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Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure (CARRYING ON)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Italia
ClinicalTrials.gov Identifier:
NCT01216670
First received: April 21, 2010
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Heart Failure
Behavioral: remote patient's management
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure

Resource links provided by NLM:


Further study details as provided by Medtronic Italia:

Primary Outcome Measures:
  • Phase I: incidence of pre-specified clinical and arrhythmic events [ Time Frame: implant to 6 months post-implant ] [ Designated as safety issue: No ]

    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 II: incidence of pre-specified clinical and arrhythmic events [ Time Frame: implant to 24 months post-implant ] [ Designated as safety issue: No ]

    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:
  • Phase I: incidence of the pre-specified secondary clinical and arrhythmic events in patients implanted with the Reveal® XT [ Time Frame: implant to 6 months post-implant ] [ Designated as safety issue: No ]

    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 [ Time Frame: implant to 24 months post-implant ] [ Designated as safety issue: No ]

    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


Enrollment: 18
Study Start Date: February 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: remote patient's management
    scheduled remote CareLink data transmission
    Other Name: home monitoring
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Hf patients without indication to permanent device implant (PM/ICD/CRT)

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01216670

Locations
Italy
A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Alessandria, Italy, 15100
A.O. Ospedale S. Anna di Como
Como, Italy, 22100
Policlinico di Monza
Monza, Italy, 20052
Clinica San Gaudenzio
Novara, Italy, 28100
Sponsors and Collaborators
Medtronic Italia
Investigators
Study Chair: CARRYING ON Study Trial Leader Medtronic
  More Information

Publications:

Responsible Party: Medtronic Italia
ClinicalTrials.gov Identifier: NCT01216670     History of Changes
Other Study ID Numbers: MDT-CARRYINGONforHF
Study First Received: April 21, 2010
Last Updated: February 12, 2013
Health Authority: Italy: Ethics Committee
Italy: Ministry of Health

Keywords provided by Medtronic Italia:
Reveal® XT
Acute Heart Failure
Low Ejection Fraction
Reveal® XT implanted

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 20, 2014