Same Day Discharge
1 other identifier
interventional
40
1 country
1
Brief Summary
This study is to assess if subjects receiving a clinically indicated implanted cardiac pacemaker or defibrillator can be safely discharge home the same day of the procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2016
CompletedFirst Posted
Study publicly available on registry
October 24, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMay 3, 2017
May 1, 2017
2 years
October 21, 2016
May 1, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Average number of late complications between the 2 arms
up to 2 weeks after procedure
Study Arms (2)
Discharge day of Procedure
EXPERIMENTALSubjects in this arm will be discharged the same day of their cardiac device implant if deemed safe by treating physician.
Control
NO INTERVENTIONSubjects in this arm will remain in the hospital overnight per standard of care and will be discharged the next day if deemed safe by treating physician.
Interventions
Subjects will be discharged the day of the procedure if safe
Eligibility Criteria
You may qualify if:
- Scheduled for clinically indicated implant of cardiac pacemaker or defibrillator
- Willing and able to provide informed consent
- Appropriate clinical indication for the purpose of this study
- Primary prevention implantable cardioverter-defibrillator implant indicated for sudden cardiac death with ejection fraction more than 20%
- Sick sinus syndrome, non-high degree heart block as indication for pacemaker implant.
- No history of syncope
- No documented sudden cardiac death or ventricular arrhythmias requiring shock
- Adequate social support to be able to comply with protocol.
- Ability to complete remote monitor transmission
You may not qualify if:
- \. Determined to be at risk for bleeding or on oral anticoagulation 2. Planned to be implanted with non-Biotronik device 3. Complete heart block as indication for permanent pacemaker 4. Secondary ICD indication 5. Immediate procedural complication requiring prolonged admission such as: pneumothorax, large hematoma, tamponade) determined during the procedure or immediately before discharge.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandru Costea, MD
University of Cincinnati
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 21, 2016
First Posted
October 24, 2016
Study Start
November 1, 2016
Primary Completion
November 1, 2018
Study Completion
December 1, 2018
Last Updated
May 3, 2017
Record last verified: 2017-05