Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02341768
Other study ID # RTSY03
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2015
Est. completion date November 26, 2019

Study information

Verified date August 2020
Source MicroPort CRM
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary requirement of the implantable cardioverter defibrillator (ICD) is to preserve life by terminating life-threatening arrhythmias (VT/VF). The treatment options vary in terms of techniques and medical devices, based on the patient's condition.

It is extremely important in the clinical practice to identify which patients' subgroup benefits the most from the ICD therapy, which comorbidity has a major impact on the patients' prognosis, or which pre-intra-post procedural behaviors provoke less complications, and affect the patient's outcome (including prolonged or unwanted hospitalizations).


Description:

For these reasons, it is very important to observe the clinical practice on a large variety of centers and countries, with the objective to collect long term safety and performance data in patients undergoing ICD/CRT-D device implantation (first implant, replacement or upgrade).

The safety and performance of the ICDs can be evaluated through the collection of multiple parameters such as, but not limited to:

- Clinical parameters, like patient demographics and history, procedural and hospital discharge data, as well as the short and long term serious adverse events (death and hospitalization)

- Device parameters, such as delivered shocks, ATP, or other device therapies

Worldwide selected centers will be invited to participate in this prospective study and include their "real-world" patients treated with Sorin Group commercially available ICDs and CRT-Ds devices.


Recruitment information / eligibility

Status Completed
Enrollment 2056
Est. completion date November 26, 2019
Est. primary completion date November 26, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient Implanted (first implant, replacement, upgrade) with a Sorin Group ICD/CRT-D device, according to current available guidelines and IFU

- Signed and dated informed consent (in accordance to local regulation)

Exclusion Criteria:

- Already included in another clinical study that could confound the results of this study

- Not available for routine follow-up visits

- Minor age

- Drug addiction or abuse

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ICD
ICD single, dual or triple chamber, upgrade, replacement or primo implant

Locations

Country Name City State
Austria LKH Feldkirch Feldkirchen bei Mattighofen
Austria LKH Innsbruck Innsbruck
Austria Kepler Universitatsklinikum GmbH Linz
Austria LKH St. Polten Polten
Canada Royal Alexandra Hospital Edmonton
Canada HDM (CHUM) Montreal Montreal
Canada HSCM Montreal Montreal
Canada IUCPQ Quebec Quebec
Canada Sherbrooke Quebec
Canada Sunnybrook Health Sciences Center Toronto Ontario
Czechia Fakultni Nemocnice Brno Brno
Czechia Fakultni Nemocnice U svaté Anny v Brno Brno
Czechia Fakultni Nemocnice Olomouc Olomouc
France CHU Angers Angers
France CH Annecy Genevois Annecy
France Clinique Rhône Durance Avignon
France CHU de Bordeaux Bordeaux
France CHU de Brest Brest
France CHU de Caen Caen
France H.I.A Percy Clamart
France CHU de Clermont-Ferrand Clermont-Ferrand
France CHU Henri Mondor Créteil
France CHU de Grenoble Grenoble
France CH de Marne la Vallée Jossigny
France Hôpital Louis Pasteur Le Coudray
France CHRU de Lille Lille
France CH St Joseph St Luc Lyon
France Hôpital la Timone Marseille
France Hôpital Nord Marseille Marseille
France Hôpital Jacques Cartier Massy
France CHU A de Villeneuve Montpellier
France Clinique du Millénaire Montpellier
France CHRU de Nancy Nancy
France CHU de Nantes Nantes
France Nouvelles Cliniques Nantaises Nantes
France CHU de Nimes Nimes
France La Pitié Salpétrière Paris
France HEGP Paris 15
France CHU François Mitterand Pau
France CH Perpignan Perpignan
France CHU de Poitiers Poitiers
France CHRU de Pontchaillou Rennes
France CHRU de Rouen Rouen
France CHU de Valence Valence
France CH de Villefranche sur Saone Villefranche sur Saone
Germany Kardiologische Praxis Altentreptow
Germany HGZ Bad Bevensen Bad Bevensen
Germany Herz- und Diabeteszentrum Bad Oeynhausen
Germany Evangelisches Krankenhaus Bielefeld
Germany Universitatskliniken Bonn
Germany Kardiologie Darmstadt Darmstadt
Germany Universitatskliniken Düsseldorf Düsseldorf
Germany Albertinen-Krankenhaus Hamburg
Germany Cardiologicum Hamburg Hamburg
Germany Universität Kiel Kiel
Germany Universitaetsklinikum Schleswig Holstein Lubeck
Germany Universitätsklinikum Magdeburg Magdeburg
Germany Kardiologische Praxis Markkleeberg
Germany Dietrich Bonhoeffer Klinikum Neubrandenburg
Germany Universitatsklinikum Wurzburg
Italy Ospedale Garibaldi Centro Catania
Italy Ospedale Pol SS Annunziata Chieti
Italy Presidio Ospedaliero di Chioggia Chioggia
Italy Ospital San Luca Lucca
Italy Ospedale Civile Mirano
Italy Osp S Giovanni Bosco Napoli
Italy Ospedale Cardarelli Napoli
Italy Ospedale Policlinico Federico II Napoli
Italy Policlinico Casilino Rome
Italy Osp. G. Mazzini Teramo
Italy Azienda Ospedaliero-Universitaria Ospedali Riuniti Trieste
Netherlands Vlietland Ziekenhuis Schiedam
Netherlands Isala Klinieken Zwolle
Portugal Hospital Garcia de Orta Almada
Portugal Hospital Professor Doutor Fernando Fonseca Amadora
Portugal CHLC Hospital de Santa Marta Lisboa
Portugal H. Santa Maria Lisboa
Slovakia Susch Hospital Banská Bystrica
Slovakia Nusch Hospital Bratislava
Slovakia Vusch Hospital Kosice
Spain Hospital Clínic de Barcelona Barcelona
Spain Hospital Virgen de las Nieves Granada
Spain Hospital Ramon y Cajal Madrid
Spain Hospital Universitario Clínico San Carlos Madrid
Spain Hospital Universitario Puerta de Hierro Majadahonda
Spain Hospital Universitario Virgen de la Victoria Malaga
Spain Hospital Central de Asturias Oviedo
Spain Hospital Son Llàtzer Palma de Mallorca
Spain Complejo Hospitalario Universitario Santiago de Compostela
Spain H.U La Fe Valencia
Spain CHU de Vigo Vigo
Switzerland Fondazione Cardiocentro Ticino Lugano
United Kingdom Barnet General Hospital Barnet
United Kingdom Edgbaston Birmingham
United Kingdom Papworth Hospital NHS Foundation Trust Cambridge
United Kingdom Dorget County Hospital Dorchester
United Kingdom Royal Infirmary of Edinburgh Edinburgh
United Kingdom Wye Valley NHS Trust Hereford
United Kingdom Glenfield Hospital Leicester
United Kingdom King's College Hospital London
United Kingdom Northampton General Hospital Northampton
United Kingdom Northern General Hospital Sheffield

Sponsors (1)

Lead Sponsor Collaborator
MicroPort CRM

Countries where clinical trial is conducted

Austria,  Canada,  Czechia,  France,  Germany,  Italy,  Netherlands,  Portugal,  Slovakia,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate clinical and device functional information from "real world" ICD patient population following standard of care at participating centers w/in the different participating countries (Incidence of all death, device,cardiac related hospitalization) Incidence of all death, device and/or cardiac related hospitalization at 24 months post implant 2 years
Secondary Serious procedural complications or other SAE at implantation or hospital discharge. The data analyzed are those collected from the day of implantation to the day of hospital discharge, with an expected average of 1 week. as reported by the sites on the AE eCRF at implantation or hospital discharge
Secondary The incidence of all death, device and/or cardiac related hospitalization at 12 months post implant (evaluated with a survival curve) as reported by the sites with AE at 12 months
Secondary The predictors of mortality and cardiac related hospitalization at 12 and 24 months as reported by the sites with AE and medical history information at 12 and 24 months
Secondary The predictors of appropriate or inappropriate therapies (ATP and shocks) at 12 and 24 months, as verified by a dedicated committee based on therapies delivered recorder on device file, and verified by a dedicated committee at 12 and 24 months
Secondary The evolution of the indication for implant according to guideline (based on the patient's medical history and reason for implant as reported by the investigators) based on the patient's medical history and reason for implant as reported by the investigators at implant
See also
  Status Clinical Trial Phase
Completed NCT00376532 - Extracellular Matrix Marker of Arrhythmia Risk (EMMA) N/A
Recruiting NCT04848844 - The PAtients pResenTing With COngenital HeaRt DIseAse Register (ARTORIA-R)
Completed NCT06039397 - The Effect of Semi Fowler 30' Right Lateral on Cardiac Output in Acute Heart Failure N/A
Completed NCT04025762 - 24/7 Closed-loop in Older Subjects With Type 1 Diabetes N/A
Not yet recruiting NCT03619018 - All Inclusive KODEX - EPD™ Study Patient Specific Optimized Therapy (PSOT) Study
Completed NCT03786640 - Abbott Brady 3T MRI PMCF
Recruiting NCT05935007 - Aveir DR Real-World Evidence Post-Approval Study
Recruiting NCT05932602 - AVEIR DR Coverage With Evidence Development (CED) Study
Recruiting NCT01988064 - Face to Face vs. Group Training Methods on Pulse Rate Taking in Patients With Cardiovascular Diseases. N/A
Recruiting NCT06310707 - Arrhythmia Identification in Syncope Patients: ePatch® Versus 24h Holter N/A
Terminated NCT03481413 - Patient Specific Optimized Therapy Post-Market Clinical Follow-up Study
Recruiting NCT05443321 - Advancing Health Information Exchange (HIE) During Inter-hospital Transfer (IHT) to Improve Patient Outcomes N/A
Recruiting NCT03801681 - ARrhythmias in MYocarditis
Completed NCT03628534 - SERF VT Ablation Early Feasibility Study (EFS) N/A
Recruiting NCT05034432 - The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients Phase 4
Recruiting NCT04856267 - Exploration of Arrhythmia Burden in Cardiac Amyloidosis Using Implantable Loop Recorders
Not yet recruiting NCT06414447 - Electrocardiogram (ECG) Validation Study
Completed NCT02401659 - Importance of Patient´s Satisfaction With Telemedicine Based on Monitoring Systems N/A
Recruiting NCT05790642 - Comparison of Different Non-invasive Methods to Assess Pulse Wave Analysis
Recruiting NCT04833712 - Stereotactic Radioablation for the Treatment of Refractory Atrial Fibrillation N/A