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

Not Applicable

Active, not recruiting

• Conditions: Ventricular Arrythmia; Lead; Heart Failure; ICD
• Interventions: Device: INVICTA lead

• Registration Number: NCT04590144
• Lead Sponsor: MicroPort CRM

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

Study Timeline

• Study First Submitted: 2020-10-09
• Study First Submitted QC: 2020-10-09
• Study First Posted: 2020-10-19
• Study Start: 2021-06-04
• Primary Completion: 2022-03-16
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-30
• Last Update Posted: 2022-12-01
• Study Completion: 2025-09-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 446

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
INVICTA lead	INVICTA lead	All patients eligible for enrolment in whom the INVICTA lead is attempted (Implant of the INVICTA lead

Primary Outcome Measures

Name	Time	Method
1.Freedom from INVICTA lead-related complications 1.Freedom from INVICTA lead-related complications [Time Frame: 90 days	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	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

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

Trial Locations

Locations (3)

Hospital Santa Maria; 🇵🇹 Lisbon, Portugal

Hospital Josep Trueta,; 🇪🇸 Girona, Spain

Hospital General de Alicante; 🇪🇸 Alicante, Spain