Phase
Condition
Heart Failure
Congestive Heart Failure
Chest Pain
Treatment
2-lead CRT defibrillator system implantation
Conventional 3-lead CRT defibrillator system implantation
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male and female patients ≥ 18 years old
- Patients willing to participate in the investigation and signing the Patient InformedConsent (PIC) Form;
- Indication to CRT-D implant according to current ESC Guidelines on cardiac pacing andcardiac 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 optimalmedical dosage; or, if rest HR<45 bpm: maximum heart rate at the 6- minute walkingtest >85 bpm.
Exclusion
Exclusion Criteria:
- Any indication to atrial pacing according to current guidelines;
- Both: resting heart rate <45 bpm at baseline ECG, with betablocker therapy at optimalmedical 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.
Study Design
Study Description
Connect with a study center
ASST Rhodense
Rho, Milano
ItalyActive - Recruiting
Ospedale di Camposampiero
Camposampiero, Padova 35012
ItalyActive - Recruiting
AOU Ospedali Riuniti Ancona
Ancona,
ItalyActive - Recruiting
AO Moscati
Avellino,
ItalySite Not Available
Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi
Bologna,
ItalyActive - Recruiting
Fondazione Giovanni Paolo II
Campobasso,
ItalyActive - Recruiting
AO S. Sebastiano
Caserta,
ItalySite Not Available
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele - Presidio Ferrarotto
Catania,
ItalyActive - Recruiting
Azienda Ospedaliera Pugliese Ciaccio
Catanzaro,
ItalyActive - Recruiting
Clinica Sant'Anna
Catanzaro, 88100
ItalyActive - Recruiting
Arcispedale Sant'Anna
Ferrara, 44124
ItalyActive - Recruiting
Ospedale Santa Maria Nuova
Firenze, 50122
ItalyActive - Recruiting
Ospedale di Gorizia
Gorizia, 34170
ItalySite Not Available
Ospedale Vito Fazzi
Lecce,
ItalyActive - Recruiting
Ospedale Mater Salutis di Legnago
Legnago,
ItalyActive - Recruiting
Ospedale Carlo Poma
Mantova,
ItalyActive - Recruiting
IRCSS - Centro Neurolesi Bonino Pulejo
Messina, 98124
ItalyActive - Recruiting
Ospedale San Gerardo
Monza,
ItalyActive - Recruiting
AO dei Colli - PO Monaldi
Napoli,
ItalyActive - Recruiting
AOU Vanvitelli - Monaldi
Napoli, 88100
ItalyActive - Recruiting
Ospedale Federico II
Napoli,
ItalyActive - Recruiting
Azienda Ospedaliero - Universitaria di Parma
Parma, 43126
ItalyActive - Recruiting
Fondazione Toscana Gabriele Monasterio
Pisa,
ItalyActive - Recruiting
Ospedale Giovanni Paolo II
Ragusa, 97100
ItalyActive - Recruiting
Policlinico Tor Vergata
Roma,
ItalySite Not Available
Ospedale Molinette
Torino, 10126
ItalyActive - Recruiting
Ospedali Riuniti Trieste
Trieste,
ItalyActive - Recruiting
Ospedale di Circolo e Fondazione Macchi, Cardiologia 1
Varese,
ItalySite Not Available
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