Actions Elicited by In-hospital Follow-up of Cardiac Devices

NCT01073449 | Completed Results

• 1 other identifier: GAVBS1
• Study Type: observational
• Target: 3,362
• Locations: 1 country
• Sites: 8

Brief Summary

This study will enroll all patients who will attend an in-hospital follow-up of cardiac device since February 22nd 2010 to June 21st 2010. Primary objective of the study is to observe how many of patients seen during these period (approximately 5000) will receive a change in cardiac device programming or in drug therapy or a scheduled or urgent hospital admission. These data should help to clarify how useful and safe is a remote monitoring strategy for this kind of patients.

Conditions

Cardiac Pacemaker, Artificial; Implantable Cardioverter-Defibrillator

Keywords

Cardiac devices; In-Hospital Follow-up; Analytical

Outcome Measures

Primary Outcomes (1)

• Number of Patients of the Whole Population in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up

  4 months

Secondary Outcomes (2)

• Number of Patients -Amongst Those Implanted With a Pacemaker - in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up

  4 months

• Number of Patients - Amongst Those Implanted With an Implantable Cardioverter Defibrillator (ICD)- in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up

  4 months

Study Arms (1)

Cardiac device

All patients implanted with a cardiac device, pacemaker(PM)or Implantable Cardioverter Defibrillator (ICD)

Procedure: In-hospital follow-up of cardiac device

Interventions

In-hospital follow-up of cardiac device PROCEDURE

Electrical measures taken during normal follow-up and clinical status of the patient

Cardiac device

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who will undergo an in-hospital follow-up of a cardiac device

You may qualify if:

• All patients with a cardiac device

You may not qualify if:

• Follow-up of a cardiac device at discharge from hospital after first implant

Sponsors & Collaborators

• Cliniche Humanitas Gavazzeni: lead

Study Sites (8)

U.O. Aritmologia - Cliniche Humanitas Gavazzeni

Bergamo, Bergamo, 24121, Italy

Location

Laboratorio di Elettrofisiologia - Spedali Civili

Brescia, Brescia, 25123, Italy

Location

Laboratorio di Elettrofisiologia

Desenzano del Garda, Brescia, 25015, Italy

Location

Laboratorio di Cardiologia - Ospedale Civile

Casalmaggiore, Cremona, 26041, Italy

Location

Laboratorio di Elettrofisiologia - Ospedale A. Manzoni

Lecco, Lecco, 23900, Italy

Location

Laboratorio di Elettrofisiologia

Merate, Lecco, 23807, Italy

Location

Laboratorio di Elettrofisiologia - Ospedale Carlo Poma

Mantova, Mantova, 46100, Italy

Location

Laboratorio di Elettrofisiologia - Ospedale San Matteo

Pavia, Pavia, 27100, Italy

Location

Related Publications (4)

• Senges-Becker JC, Klostermann M, Becker R, Bauer A, Siegler KE, Katus HA, Schoels W. What is the "optimal" follow-up schedule for ICD patients? Europace. 2005 Jul;7(4):319-26. doi: 10.1016/j.eupc.2005.02.117.

  PMID: 15944090 BACKGROUND

• Fauchier L, Sadoul N, Kouakam C, Briand F, Chauvin M, Babuty D, Clementy J. Potential cost savings by telemedicine-assisted long-term care of implantable cardioverter defibrillator recipients. Pacing Clin Electrophysiol. 2005 Jan;28 Suppl 1:S255-9. doi: 10.1111/j.1540-8159.2005.00071.x.

  PMID: 15683509 BACKGROUND

• Brugada P. What evidence do we have to replace in-hospital implantable cardioverter defibrillator follow-up? Clin Res Cardiol. 2006;95 Suppl 3:III3-9. doi: 10.1007/s00392-006-1302-x.

  PMID: 16598602 RESULT

• Mascioli G, Curnis A, Landolina M, Klersy C, Gelmini GP, Ruffa F; ATHENS Investigators. Actions elicited during scheduled and unscheduled in-hospital follow-up of cardiac devices: results of the ATHENS multicentre registry. Europace. 2011 Dec;13(12):1766-73. doi: 10.1093/europace/eur233. Epub 2011 Jul 14.

  PMID: 21764815 DERIVED

Results Point of Contact

• Title: Dr. Giosue Mascioli
• Organization: Dept. of Arrhythmology - Cliniche Humanitas Gavazzeni

giosuemascioli@mac.com

+39 035 4204159

Study Officials

• Giosue Mascioli, MD

  Cliniche Humanitas Gavazzeni

  STUDY CHAIR

• Antonio Curnis, MD

  Spedali Civili di Brescia

  STUDY CHAIR

• Maurizio Landolina, MD

  Policlinico San Matteo Pavia

  PRINCIPAL INVESTIGATOR

• Gian-Paolo Gelmini, MD

  Ospedale Civile di Desenzano d/Garda

  PRINCIPAL INVESTIGATOR

• Franco Ruffa, MD

  Ospedale A. Manzoni - Lecco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: February 23, 2010
• Study Start: February 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: February 28, 2011
• Results First Posted: February 28, 2011

Record last verified: 2011-01

Locations

IT (8)