Clinical trial NCT04590144: Safety and Performance of INVICTA Ventricular DF4 LEADS With Active Fixation-(APOLLO)
Official title: Safety and Performance of INVICTA Ventricular DF4 LEADS With Active Fixation-(APOLLO)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ventricular Arrythmia
Lead
ICD
Heart Failure
Lead sponsor: MicroPort CRM
Sponsor class: INDUSTRY
First posted: 2020-10-19
Enrollment: 446
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: INVICTA lead
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: 1.Freedom from INVICTA lead-related complications 1.Freedom from INVICTA lead-related complications [Time Frame: 90 days
timeFrame: 90 days
measure: 2.INVICTA lead electrical performance at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: INVICTA lead pacing threshold
timeFrame: 24 months
measure: INVICTA lead impedances
timeFrame: 24 months
measure: INVICTA sensing threshold
timeFrame: 24 months
measure: Percentage of the shocks that successfully terminate a ventricular arrhythmia episode
timeFrame: 24 months
measure: Acute INVICTA lead complications
timeFrame: 30 days
measure: Chronic INVICTA lead complications
timeFrame: > 30 days
measure: Daily INVICTA autothreshold values (V)
timeFrame: 1 month
measure: .INVICTA lead handling assessment
timeFrame: At implant (day 0)
measure: INVICTA lead implant success rate
timeFrame: At implant (day 0)
measure: Serious Adverse Events up to 24 months
timeFrame: 24 months
Other outcomes:
measure: Acute complication rates as a function of the lead position
timeFrame: < 30 days
measure: Chronic complication rates as a function of the lead position
timeFrame: > 30 days
measure: Electrical performances as a function of the lead position
timeFrame: 24 months
Locations:
city: Lisbon
country: Portugal
facility: Hospital Santa Maria
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Girona
country: Spain
facility: Hospital Josep Trueta,
Study officials:
affiliation: Hospital de Santa Maria - Lisboa - Portugal
name: Pedro Marques, MD
role: PRINCIPAL_INVESTIGATOR
References: