Same Day Discharge
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Arrhythmia
- Sponsor
- University of Cincinnati
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Average number of late complications between the 2 arms
- Last Updated
- 9 years ago
Overview
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.
Detailed Description
Subjects who are implanted with a clinically indicated implanted cardiac pacemaker or defibrillator will be randomized to standard of care (next day discharge) versus same day discharge post implant. Both groups will under go standard of care assessments prior to discharge. The same day discharge group will receive a phone call the next day to assess for events and will transmit device data electronically. Both groups will be seen 10 - 14 days after implant for further evaluation. The subjects will also complete questionnaires regarding their knowledge of self care and satisfaction with care.
Investigators
Alexandru Costea
Principal Investigator
University of Cincinnati
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Determined to be at risk for bleeding or on oral anticoagulation
- •Planned to be implanted with non-Biotronik device
- •Complete heart block as indication for permanent pacemaker
- •Secondary ICD indication
- •Immediate procedural complication requiring prolonged admission such as: pneumothorax, large hematoma, tamponade) determined during the procedure or immediately before discharge.
Outcomes
Primary Outcomes
Average number of late complications between the 2 arms
Time Frame: up to 2 weeks after procedure