CARRYINGON: Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure

Sponsor

Medtronic Italia (Industry)

Overall Status

Completed

CT.gov ID

NCT01216670

Collaborator

(none)

Enrollment

Locations

38.9

Duration (Months)

4.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Behavioral: remote patient's management

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 Design

Study Type:

Observational

Actual Enrollment :

18 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

May 1, 2014

Outcome Measures

Primary Outcome Measures

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: Cardiovascular mortality or unplanned cardiovascular hospitalizations (including hospitalizations that will be scheduled due to pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy device implant) Arrhythmic events
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: Cardiovascular mortality or unplanned cardiovascular hospitalizations (including hospitalizations that will be scheduled due to pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy device implant) Arrhythmic events

Secondary Outcome Measures

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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria	Alessandria	Italy	15100
2	A.O. Ospedale S. Anna di Como	Como	Italy	22100
3	Policlinico di Monza	Monza	Italy	20052
4	Clinica San Gaudenzio	Novara	Italy	28100