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Comparison of CRT-D and CRT-DX Systems (CRT-NEXT)
Sponsor: Associazione Portatori Dispositivi Impiantabili Cardiaci
Summary
The principal objective is to test non-inferiority of the CRT-DX system as compared to a conventional CRT-D system, in terms of the combined endpoint of mortality, hospitalizations due cardiovascular causes, any complication leading to loss of lead functionality, in the subset of patients without evidence of sinus dysfunction on optimal therapy.
Official title: Non-inferiority Randomized Clinical Investigation of CRT-DX Versus CRT-D Systems
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
640
Start Date
2018-10-22
Completion Date
2025-05-07
Last Updated
2026-07-06
Healthy Volunteers
No
Interventions
Conventional 3-lead CRT defibrillator system implantation
Conventional 3-lead(1 atrial and 2 ventricular leads) system implantation
2-lead CRT defibrillator system implantation
2-lead (2 ventricular leads with dipole for atrial sensing) DX system implantation
Locations (24)
AOU Ospedali Riuniti Ancona
Ancona, Ancona, Italy
Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi
Bologna, Bologna, Italy
Fondazione Giovanni Paolo II
Campobasso, Campobasso, Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele - Presidio Ferrarotto
Catania, Catania, Italy
Clinica Sant'Anna
Catanzaro, Catanzaro, Italy
Azienda Ospedaliera Pugliese Ciaccio
Catanzaro, Catanzaro, Italy
Arcispedale Sant'Anna
Ferrara, Ferrara, Italy
Ospedale Santa Maria Nuova
Florence, Firenze, Italy
Ospedale di Gorizia
Gorizia, Gorizia, Italy
Ospedale Vito Fazzi
Lecce, Lecce, Italy
Ospedale Carlo Poma
Mantua, Mantova, Italy
IRCSS - Centro Neurolesi Bonino Pulejo
Messina, Messina, Italy
ASST Rhodense
Rho, Milano, Italy
Ospedale San Gerardo
Monza, Monza, Italy
AOU Vanvitelli - Monaldi
Naples, Napoli, Italy
AO dei Colli - PO Monaldi
Naples, Napoli, Italy
Ospedale Federico II
Naples, Napoli, Italy
Ospedale di Camposampiero
Camposampiero, Padova, Italy
Azienda Ospedaliero - Universitaria di Parma
Parma, Parma, Italy
Fondazione Toscana Gabriele Monasterio
Pisa, Pisa, Italy
Ospedale Giovanni Paolo II
Ragusa, Ragusa, Italy
Ospedale Molinette
Torino, Torino, Italy
Ospedali Riuniti Trieste
Trieste, Trieste, Italy
Ospedale Mater Salutis di Legnago
Legnago, Italy