Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact on Patient Outcome of Cardiac Implantable Electronic Device Complications (POINTED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03612635
Recruitment Status : Completed
First Posted : August 2, 2018
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Azienda Ospedaliera Cardinale G. Panico

Brief Summary:
The purpose of this registry is to evaluate the impact on patient outcome and on healthcare utilization of cardiac implantation electronic device complications during a long-term follow-up.

Condition or disease Intervention/treatment
Cardiac Implantable Electronic Device Complications Device: Implantation of a cardiac implantable electronic device

Detailed Description:
Multicentric, observational, prospective registry enrolling consecutive patients underwent pacemaker or defibrillator implantation, aimed to evaluate the impact of cardiac implantable device complications requiring surgical revision on healthcare utilization (number and length of hospitalizations), and on patient outcome (all-cause mortality and cardiac mortality), during a long-term follow-up.

Layout table for study information
Study Type : Observational
Actual Enrollment : 2811 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact on Patient Outcome and Healthcare Utilization of Cardiac ImplaNTable Electronic Devices Complications
Actual Study Start Date : January 1, 2010
Actual Primary Completion Date : December 31, 2012
Actual Study Completion Date : February 1, 2017

Intervention Details:
  • Device: Implantation of a cardiac implantable electronic device
    All patients enrolled in the registry underwent cardiac implantable electronic device implantation


Primary Outcome Measures :
  1. All-cause Death (dead/alive status assessment during follow-up) [ Time Frame: An average of 48 months ]
    Evaluation of all-cause mortality during follow-up


Secondary Outcome Measures :
  1. Occurrence of hospitalizations related to cardiac implantable electronic device complications [ Time Frame: An average of 48 months ]
    Evaluation of hospitalizations related to cardiac implantable electronic device complications



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with indication to receive a cardiac implantable electronic device (pacemaker or defibrillator).
Criteria

Inclusion Criteria:

  • patients underwent cardiac implantable electronic device implantation according to current guidelines during the enrollment period.

Exclusion Criteria:

  • patients already carriers of a cardiac implantable electronic device underwent replacement or upgrading of device.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03612635


Locations
Layout table for location information
Italy
"Card. G. Panico" Hospital
Tricase, Lecce, Italy, 73039
Federico Guerra
Ancona, Italy
Policlinico S.Orsola-Malpighi
Bologna, Italy, 40138
Mattia Laffi
Genova, Italy
Monaldi Hospital
Napoli, Italy
AOU "Maggiore della Carità"
Novara, Italy, 28100
Sponsors and Collaborators
Azienda Ospedaliera Cardinale G. Panico
Layout table for additonal information
Responsible Party: Azienda Ospedaliera Cardinale G. Panico
ClinicalTrials.gov Identifier: NCT03612635    
Other Study ID Numbers: POINTED
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No