Same Day Discharge

Study 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.

Official Title
-----------------
Same Day Discharge

Conditions
-----------------
Cardiac Arrhythmia

Intervention / Treatment
-----------------
* Other: Discharge day of procedure


Participation Criteria
=================
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: 1. 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. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Discharge day of Procedure<br>Subjects in this arm will be discharged the same day of their cardiac device implant if deemed safe by treating physician. | Other: Discharge day of procedure<br>* Subjects will be discharged the day of the procedure if safe<br>|
| No Intervention: Control<br>Subjects 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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average number of late complications between the 2 arms |  | up to 2 weeks after procedure |