Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
640 participants
INTERVENTIONAL
2018-10-22
2025-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
Conventional 3-lead CRT defibrillator system implantation
Conventional 3-lead(1 atrial and 2 ventricular leads) system implantation
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
2-lead CRT defibrillator system implantation
2-lead (2 ventricular leads with dipole for atrial sensing) DX system implantation
Interventions
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Conventional 3-lead CRT defibrillator system implantation
Conventional 3-lead(1 atrial and 2 ventricular leads) system implantation
2-lead CRT defibrillator system implantation
2-lead (2 ventricular leads with dipole for atrial sensing) DX system implantation
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Associazione Portatori Dispositivi Impiantabili Cardiaci
OTHER
Responsible Party
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Locations
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ASST Rhodense
Rho, Milano, Italy
Ospedale di Camposampiero
Camposampiero, Padova, 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, , Italy
Azienda Ospedaliera Pugliese Ciaccio
Catanzaro, , Italy
Arcispedale Sant'Anna
Ferrara, , Italy
Ospedale Santa Maria Nuova
Florence, , Italy
Ospedale di Gorizia
Gorizia, , Italy
Ospedale Vito Fazzi
Lecce, , Italy
Ospedale Mater Salutis di Legnago
Legnago, , Italy
Ospedale Carlo Poma
Mantova, , Italy
IRCSS - Centro Neurolesi Bonino Pulejo
Messina, , Italy
Ospedale San Gerardo
Monza, , Italy
AOU Vanvitelli - Monaldi
Napoli, , Italy
AO dei Colli - PO Monaldi
Napoli, , Italy
Ospedale Federico II
Napoli, , Italy
Azienda Ospedaliero - Universitaria di Parma
Parma, , Italy
Fondazione Toscana Gabriele Monasterio
Pisa, , Italy
Ospedale Giovanni Paolo II
Ragusa, , Italy
Ospedale Molinette
Torino, , Italy
Ospedali Riuniti Trieste
Trieste, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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APDIC
Identifier Type: -
Identifier Source: org_study_id
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