular Arrythmia; ICD; Lead
• Intervention / Treatment: Device: INVICTA lead

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

• Study Type: Interventional
• Enrollment (Actual): 446
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Lisbon, Portugal
    • Hospital Santa Maria
• Spain
  • Alicante, Spain
    • Hospital General de Alicante
  • Girona, Spain
    • Hospital Josep Trueta,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Any patient presenting an ICD or CRT-D indication as detailed in the latest ESC guidelines
2. Scheduled for a de-novo implant of an ICD (VR, DR) or CRT-D, manufactured by MicroPort CRM and equipped with a DF4 connector
3. Signed and dated informed consent

Exclusion Criteria:

1. Tricuspid valvular disease or any type of tricuspid replacement heart valve (mechanical or tissue)
2. Transient tachyarrhythmias due to reversible causes (such as drug intoxication, electrolyte imbalance, sepsis, hypoxia or other factors as myocardial infarction or electric shock)
3. Contraindication to a maximum single dose of 330 µg dexamethasone sodium phosphate (DSP)
4. Active myocarditis
5. Previous implant of pacemaker, ICD or CRT-D device and leads
6. Currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study
7. 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
8. Minor subjects
9. Pre-menopausal women
10. Drug addiction or abuse
11. Life expectancy less than 1 year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INVICTA lead; All patients eligible for enrolment in whom the INVICTA lead is attempted (Implant of the INVICTA lead	Device: INVICTA lead; The implant or the attempt to implant an INVICTA lead; Other Names: Implant of the INVICTA lead

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	90 days
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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
INVICTA lead pacing threshold	RV lead pacing threshold amplitude (V), measured by the implanted ICD/CRT-D with 0.5 ms pulse width	24 months
INVICTA lead impedances	RV lead pacing impedance (Ohm) and defibrillation coil impedance (Ohm), measured by the implanted ICD/CRT-D	24 months
INVICTA sensing threshold	RV lead endocardial R wave amplitude (mV), measured by the implanted ICD/CRT-D	24 months
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	24 months
Acute INVICTA lead complications	Assessment of Acute INVICTA lead complications	30 days
Chronic INVICTA lead complications	Assessment of Chronic INVICTA lead complications	> 30 days
Daily INVICTA autothreshold values (V)	Assessment of Daily INVICTA autothreshold values (V)	1 month
.INVICTA lead handling assessment	Summary of the investigators' opinion about INVICTA handling at implant	At implant (day 0)
INVICTA lead implant success rate	% of enrolled patients successfully implanted with an INVICTA lead	At implant (day 0)
Serious Adverse Events up to 24 months	Report of SAEs occurred up to 24 months post-implantation	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute complication rates as a function of the lead position	Acute complication rates as a function of the lead position (apical vs septal)	< 30 days
Chronic complication rates as a function of the lead position	Chronic complication rates as a function of the lead position (apical vs septal	> 30 days
Electrical performances as a function of the lead position	Electrical performances as a function of the lead position (apical vs septal)	24 months

Collaborators and Investigators

• Sponsor: MicroPort CRM
• Investigators: Principal Investigator: Pedro MARQUES, MD, Hospital de Santa Maria - Lisboa - Portugal

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2021
• Primary Completion (Actual): March 16, 2022
• Study Completion (Anticipated): September 10, 2025

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: LINI01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No