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Same Day Discharge

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ClinicalTrials.gov Identifier: NCT02943512
Recruitment Status : Recruiting
First Posted : October 24, 2016
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Alexandru Costea, University of Cincinnati

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.

Condition or disease Intervention/treatment Phase
Cardiac Arrhythmia Other: Discharge day of procedure Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Same Day Discharge
Study Start Date : November 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Discharge day of Procedure
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
Subjects will be discharged the day of the procedure if safe

No Intervention: Control
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.



Primary Outcome Measures :
  1. Average number of late complications between the 2 arms [ Time Frame: up to 2 weeks after procedure ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02943512


Contacts
Contact: Alexandru Costea, MD 513-558-4272 costeaai@ucmail.uc.edu
Contact: Ginger Conway, MSN 513-558-3476 conwaygg@ucmail.uc.edu

Locations
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Alexandru Costea, MD    513-558-4272    costeaai@ucmail.uc.edu   
Contact: Ginger Conway, MSN    513-558-3476    conwaygg@ucmail.uc.edu   
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Alexandru Costea, MD University of Cincinnati

Responsible Party: Alexandru Costea, Principal Investigator, University of Cincinnati
ClinicalTrials.gov Identifier: NCT02943512     History of Changes
Other Study ID Numbers: 2016-3696
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes