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Same Day Subcutaneous ICD And Send Home (DASH)

NCT03504839 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2021-09-23

Study results available
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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

Interventions

DEVICE

Subcutaneous ICD with same day discharge

Receiving a SICD and discharged the same day

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Emile Daoud, MD

    lead OTHER

Principal Investigators

  • Toshimasa Okabe, MD · Ohio State University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2019-04-12
Completion
2019-04-12
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03504839 on ClinicalTrials.gov