The CARRYING ON for heart failure (HF) study is a national, prospective, post market interventional, multi-center, open-label, pilot trial.The purpose of the study is to assess a short term and a long term period, incidence of pre-specified clinical and arrhythmic events in patients with a low ejection fraction (EF) that are hospitalized for acute cardiac decompensation.
The CARRYING ON for heart failure (HF) study is a national, prospective, post market interventional, multi-center, open-label, pilot trial designed in two phases. The purpose of the study is to assess a short term (6 months follow-up - Phase 1) and a long term period (24 months follow-up - Phase 2), incidence of pre-specified clinical and arrhythmic events in patients with a low ejection fraction (EF) that are hospitalized for acute cardiac decompensation. A previously implanted Reveal® XT device will be used to collect heart rhythm information.
Study Type
OBSERVATIONAL
Enrollment
18
scheduled remote CareLink data transmission
A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Alessandria, Alessandria, Italy
A.O. Ospedale S. Anna di Como
Como, Como, Italy
Policlinico di Monza
Monza, Monza, Italy
Clinica San Gaudenzio
Novara, Novara, Italy
Phase I: incidence of pre-specified clinical and arrhythmic events
In patients with low ejection fraction that are hospitalized for acute cardiac decompensation, the pre-specified events include: 1. Cardiovascular mortality or unplanned cardiovascular hospitalizations (including hospitalizations that will be scheduled due to pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy device implant) 2. Arrhythmic events
Time frame: implant to 6 months post-implant
Phase II: incidence of pre-specified clinical and arrhythmic events
In patients with low ejection fraction that are hospitalized for acute cardiac decompensation, the pre-specified events include: 1. Cardiovascular mortality or unplanned cardiovascular hospitalizations (including hospitalizations that will be scheduled due to pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy device implant) 2. Arrhythmic events
Time frame: implant to 24 months post-implant
Phase I: incidence of the pre-specified secondary clinical and arrhythmic events in patients implanted with the Reveal® XT
Document the incidence of the pre-specified secondary clinical and arrhythmic events in patients implanted with the Reveal XT. The pre-specified secondary clinical and arrhythmic events are: * Time to first detection of brady-tachyarrhythmia episode; * All cause mortality or unplanned cardiovascular hospitalization; * Unplanned cardiovascular hospitalization; * Heart Failure hospitalization; * Cardiovascular mortality; * Serious cardiovascular Adverse Events.
Time frame: implant to 6 months post-implant
Phase II: incidence of the pre-specified secondary clinical and arrhythmic events in patients implanted with the Reveal® XT
Document the incidence of the pre-specified secondary clinical and arrhythmic events in patients implanted with the Reveal XT. The pre-specified secondary clinical and arrhythmic events are: * Time to first detection of brady-tachyarrhythmia episode; * All cause mortality or unplanned cardiovascular hospitalization; * Unplanned cardiovascular hospitalization; * Heart Failure hospitalization; * Cardiovascular mortality; * Serious cardiovascular Adverse Events
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Time frame: implant to 24 months post-implant