Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure (CARRYINGON)

October 12, 2015 updated by: Medtronic Italia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy, 15100
        • A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria
      • Como, Italy, 22100
        • A.O. Ospedale S. Anna di Como
      • Monza, Italy, 20052
        • Policlinico di Monza
      • Novara, Italy, 28100
        • Clinica San Gaudenzio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase I: incidence of pre-specified clinical and arrhythmic events
Time Frame: 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
implant to 6 months post-implant
Phase II: incidence of pre-specified clinical and arrhythmic events
Time Frame: 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
implant to 24 months post-implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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.
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
Time Frame: 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
implant to 24 months post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Italia

Investigators

  • Study Chair: CARRYING ON Study Trial Leader, Medtronic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

April 21, 2010

First Submitted That Met QC Criteria

October 6, 2010

First Posted (Estimate)

October 7, 2010

Study Record Updates

Last Update Posted (Estimate)

October 14, 2015

Last Update Submitted That Met QC Criteria

October 12, 2015

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT-CARRYINGONforHF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on remote patient's management

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe