NCT03587064Completed
Comparison of CRT-D and CRT-DX Systems (CRT-NEXT)
Non-inferiority Randomized Clinical Investigation of CRT-DX Versus CRT-D Systems
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 640 (actual)
- First submitted
- 14 Jun 2018
- Start date
- 22 Oct 2018
- Primary completion date
- 30 Apr 2025
- Lead sponsor
- Associazione Portatori Dispositivi Impiantabili Cardiaci
- Diseases
- Heart failure
- NCT number
- NCT03587064
What you commit to
- Study type: Interventional
- Participants enrolled: 640
- From 22 Oct 2018 to the primary completion date, 30 Apr 2025
- 24 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Replacement of/upgrading from previously implanted pacing system;
Other illness
- 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;
Other
- Any indication to atrial pacing according to current guidelines;
- NYHA Class IV;
- Permanent Atrial Fibrillation
- Dialysis patients;
- Pregnant or breast-feeding women.
Who the study is looking for
- Male and female patients ≥ 18 years old
- Patients willing to participate in the investigation and signing the Patient Informed Consent (PIC) Form;
- Indication to CRT-D implant according to current ESC Guidelines on cardiac pacing and cardiac resynchronization therapy
- Sinus rhythm at time of implant;
- Optimized medical therapy according to current ESC Guidelines
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AOU Ospedali Riuniti Ancona Coordinator of this site? Confirm its status | Ancona | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Di Bologna Policlinico S. Orsola Malpighi Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Fondazione Giovanni Paolo II Coordinator of this site? Confirm its status | Campobasso | Italy | Unknown status |
| Ospedale di Camposampiero Coordinator of this site? Confirm its status | Camposampiero | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele - Presidio Ferrarotto Coordinator of this site? Confirm its status | Catania | Italy | Unknown status |
| Azienda Ospedaliera Pugliese Ciaccio Coordinator of this site? Confirm its status | Catanzaro | Italy | Unknown status |
| Clinica Sant'Anna Coordinator of this site? Confirm its status | Catanzaro | Italy | Unknown status |
| Arcispedale Sant'Anna Coordinator of this site? Confirm its status | Ferrara | Italy | Unknown status |
| Ospedale Santa Maria Nuova Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Ospedale di Gorizia Coordinator of this site? Confirm its status | Gorizia | Italy | Unknown status |
| Ospedale Vito Fazzi Coordinator of this site? Confirm its status | Lecce | Italy | Unknown status |
| Ospedale Mater Salutis Di Legnago Coordinator of this site? Confirm its status | Legnago | Italy | Unknown status |
| Ospedale Carlo Poma Coordinator of this site? Confirm its status | Mantua | Italy | Unknown status |
| IRCSS - Centro Neurolesi Bonino Pulejo Coordinator of this site? Confirm its status | Messina | Italy | Unknown status |
| Ospedale San Gerardo Coordinator of this site? Confirm its status | Monza | Italy | Unknown status |
| AOU Vanvitelli - Monaldi Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| AO dei Colli - PO Monaldi Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Ospedale Federico II Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Azienda Ospedaliero Universitaria di Parma Coordinator of this site? Confirm its status | Parma | Italy | Unknown status |
| Fondazione Toscana Gabriele Monasterio Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| Ospedale Giovanni Paolo II Coordinator of this site? Confirm its status | Ragusa | Italy | Unknown status |
| ASST Rhodense Coordinator of this site? Confirm its status | Rho | Italy | Unknown status |
| Ospedale Molinette Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Ospedali Riuniti Trieste Coordinator of this site? Confirm its status | Trieste | Italy | Unknown status |
Related publications
- Role of Atrial Pacing Support in Cardiac Resynchronization Therapy: A Noninferiority Randomized Trial.Circulation · 2026 · PMID 41910411
This page is information, not medical advice. Discuss any trial with your doctor.