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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
640
Conventional 3-lead(1 atrial and 2 ventricular leads) system implantation
2-lead (2 ventricular leads with dipole for atrial sensing) DX system implantation
ASST Rhodense
Rho, Milano, Italy
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)
Time frame: 1 year
Rate of implant revisions
Rate of implant revisions to add, replace, reposition, and remove an atrial pacing lead.
Time frame: 1 year
Rate of inappropriate therapy of the device
Inappropriate detections and interventions of high rate ventricular episodes.
Time frame: 1 year
Atrial pacing percentage
In the conventional CRT-D group, atrial pacing percentage.
Time frame: 1 year
Exercise test
Six minute walking test distance at one year
Time frame: 1 year
Device detected AT
Incidence of atrial tachyarrhythmias (AT)
Time frame: 1 year
Incidence of appropriate Ventricular therapy
Incidence of Ventricular Arrhythmias (VA) requiring therapy delivery
Time frame: 1 year
Incidence of events due to short-long-short sequence
Incidence of both VA and AT due to bradycardia or short-long-short sequence
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Ospedale di Camposampiero
Camposampiero, Padova, Italy
RECRUITINGAOU Ospedali Riuniti Ancona
Ancona, Italy
RECRUITINGAzienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi
Bologna, Italy
RECRUITINGFondazione Giovanni Paolo II
Campobasso, Italy
RECRUITINGAzienda Ospedaliero Universitaria Policlinico Vittorio Emanuele - Presidio Ferrarotto
Catania, Italy
RECRUITINGClinica Sant'Anna
Catanzaro, Italy
RECRUITINGAzienda Ospedaliera Pugliese Ciaccio
Catanzaro, Italy
RECRUITINGArcispedale Sant'Anna
Ferrara, Italy
RECRUITINGOspedale Santa Maria Nuova
Florence, Italy
RECRUITING...and 14 more locations
Time frame: 1 year
Implant failure
Impossibility to implant any component (leads and device) of the initially planned system
Time frame: 1 year
Procedure times
Skin-to-skin and fluoroscopy time
Time frame: 1 year
Atrial sensing amplitude measured by device
Atrial sensing amplitude measured by devices in both investigation arms
Time frame: 1 year
Far field oversensing incidence
Incidence of far field oversensing episodes in both investigation arms
Time frame: 1 year