Comparison of CRT-D and CRT-DX Systems (CRT-NEXT)
CRT-NEXT
Non-inferiority Randomized Clinical Investigation of CRT-DX Versus CRT-D Systems
1 other identifier
interventional
640
1 country
24
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started Oct 2018
Longer than P75 for not_applicable heart-failure
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2018
CompletedFirst Posted
Study publicly available on registry
July 16, 2018
CompletedStudy Start
First participant enrolled
October 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedNovember 15, 2023
November 1, 2023
6.4 years
June 14, 2018
November 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Combined endpoint of Mortality, hospitalization due to cardiac causes and lead-related complications
It includes number of patients who experienced death, hospitalization due to cardiac causes, or any lead-related complication leading to loss of functionality (including lead dislodgement, conduction or insulation failure, loss of sensing or capture that couldn't resolved by reprogramming)
1 year
Secondary Outcomes (11)
Rate of implant revisions
1 year
Rate of inappropriate therapy of the device
1 year
Atrial pacing percentage
1 year
Exercise test
1 year
Device detected AT
1 year
- +6 more secondary outcomes
Study Arms (2)
3-lead CRT implantation (CRT-D)
ACTIVE COMPARATORIn the 3-lead CRT implantation (CRT-D) group, conventional 3-lead CRT defibrillator system implantation will be performed. The CRT-D system is composed by three leads, one in atrium and two in both ventricles
2-lead CRT implantation (CRT-DX)
EXPERIMENTALIn the 2-lead CRT implantation (CRT-DX) group, 2-lead CRT defibrillator system implantation will be performed. The CRT-DX system is composed by two ventricular leads, the right one is provided with a dipole for atrial sensing
Interventions
Conventional 3-lead(1 atrial and 2 ventricular leads) system implantation
2-lead (2 ventricular leads with dipole for atrial sensing) DX system implantation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Any indication to atrial pacing according to current guidelines;
- 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;
- NYHA Class IV;
- Permanent Atrial Fibrillation
- Replacement of/upgrading from previously implanted pacing system;
- Dialysis patients;
- Pregnant or breast-feeding women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
ASST Rhodense
Rho, Milano, Italy
Ospedale di Camposampiero
Camposampiero, Padova, 35012, Italy
AOU Ospedali Riuniti Ancona
Ancona, Italy
Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi
Bologna, Italy
Fondazione Giovanni Paolo II
Campobasso, Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele - Presidio Ferrarotto
Catania, Italy
Clinica Sant'Anna
Catanzaro, 88100, Italy
Azienda Ospedaliera Pugliese Ciaccio
Catanzaro, Italy
Arcispedale Sant'Anna
Ferrara, 44124, Italy
Ospedale Santa Maria Nuova
Florence, 50122, Italy
Ospedale di Gorizia
Gorizia, 34170, Italy
Ospedale Vito Fazzi
Lecce, Italy
Ospedale Mater Salutis di Legnago
Legnago, Italy
Ospedale Carlo Poma
Mantova, Italy
IRCSS - Centro Neurolesi Bonino Pulejo
Messina, 98124, Italy
Ospedale San Gerardo
Monza, Italy
AOU Vanvitelli - Monaldi
Napoli, 88100, Italy
AO dei Colli - PO Monaldi
Napoli, Italy
Ospedale Federico II
Napoli, Italy
Azienda Ospedaliero - Universitaria di Parma
Parma, 43126, Italy
Fondazione Toscana Gabriele Monasterio
Pisa, Italy
Ospedale Giovanni Paolo II
Ragusa, 97100, Italy
Ospedale Molinette
Torino, 10126, Italy
Ospedali Riuniti Trieste
Trieste, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2018
First Posted
July 16, 2018
Study Start
October 22, 2018
Primary Completion
April 1, 2025
Study Completion
April 1, 2025
Last Updated
November 15, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share