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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)
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INVICTA lead | Experimental | All patients eligible for enrolment in whom the INVICTA lead is attempted (Implant of the INVICTA lead |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INVICTA lead | Device | The implant or the attempt to implant an INVICTA lead |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedro Marques, MD | Hospital de Santa Maria - Lisboa - Portugal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kepler Universitätsklinikum GmbH | Linz | Austria | ||||
| CH Annecy |
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INVICTA lead
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| 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 |
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 |
| Annecy |
| France |
| CHU Brest | Brest | France |
| CHU Clermont- Ferrand | Clermont-Ferrand | France |
| CHU Grenoble | Grenoble | France |
| CHU Lille | Lille | France |
| Hôpital St Joseph | Marseille | France |
| CHU Strasbourg | Strasbourg | France |
| CHU Tours | Tours | France |
| RWTH Aachen | Aachen | Germany |
| Herz- und Gefäßzentrum Bad Bevensen | Bad Bevensen | Germany |
| Evangelisches Klinikum Bethel | Bielefeld | Germany |
| Universitäts- Herzzentrum Freiburg -Bad Krozingen | Freiburg im Breisgau | Germany |
| Hausärztlich- Kardiologisches MVZ "Am Felsenkeller" GmbH | Pirna | Germany |
| Cliniche Humanitas Gavazzeni | Bergamo | Italy |
| Ospedale di Desenzano del Garda | Desenzano del Garda | Italy |
| Ospedale Piemonte (IRCCS Bonino Pulejo) | Messina | Italy |
| AO di Rilievo Nazionale A. Cardarelli | Naples | Italy |
| Univ. degli Studi della Campania L. Vanvitelli | Naples | Italy |
| Osp SS Annunziata | Taranto | Italy |
| AO Univ. S. Maria della Misericordia | Udine | Italy |
| AULSS 8 Berica - Vicenza | Vicenza | Italy |
| Elisabeth Tweesteden Ziekenhuis | Tilburg | Netherlands |
| Isala Klinieken | Zwolle | Netherlands |
| ULS Amadora/Sintra | Amadora | Portugal |
| ULS de Coimbra | Coimbra | Portugal |
| ULS do Alto Ave | Creixomil | Portugal |
| ULS Alentejo Central | Evora | Portugal |
| Hospital Santa Maria | Lisbon | Portugal |
| ULS de Sao Jose - Hospital Santa Marta | Lisbon | Portugal |
| ULS Santo Antonio | Porto | Portugal |
| ULS Gaia/Espinho | Vila Nova de Gaia | Portugal |
| Hospital Clínico Universitario de Valencia | Valencia | Spain | Spain |
| Hospital General de Alicante | Alicante | Spain |
| Hospital Josep Trueta, | Girona | Spain |
| Hospital Virgen de las Nieves | Granda | Spain |
| Hospital Universitario de Gran Canaria | Las Palmas | Spain |
| Hospital Clinico de Madrid | Madrid | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | Spain |
| Hospital General Universitario de Valencia | Valencia | Spain |
| Hospital Universitario y Politécnico La Fe | Valencia | Spain |
| Barnet Hospital, Royal Free Trust | Barnet | United Kingdom |
| Queen Elizabeth | Birmingham | United Kingdom |
| Great Western Hospital | Swindon | United Kingdom |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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