Back to results

Same Day Discharge

Primary Purpose

Cardiac Arrhythmia

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Discharge day of procedure

About this trial

This is an interventional health services research trial for Cardiac Arrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
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
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.

Sites / Locations

University of Cincinnati Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Discharge day of Procedure

Control

Arm Description

Subjects in this arm will be discharged the same day of their cardiac device implant if deemed safe by treating physician.

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.

Outcomes

Primary Outcome Measures

Average number of late complications between the 2 arms

Secondary Outcome Measures

Full Information

NCT ID

NCT02943512

First Posted

October 21, 2016

Last Updated

May 1, 2017

Sponsor

University of Cincinnati

1. Study Identification

Unique Protocol Identification Number

NCT02943512

Brief Title

Same Day Discharge

Official Title

Same Day Discharge

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Unknown status

Study Start Date

November 2016 (undefined)

Primary Completion Date

November 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Cincinnati

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiac Arrhythmia

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Discharge day of Procedure

Arm Type

Experimental

Arm Description

Subjects in this arm will be discharged the same day of their cardiac device implant if deemed safe by treating physician.

Arm Title

Control

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Discharge day of procedure

Intervention Description

Subjects will be discharged the day of the procedure if safe

Primary Outcome Measure Information:

Title

Average number of late complications between the 2 arms

Time Frame

up to 2 weeks after procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alexandru Costea, MD

Phone

513-558-4272

costeaai@ucmail.uc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Ginger Conway, MSN

Phone

513-558-3476

conwaygg@ucmail.uc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexandru Costea, MD

Organizational Affiliation

University of Cincinnati

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Cincinnati Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexandru Costea, MD

Phone

513-558-4272

costeaai@ucmail.uc.edu

First Name & Middle Initial & Last Name & Degree

Ginger Conway, MSN

Phone

513-558-3476

conwaygg@ucmail.uc.edu

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Same Day Discharge

We'll reach out to this number within 24 hrs