Same Day Discharge

University of Cincinnati40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Cardiac Arrhythmia

Interventions

Discharge day of procedureOTHER

Subjects will be discharged the day of the procedure if safe

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. \-

Locations (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

Average number of late complications between the 2 arms

Time frame: up to 2 weeks after procedure

Central Contacts

Alexandru Costea, MD

CONTACT

513-558-4272 costeaai@ucmail.uc.edu

Ginger Conway, MSN

CONTACT

513-558-3476 conwaygg@ucmail.uc.edu

Data from ClinicalTrials.gov

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