Impact on Patient Outcome of Cardiac Implantable Electronic Device Complications
POINTED
Impact on Patient Outcome and Healthcare Utilization of Cardiac ImplaNTable Electronic Devices Complications
1 other identifier
observational
2,811
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2010
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 19, 2018
CompletedFirst Posted
Study publicly available on registry
August 2, 2018
CompletedAugust 2, 2018
July 1, 2018
3 years
July 19, 2018
July 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
All-cause Death (dead/alive status assessment during follow-up)
Evaluation of all-cause mortality during follow-up
An average of 48 months
Secondary Outcomes (1)
Occurrence of hospitalizations related to cardiac implantable electronic device complications
An average of 48 months
Interventions
All patients enrolled in the registry underwent cardiac implantable electronic device implantation
Eligibility Criteria
Patients with indication to receive a cardiac implantable electronic device (pacemaker or defibrillator).
You may qualify if:
- patients underwent cardiac implantable electronic device implantation according to current guidelines during the enrollment period.
You may not qualify if:
- patients already carriers of a cardiac implantable electronic device underwent replacement or upgrading of device.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
"Card. G. Panico" Hospital
Tricase, Lecce, 73039, Italy
Federico Guerra
Ancona, Italy
Policlinico S.Orsola-Malpighi
Bologna, 40138, Italy
Mattia Laffi
Genova, Italy
Monaldi Hospital
Napoli, Italy
AOU "Maggiore della Carità"
Novara, 28100, Italy
Related Publications (1)
Palmisano P, Sergi C, Panico V, Chiarillo MV, Chiuri MD, Martella ML, Stefanelli G, Martella D, Mauro R, Ponzetta MA, Parlavecchio A, Accogli M, Coluccia G. Impact on nurse workload and patient satisfaction of atrioventricular junction ablation performed simultaneously with conduction system pacing using a superior approach from the pocket compared with the conventional femoral approach. Eur J Cardiovasc Nurs. 2024 Oct 21;23(7):746-755. doi: 10.1093/eurjcn/zvae043.
PMID: 38552177DERIVED
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2018
First Posted
August 2, 2018
Study Start
January 1, 2010
Primary Completion
December 31, 2012
Study Completion
February 1, 2017
Last Updated
August 2, 2018
Record last verified: 2018-07