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

Heart Failure Clinical Trial

— APOLLO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04590144
• Other study ID #: LINI01
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 4, 2021
• Est. completion date: September 10, 2025

Study information

• Verified date: November 2022
• Source: MicroPort CRM
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 446
• Est. completion date: September 10, 2025
• Est. primary completion date: March 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• ICD
• Lead
• Ventricular Arrythmia

Intervention

Device:
• INVICTA lead
The implant or the attempt to implant an INVICTA lead

Locations

Country	Name	City	State
Portugal	Hospital Santa Maria	Lisbon
Spain	Hospital General de Alicante	Alicante
Spain	Hospital Josep Trueta,	Girona

Sponsors (1)

Lead Sponsor	Collaborator
MicroPort CRM

Countries where clinical trial is conducted

Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Electrical performances as a function of the lead position	Electrical performances as a function of the lead position (apical vs septal)	24 months
Primary	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
Primary	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	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
Secondary	INVICTA lead impedances	RV lead pacing impedance (Ohm) and defibrillation coil impedance (Ohm), measured by the implanted ICD/CRT-D	24 months
Secondary	INVICTA sensing threshold	RV lead endocardial R wave amplitude (mV), measured by the implanted ICD/CRT-D	24 months
Secondary	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
Secondary	Acute INVICTA lead complications	Assessment of Acute INVICTA lead complications	30 days
Secondary	Chronic INVICTA lead complications	Assessment of Chronic INVICTA lead complications	> 30 days
Secondary	Daily INVICTA autothreshold values (V)	Assessment of Daily INVICTA autothreshold values (V)	1 month
Secondary	.INVICTA lead handling assessment	Summary of the investigators' opinion about INVICTA handling at implant	At implant (day 0)
Secondary	INVICTA lead implant success rate	% of enrolled patients successfully implanted with an INVICTA lead	At implant (day 0)
Secondary	Serious Adverse Events up to 24 months	Report of SAEs occurred up to 24 months post-implantation	24 months