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Could a simpler heart device be just as effective?

NCT ID NCT03587064

Disease control Sponsor: Associazione Portatori Dispositivi Impiantabili Cardiaci Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

640 people

The number who actually took part.

Started

Oct 2018

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male and female patients ≥ 18 years old 2. Patients willing to participate in the investigation and signing the Patient Informed Consent (PIC) Form; 3. Indication to CRT-D implant according to current ESC Guidelines on cardiac pacing and cardiac resynchronization therapy 4. Sinus rhythm at time of implant; 5. Optimized medical therapy according to current ESC Guidelines 6. Rest heart rate (HR) \>45 bpm at baseline ECG, with betablocker therapy at optimal medical dosage; or, if rest HR\<45 bpm: maximum heart rate at the 6- minute walking test \>85 bpm. Exclusion Criteria: 1. Any indication to atrial pacing according to current guidelines; 2. Both: resting heart rate \<45 bpm at baseline ECG, with betablocker therapy at optimal medical dosage and maximum heart rate at the 6-minute walking test \<85 bpm; 3. NYHA Class IV; 4. Permanent Atrial Fibrillation 5. Replacement of/upgrading from previously implanted pacing system; 6. Dialysis patients; 7. Pregnant or breast-feeding women.

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac resynchronization therapy Heart failure

Contacts and locations

Locations

  • AO dei Colli - PO Monaldi

    Naples, Napoli, Italy

  • AOU Ospedali Riuniti Ancona

    Ancona, Ancona, Italy

  • AOU Vanvitelli - Monaldi

    Naples, Napoli, 88100, Italy

  • ASST Rhodense

    Rho, Milano, Italy

  • Arcispedale Sant'Anna

    Ferrara, Ferrara, 44124, Italy

  • Azienda Ospedaliera Pugliese Ciaccio

    Catanzaro, Catanzaro, Italy

  • Azienda Ospedaliero - Universitaria di Parma

    Parma, Parma, 43126, Italy

  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele - Presidio Ferrarotto

    Catania, Catania, Italy

  • Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi

    Bologna, Bologna, Italy

  • Clinica Sant'Anna

    Catanzaro, Catanzaro, 88100, Italy

  • Fondazione Giovanni Paolo II

    Campobasso, Campobasso, Italy

  • Fondazione Toscana Gabriele Monasterio

    Pisa, Pisa, Italy

  • IRCSS - Centro Neurolesi Bonino Pulejo

    Messina, Messina, 98124, Italy

  • Ospedale Carlo Poma

    Mantua, Mantova, Italy

  • Ospedale Federico II

    Naples, Napoli, Italy

  • Ospedale Giovanni Paolo II

    Ragusa, Ragusa, 97100, Italy

  • Ospedale Mater Salutis di Legnago

    Legnago, Italy

  • Ospedale Molinette

    Torino, Torino, 10126, Italy

  • Ospedale San Gerardo

    Monza, Monza, Italy

  • Ospedale Santa Maria Nuova

    Florence, Firenze, 50122, Italy

  • Ospedale Vito Fazzi

    Lecce, Lecce, Italy

  • Ospedale di Camposampiero

    Camposampiero, Padova, 35012, Italy

  • Ospedale di Gorizia

    Gorizia, Gorizia, 34170, Italy

  • Ospedali Riuniti Trieste

    Trieste, Trieste, Italy

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