Same Day Discharge

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02943512

Enrollment

Registered

2016-10-24

Start date

2016-11-30

Completion date

2018-12-31

Last updated

2017-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrhythmia

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.

Interventions

OTHERDischarge day of procedure

Subjects will be discharged the day of the procedure if safe

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Scheduled for clinically indicated implant of cardiac pacemaker or defibrillator 2. Willing and able to provide informed consent 3. Appropriate clinical indication for the purpose of this study 1. Primary prevention implantable cardioverter-defibrillator implant indicated for sudden cardiac death with ejection fraction more than 20% 2. Sick sinus syndrome, non-high degree heart block as indication for pacemaker implant. 3. No history of syncope 4. No documented sudden cardiac death or ventricular arrhythmias requiring shock 4. Adequate social support to be able to comply with protocol. 5. 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. \-

Design outcomes

Primary

Measure	Time frame
Average number of late complications between the 2 arms	up to 2 weeks after procedure

Countries

United States

Contacts

Primary ContactAlexandru Costea, MD

costeaai@ucmail.uc.edu513-558-4272

Backup ContactGinger Conway, MSN

conwaygg@ucmail.uc.edu513-558-3476

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026