Could a simpler heart device be just as effective?
NCT ID NCT03587064
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This trial tests whether a newer, simpler 2-lead cardiac resynchronization therapy defibrillator (CRT-DX) works as well as the standard 3-lead system (CRT-D) in people with heart failure. The study includes 640 adults who need a CRT-D and have a normal heart rhythm. The main goal is to compare rates of death, heart-related hospital stays, and lead complications between the two devices.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- 2-lead CRT defibrillator system (CRT-DX)
- What this could lead to
- If successful, this could show that a simpler, 2-lead defibrillator works as well as the standard 3-lead version, potentially making implantation easier and reducing complications.
- What could go wrong
- This is a non-inferiority trial, meaning it aims to prove the simpler device is not worse, not that it is better. The results may not apply to all heart failure patients, and there is always a risk of device-related complications.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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AO dei Colli - PO Monaldi
Naples, Napoli, Italy
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AOU Ospedali Riuniti Ancona
Ancona, Ancona, Italy
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AOU Vanvitelli - Monaldi
Naples, Napoli, 88100, Italy
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ASST Rhodense
Rho, Milano, Italy
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Arcispedale Sant'Anna
Ferrara, Ferrara, 44124, Italy
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Azienda Ospedaliera Pugliese Ciaccio
Catanzaro, Catanzaro, Italy
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Azienda Ospedaliero - Universitaria di Parma
Parma, Parma, 43126, Italy
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Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele - Presidio Ferrarotto
Catania, Catania, Italy
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Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi
Bologna, Bologna, Italy
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Clinica Sant'Anna
Catanzaro, Catanzaro, 88100, Italy
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Fondazione Giovanni Paolo II
Campobasso, Campobasso, Italy
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Fondazione Toscana Gabriele Monasterio
Pisa, Pisa, Italy
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IRCSS - Centro Neurolesi Bonino Pulejo
Messina, Messina, 98124, Italy
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Ospedale Carlo Poma
Mantua, Mantova, Italy
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Ospedale Federico II
Naples, Napoli, Italy
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Ospedale Giovanni Paolo II
Ragusa, Ragusa, 97100, Italy
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Ospedale Mater Salutis di Legnago
Legnago, Italy
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Ospedale Molinette
Torino, Torino, 10126, Italy
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Ospedale San Gerardo
Monza, Monza, Italy
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Ospedale Santa Maria Nuova
Florence, Firenze, 50122, Italy
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Ospedale Vito Fazzi
Lecce, Lecce, Italy
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Ospedale di Camposampiero
Camposampiero, Padova, 35012, Italy
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Ospedale di Gorizia
Gorizia, Gorizia, 34170, Italy
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Ospedali Riuniti Trieste
Trieste, Trieste, Italy
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