NCT03587064

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
640

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 16, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

October 22, 2018

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2025

Completed
Last Updated

July 6, 2026

Status Verified

July 1, 2026

Enrollment Period

6.5 years

First QC Date

June 14, 2018

Last Update Submit

July 2, 2026

Conditions

Heart FailureCardiac Resynchronization Therapy

Keywords

CRT-DCRT-DXAtrial pacing

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 COMPARATOR

In 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

Device: Conventional 3-lead CRT defibrillator system implantation

2-lead CRT implantation (CRT-DX)

EXPERIMENTAL

In 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

Device: 2-lead CRT defibrillator system implantation

Interventions

Conventional 3-lead CRT defibrillator system implantationDEVICE

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

3-lead CRT implantation (CRT-D)
2-lead CRT defibrillator system implantationDEVICE

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

2-lead CRT implantation (CRT-DX)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

AOU Ospedali Riuniti Ancona

Ancona, Ancona, Italy

Location

Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi

Bologna, Bologna, Italy

Location

Fondazione Giovanni Paolo II

Campobasso, Campobasso, Italy

Location

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele - Presidio Ferrarotto

Catania, Catania, Italy

Location

Clinica Sant'Anna

Catanzaro, Catanzaro, 88100, Italy

Location

Azienda Ospedaliera Pugliese Ciaccio

Catanzaro, Catanzaro, Italy

Location

Arcispedale Sant'Anna

Ferrara, Ferrara, 44124, Italy

Location

Ospedale Santa Maria Nuova

Florence, Firenze, 50122, Italy

Location

Ospedale di Gorizia

Gorizia, Gorizia, 34170, Italy

Location

Ospedale Vito Fazzi

Lecce, Lecce, Italy

Location

Ospedale Carlo Poma

Mantua, Mantova, Italy

Location

IRCSS - Centro Neurolesi Bonino Pulejo

Messina, Messina, 98124, Italy

Location

ASST Rhodense

Rho, Milano, Italy

Location

Ospedale San Gerardo

Monza, Monza, Italy

Location

AOU Vanvitelli - Monaldi

Naples, Napoli, 88100, Italy

Location

AO dei Colli - PO Monaldi

Naples, Napoli, Italy

Location

Ospedale Federico II

Naples, Napoli, Italy

Location

Ospedale di Camposampiero

Camposampiero, Padova, 35012, Italy

Location

Azienda Ospedaliero - Universitaria di Parma

Parma, Parma, 43126, Italy

Location

Fondazione Toscana Gabriele Monasterio

Pisa, Pisa, Italy

Location

Ospedale Giovanni Paolo II

Ragusa, Ragusa, 97100, Italy

Location

Ospedale Molinette

Torino, Torino, 10126, Italy

Location

Ospedali Riuniti Trieste

Trieste, Trieste, Italy

Location

Ospedale Mater Salutis di Legnago

Legnago, Italy

Location

Related Publications (1)

  • Biffi M, Rovaris G, Pisano ECL, Calvi V, Rapacciuolo A, Santamaria M, Maglia G, Zanotto G, Bertaglia E, Nigro G, Giomi A, Notarangelo F, Pepi P, D'Alterio G, Castagno D, Dello Russo A, Nicosia A, Zecchin M, Bertini M, Duca A, Giacopelli D, Gargaro A, Botto GL; CRT-NEXT Study Group. Role of Atrial Pacing Support in Cardiac Resynchronization Therapy: A Noninferiority Randomized Trial. Circulation. 2026 Jun 2;153(22):1707-1718. doi: 10.1161/CIRCULATIONAHA.126.079859. Epub 2026 Mar 30.

    PMID: 41910411DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

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 30, 2025

Study Completion

May 7, 2025

Last Updated

July 6, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(24)