Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure

Completed

• Conditions: Heart Failure

• Registration Number: NCT01216670
• Lead Sponsor: Medtronic Italia

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2010-04-21
• Study First Submitted QC: 2010-10-06
• Study First Posted: 2010-10-07
• Study Start: 2011-02
• Status Verified: 2013-02
• Primary Completion: 2013-11
• Study Completion: 2014-05
• Last Update Submitted: 2015-10-12
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Subject with a history of at least one heart failure (HF) hospitalization (as defined in the European Society of Cardiology or American College of Cardiology/American Heart Association guidelines), emergency department (ED) visit, or urgent office visit necessitating intravenous (IV) diuretic or augmentation of oral diuretic, IV inotropic, or IV vasodilator or other HF parenteral therapy within 15 days prior to device implant
• Subject has an implanted Reveal® XT device (less than 15 days post implant);
• Ejection Fraction (EF) less than 40 percent
• Patient with access to a telephone line
• Patient or the patient's caregiver is willing and able to use the Medtronic CareLink® Network Monitor and to perform the required duties at home or has a family member or assistant perform those duties
• Age greater than 18 years old
• Patient is willing and able to comply with the Clinical Investigation plan and willing to remain available for follow-up visit, through study closure
• Patient (or patient's legally authorized representative) is willing and able to sign and date the study Informed Consent

Exclusion Criteria

• New York Heart Association (NYHA) Class IV (chronic or ambulatory)
• Planned or previous implant of implantable cardioverter-defibrillator or pacemaker device
• Patient's life expectancy is less than one year due to non cardiovascular disorders, in the opinion of the physician
• Severe chronic obstructive pulmonary disorder (COPD)
• Chronic Atrial Fibrillation at time of enrollment
• ST segment elevation at time of electrocardiogram
• Cognitive disease
• Pregnancy or childbearing potential and not on reliable contraceptive
• Anticipated compliance problem or participation in another competitive trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase II: incidence of pre-specified clinical and arrhythmic events	implant to 24 months post-implant	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
Phase I: incidence of pre-specified clinical and arrhythmic events	implant to 6 months post-implant	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

Secondary Outcome Measures

Name	Time	Method
Phase II: incidence of the pre-specified secondary clinical and arrhythmic events in patients implanted with the Reveal® XT	implant to 24 months post-implant	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
Phase I: incidence of the pre-specified secondary clinical and arrhythmic events in patients implanted with the Reveal® XT	implant to 6 months post-implant	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.

Trial Locations

Locations (4)

A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria; 🇮🇹 Alessandria, Italy

A.O. Ospedale S. Anna di Como; 🇮🇹 Como, Italy

Policlinico di Monza; 🇮🇹 Monza, Italy

Clinica San Gaudenzio; 🇮🇹 Novara, Italy