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Comparison of CRT-D and CRT-DX Systems (CRT-NEXT)

NCT03587064 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 640

Last updated 2023-11-15

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Conventional 3-lead CRT defibrillator system implantation

Conventional 3-lead(1 atrial and 2 ventricular leads) system implantation

DEVICE

2-lead CRT defibrillator system implantation

2-lead (2 ventricular leads with dipole for atrial sensing) DX system implantation

Sponsors & Collaborators

  • Associazione Portatori Dispositivi Impiantabili Cardiaci

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-22
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03587064 on ClinicalTrials.gov