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

November 14, 2023 updated by: Associazione Portatori Dispositivi Impiantabili Cardiaci

Non-inferiority Randomized Clinical Investigation of CRT-DX Versus CRT-D Systems

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Resting heart rate is strongly associated with incident worsening Heart Failure (HF) and mortality. Current devices for cardiac resynchronization (CRT-D) normally provide atrio-ventricular (AV) sequential pacing modes during resynchronization, but the best pacing programming strategy is not clear.

On the one hand a basic rate of 50 to 70 bpm (optionally with some rate-responsive function) could be considered for therapy up-titration, specifically betablockers; on the other hand, increasing pacing rates may partially reduce benefits from resynchronization, reducing filling time and contractility reservoir.

The Pegasus investigation is the only large randomized investigation comparing DDD with 70 bpm basic rate to DDD(R) @40 bpm. Results showed no difference in investigation endpoints, including mortality and HF-hospitalization.

These results may support the use of a device implementing both a CRT function and a right ventricular single-lead with and an atrial sensing dipole (CRT-DX system). This system can track ventricular pacing and resynchronization following atrial sensing, even if it cannot provide atrial pacing support. It should be assessed whether such limitation is counterbalanced by the advantages related to the reduced number of necessary leads, with simplified implantation and less complications.

The objective of the investigation is to assess whether atrial pacing support is really necessary in the subset of patients with indication to CRT-D and no evidence of sinus dysfunction on optimal therapy. The investigation will test the hypothesis that a CRT-DX system is not inferior to a conventional CRT-D system in this class of subjects.

Study Type

Interventional

Enrollment (Estimated)

640

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Ancona, Italy
      • Bologna, Italy
        • Recruiting
        • Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi
        • Contact:
      • Campobasso, Italy
      • Catania, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele - Presidio Ferrarotto
        • Contact:
      • Catanzaro, Italy
        • Recruiting
        • Azienda Ospedaliera Pugliese Ciaccio
        • Contact:
      • Catanzaro, Italy, 88100
      • Ferrara, Italy, 44124
      • Firenze, Italy, 50122
      • Gorizia, Italy, 34170
        • Active, not recruiting
        • Ospedale di Gorizia
      • Lecce, Italy
      • Legnago, Italy
        • Recruiting
        • Ospedale Mater Salutis di Legnago
        • Contact:
      • Mantova, Italy
      • Messina, Italy, 98124
      • Monza, Italy
        • Recruiting
        • Ospedale San Gerardo
        • Contact:
      • Napoli, Italy, 88100
      • Napoli, Italy
      • Napoli, Italy
      • Parma, Italy, 43126
        • Recruiting
        • Azienda Ospedaliero - Universitaria Di Parma
        • Contact:
      • Pisa, Italy
      • Ragusa, Italy, 97100
      • Torino, Italy, 10126
      • Trieste, Italy
    • Milano
      • Rho, Milano, Italy
    • Padova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 3-lead CRT implantation (CRT-D)
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
Conventional 3-lead(1 atrial and 2 ventricular leads) system implantation
Experimental: 2-lead CRT implantation (CRT-DX)
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
2-lead (2 ventricular leads with dipole for atrial sensing) DX system implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combined endpoint of Mortality, hospitalization due to cardiac causes and lead-related complications
Time Frame: 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of implant revisions
Time Frame: 1 year
Rate of implant revisions to add, replace, reposition, and remove an atrial pacing lead.
1 year
Rate of inappropriate therapy of the device
Time Frame: 1 year
Inappropriate detections and interventions of high rate ventricular episodes.
1 year
Atrial pacing percentage
Time Frame: 1 year
In the conventional CRT-D group, atrial pacing percentage.
1 year
Exercise test
Time Frame: 1 year
Six minute walking test distance at one year
1 year
Device detected AT
Time Frame: 1 year
Incidence of atrial tachyarrhythmias (AT)
1 year
Incidence of appropriate Ventricular therapy
Time Frame: 1 year
Incidence of Ventricular Arrhythmias (VA) requiring therapy delivery
1 year
Incidence of events due to short-long-short sequence
Time Frame: 1 year
Incidence of both VA and AT due to bradycardia or short-long-short sequence
1 year
Implant failure
Time Frame: 1 year
Impossibility to implant any component (leads and device) of the initially planned system
1 year
Procedure times
Time Frame: 1 year
Skin-to-skin and fluoroscopy time
1 year
Atrial sensing amplitude measured by device
Time Frame: 1 year
Atrial sensing amplitude measured by devices in both investigation arms
1 year
Far field oversensing incidence
Time Frame: 1 year
Incidence of far field oversensing episodes in both investigation arms
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Associazione Portatori Dispositivi Impiantabili Cardiaci

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2018

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

June 14, 2018

First Submitted That Met QC Criteria

July 13, 2018

First Posted (Actual)

July 16, 2018

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APDIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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