CompletedNCT01216670CARRYINGONUpdated Oct 14, 2015

Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure

An observational study in Heart Failure, sponsored by Medtronic Italia. Completed at 4 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-14.

Sponsored by Medtronic Italia · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 18
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Heart Failure

Browse trials for

Heart Failure 5,701

Keywords

Reveal® XT
Acute Heart Failure
Low Ejection Fraction
Reveal® XT implanted

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 18 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Medtronic Italia is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

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

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

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

Observational model: Cohort
Time perspective: Prospective
Enrollment: 18 participants (actual)
Patient registry: No

Interventions

Behavioralremote patient's management
scheduled remote CareLink data transmission
Also known as: home monitoring

What researchers measure

Primary outcomes

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

Secondary outcomes

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
Time frame: implant to 24 months post-implant

Study locations

4 sites

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

References and documents

Publications

Fonarow GC; ADHERE Scientific Advisory Committee. The Acute Decompensated Heart Failure National Registry (ADHERE): opportunities to improve care of patients hospitalized with acute decompensated heart failure. Rev Cardiovasc Med. 2003;4 Suppl 7:S21-30. PubMed 14668697 ↗
Nieminen MS, Bohm M, Cowie MR, Drexler H, Filippatos GS, Jondeau G, Hasin Y, Lopez-Sendon J, Mebazaa A, Metra M, Rhodes A, Swedberg K, Priori SG, Garcia MA, Blanc JJ, Budaj A, Cowie MR, Dean V, Deckers J, Burgos EF, Lekakis J, Lindahl B, Mazzotta G, Morais J, Oto A, Smiseth OA, Garcia MA, Dickstein K, Albuquerque A, Conthe P, Crespo-Leiro M, Ferrari R, Follath F, Gavazzi A, Janssens U, Komajda M, Morais J, Moreno R, Singer M, Singh S, Tendera M, Thygesen K; ESC Committe for Practice Guideline (CPG). Executive summary of the guidelines on the diagnosis and treatment of acute heart failure: the Task Force on Acute Heart Failure of the European Society of Cardiology. Eur Heart J. 2005 Feb;26(4):384-416. doi: 10.1093/eurheartj/ehi044. Epub 2005 Jan 28. No abstract available. PubMed 15681577 ↗
Di Lenarda A, Scherillo M, Maggioni AP, Acquarone N, Ambrosio GB, Annicchiarico M, Bellis P, Bellotti P, De Maria R, Lavecchia R, Lucci D, Mathieu G, Opasich C, Porcu M, Tavazzi L, Cafiero M; TEMISTOCLE Investigators. Current presentation and management of heart failure in cardiology and internal medicine hospital units: a tale of two worlds--the TEMISTOCLE study. Am Heart J. 2003 Oct;146(4):E12. doi: 10.1016/S0002-8703(03)00315-6. PubMed 14564335 ↗
Tavazzi L, Maggioni AP, Lucci D, Cacciatore G, Ansalone G, Oliva F, Porcu M; Italian survey on Acute Heart Failure Investigators. Nationwide survey on acute heart failure in cardiology ward services in Italy. Eur Heart J. 2006 May;27(10):1207-15. doi: 10.1093/eurheartj/ehi845. Epub 2006 Apr 7. PubMed 16603579 ↗
O'Connor CM, Stough WG, Gallup DS, Hasselblad V, Gheorghiade M. Demographics, clinical characteristics, and outcomes of patients hospitalized for decompensated heart failure: observations from the IMPACT-HF registry. J Card Fail. 2005 Apr;11(3):200-5. doi: 10.1016/j.cardfail.2004.08.160. PubMed 15812748 ↗
Cleland JG, Swedberg K, Follath F, Komajda M, Cohen-Solal A, Aguilar JC, Dietz R, Gavazzi A, Hobbs R, Korewicki J, Madeira HC, Moiseyev VS, Preda I, van Gilst WH, Widimsky J, Freemantle N, Eastaugh J, Mason J; Study Group on Diagnosis of the Working Group on Heart Failure of the European Society of Cardiology. The EuroHeart Failure survey programme-- a survey on the quality of care among patients with heart failure in Europe. Part 1: patient characteristics and diagnosis. Eur Heart J. 2003 Mar;24(5):442-63. doi: 10.1016/s0195-668x(02)00823-0. PubMed 12633546 ↗
Fonarow GC, Stough WG, Abraham WT, Albert NM, Gheorghiade M, Greenberg BH, O'Connor CM, Sun JL, Yancy CW, Young JB; OPTIMIZE-HF Investigators and Hospitals. Characteristics, treatments, and outcomes of patients with preserved systolic function hospitalized for heart failure: a report from the OPTIMIZE-HF Registry. J Am Coll Cardiol. 2007 Aug 21;50(8):768-77. doi: 10.1016/j.jacc.2007.04.064. Epub 2007 Aug 6. PubMed 17707182 ↗
Braunschweig F. Therapeutic and diagnostic role of electrical devices in acute heart failure. Heart Fail Rev. 2007 Jun;12(2):157-66. doi: 10.1007/s10741-007-9019-0. PubMed 17447136 ↗
Vanoli E, Mortara A, Diotallevi P, Gallone G, Mariconti B, Gronda E, Gentili A, Bisetti S, Botto GL. Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure: Results from the CARRYING ON for HF Pilot Study. JMIR Res Protoc. 2016 Apr 26;5(2):e62. doi: 10.2196/resprot.4380. PubMed 27118481 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01216670
Lead sponsor: Medtronic Italia
Responsible party: Sponsor
First posted: Oct 7, 2010
Start date: Feb 2011
Primary completion: Nov 2013
Completion: May 2014
Last update: Oct 14, 2015

Study contacts

CARRYING ON Study Trial Leader

study chair · Medtronic

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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