Same Day Subcutaneous ICD And Send Home (DASH)

NCT03504839 | Completed Results DMC FDA Device

• 1 other identifier: 2017H00451
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Design: Prospective, non-randomized single center study at The Ohio State University Wexner Medical Center. Purpose: The purpose of this study is to prospectively evaluate a specific analgesia protocol designed to allow for same day discharge following implantation of the subcutaneous implantable cardiac defibrillator (S-ICD) Enrollment: Up to 40 subjects will be enrolled. Subject Population: Consecutive patients undergoing S-ICD implantation under general anesthesia or monitored anesthesia care. Endpoints: Rate of successful completion of the protocol; Procedural complications; Serial assessment of patient perception of pain.

Conditions

Cardiomyopathies; Cardiac Death, Sudden

Keywords

defibrillator

Outcome Measures

Primary Outcomes (1)

• Rate of Successful Completion of S-ICD Implantation and Discharge of the Patient on the Same Day the Device is Implanted Using the Analgesia Protocol.

  Rate of successful completion of S-ICD implantation and discharge of the patient on the same day the device is implanted using the analgesia protocol.

  within 30 days of the procedure

Secondary Outcomes (6)

• Procedure Complication (Failed Implantation, Infection, Hematoma/Bleeding, Etc…) Within 30 Days of Procedure.

  within 30 days of the procedure

• Serial Assessment of Patient Perception of Pain Using the Graded Integer Pain Scale of 0-10

  within 30 days of the procedure

• Side Effects Related to Medical Therapy of Protocol.

  within 30 days of the procedure

• Time From Beginning of Recovery (Defined as When the Patient Enters the Recovery IPR Room) to the Time of Discharge From the Recovery Unit.

  within 30 days of the procedure

• 30 Day Readmission Rate After Discharge Following S-ICD Implant

  within 30 days of the procedure

Study Arms (1)

Intervention

OTHER

S-ICD implantation.

Device: Subcutaneous ICD with same day discharge

Interventions

Subcutaneous ICD with same day discharge DEVICE

Receiving a SICD and discharged the same day

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient consented for implantation of S-ICD.
• Ambulatory/outpatient patient coming to the hospital setting solely for implantation of S-ICD
• Patient agrees to participate and is able to comply with the defined study protocol, including assistance for home care and transportation for the first ≈12-18 hours post discharge, and compliance with the required follow up.

You may not qualify if:

• Inability or unwillingness to provide informed consent
• Patients who, for any reason, was hospitalized or in an emergency department the day prior to the S-ICD implantation, including patients transferred for S-ICD implantation
• Patients in which the hemodynamics are dependent upon intravenous pressors infusing at the time of device implantation or mechanical support, inclusive of left ventricular assist device and intravenous devices (balloon pump, Impella device).
• Age \< 18 years.
• Pregnancy.
• Currently incarcerated.
• Hypoxia (room air oxygen \<91%) or acutely short of breath.
• Hypotension (Systolic blood pressure \<90) unless this is patient's typical blood pressure).
• Bradycardia (heart rate \<45bpm, unless this is patient's typical resting heart rate).
• Acute electrolyte disorder that cannot be easily corrected (e.g., potassium supplementations) based upon Chem 6 values obtained on day of procedure.
• Presence of a fever.

Sponsors & Collaborators

• Emile Daoud, MD: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Cardiomyopathies; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Arrest; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Research Coordinator - Adrianne Miller
• Organization: The Ohio State University Medical Center

adrianne.miller3@osumc.edu

614-688-8252

Study Officials

• Toshimasa Okabe, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sub-Investigator

Model Details: Consecutive patients consented for SICD as per standard indications for device implantation

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 20, 2018
• Study Start: January 15, 2018
• Primary Completion: April 12, 2019
• Study Completion: April 12, 2019
• Last Updated: September 23, 2021
• Results First Posted: September 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)