Same Day Discharge

Cardiac Arrhythmia Clinical Trial

Official title:

Same Day Discharge

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02943512
• Other study ID #: 2016-3696
• Status: Recruiting
• Phase: N/A
• First received: October 21, 2016
• Last updated: May 1, 2017
• Start date: November 2016
• Est. completion date: December 2018

Study information

• Verified date: May 2017
• Source: University of Cincinnati
• Contact: Alexandru Costea, MD
• Phone: 513-558-4272
• Email: costeaai[@]ucmail.uc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Intervention

Other:
• Discharge day of procedure
Subjects will be discharged the day of the procedure if safe

Locations

Country	Name	City	State
United States	University of Cincinnati Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average number of late complications between the 2 arms		up to 2 weeks after procedure