Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure

NCT01216670 | Completed

• 1 other identifier: MDT-CARRYINGONforHF
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 4

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.

Conditions

Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  implant to 24 months post-implant

Secondary Outcomes (2)

• 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

• 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

Interventions

remote patient's management BEHAVIORAL

scheduled remote CareLink data transmission

Also known as: home monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Italia: lead

Study Sites (4)

A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Alessandria, Alessandria, 15100, Italy

Location

A.O. Ospedale S. Anna di Como

Como, Como, 22100, Italy

Location

Policlinico di Monza

Monza, Monza, 20052, Italy

Location

Clinica San Gaudenzio

Novara, Novara, 28100, Italy

Location

Related Publications (9)

• 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.

  PMID: 14668697 BACKGROUND

• 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.

  PMID: 15681577 BACKGROUND

• 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.

  PMID: 14564335 BACKGROUND

• 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.

  PMID: 16603579 BACKGROUND

• 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.

  PMID: 15812748 BACKGROUND

• 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.

  PMID: 12633546 BACKGROUND

• 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.

  PMID: 17707182 BACKGROUND

• 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.

  PMID: 17447136 BACKGROUND

• 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.

  PMID: 27118481 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Study Officials

• CARRYING ON Study Trial Leader

  Medtronic

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2010
• First Posted: October 7, 2010
• Study Start: February 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: May 1, 2014
• Last Updated: October 14, 2015

Record last verified: 2013-02

Locations

IT (4)