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The Z Stitch Early Bed Rest Assessment Study (ZEBRA)

Primary Purpose

Atrial Fibrillation, Atrial Flutter, Supraventricular Tachycardia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early mobilization
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Presenting for procedure in the EP lab for: Atrial fibrillation Atrial flutter Supraventricular tachycardia Diagnostic EP study Atrioventricular node ablation Watchman device placement Exclusion Criteria: Those who refuse or are unable to consent. Cases involving arterial access. Cases involving access with a >16Fr sheath (i.e., no leadless pacer patients). Patients with a BMI > 40. Lead-extraction patients.

Sites / Locations

  • Oregon Health and Science UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1 hour bedrest

4 hour bedrest

Arm Description

One hour of bedrest, elevate head of bed to 30 degrees at 30 minutes, ambulate at 60 minutes, Z stitches out at 4 hours, eligible for discharge (if appropriate) at 4.5 hours.

Four hours of bedrest, elevate head of bed to 30 degrees at 2 hours, Z stitches out at 4 hours, ambulate at 4 hours, eligible for discharge at 4.5 hours.

Outcomes

Primary Outcome Measures

Patient satisfaction
Patient satisfaction will be assessed with a survey prior to discharge.

Secondary Outcome Measures

Complications
Rates of hematomas, Other bleeding complications, Other complications, Use of pain medications, Cost, 30 day outcomes, Readmission/ED visit for groin concerns within 30 days.

Full Information

First Posted
October 12, 2023
Last Updated
October 12, 2023
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT06087497
Brief Title
The Z Stitch Early Bed Rest Assessment Study
Acronym
ZEBRA
Official Title
The Z Stitch Early Bed Rest Assessment Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2023 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to understand the effects of early mobilization after a Z stitch procedure in patients undergoing certain heart-related treatments. We want to find out if allowing patients to move around sooner after their procedure can improve their satisfaction and potentially lead to earlier discharge from the hospital. Type of Study: Clinical Trial Participant Population/Health Conditions: Patients aged 18-99 undergoing specific heart procedures such as atrial fibrillation treatment, atrial flutter treatment, supraventricular tachycardia treatment, diagnostic electrophysiology studies, AV node ablation, or Watchman device placement. Main Questions: Does early mobilization (getting up and moving around sooner) after the Z stitch procedure improve patient satisfaction? Participants will be divided into two groups, and researchers will compare those who have one hour of bedrest with those who have four hours of bedrest after the Z stitch procedure. We want to see if the shorter bedrest period leads to higher patient satisfaction.
Detailed Description
The ZEBRA study, or the Z stitch Early Bed Rest Assessment study, aims to assess the impact of early mobilization following Z stitch placement on patient satisfaction and safety in the context of venous vascular access management during Electrophysiology (EP) procedures. The study hypothesizes that allowing patients to move sooner after Z stitch placement will lead to higher patient satisfaction scores without compromising safety. The primary endpoint for evaluation is patient satisfaction, gauged through survey-based scores, while secondary endpoints encompass a range of factors including hematoma development, bleeding-related complications, the use of pain medications, associated healthcare costs, 30-day patient outcomes, actual post-procedure ambulation time, and instances of hospital readmissions or emergency department visits within the initial 30 days post-procedure. Historically, venous vascular access has been managed by employing direct manual pressure for hemostasis following sheath removal, which necessitates a prolonged period of bed rest for the patient. However, a recent advancement, termed the "Z stitch" method, achieves hemostasis by placing a Z-shaped stitch around the vascular access site, providing continuous pressure and allowing for safer sheath removal without the need for anticoagulation reversal. Despite the effectiveness of the Z stitch, current practice still involves extended bed rest post-procedure. This randomized clinical trial aims to fill the existing knowledge gaps by approaching eligible patients ahead of their procedures or during the consent process. Patients will be randomized 1:1 to two distinct protocols: one involving one hour of bed rest post-procedure, followed by ambulation at 60 minutes and Z stitch removal at 4 hours; and the other entailing 4 hours of bed rest, with Z stitch removal and ambulation at the same 4-hour mark. Compression time at the Z stitch placement will also be stratified based on the sheath size and whether systemic anticoagulation is used. Assessments for groin hematoma and patient satisfaction surveys will be completed prior to discharge, with a 30-day phone follow-up to evaluate longer-term outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Atrial Flutter, Supraventricular Tachycardia, Syncope, Ventricular Tachycardia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1 hour bedrest
Arm Type
Experimental
Arm Description
One hour of bedrest, elevate head of bed to 30 degrees at 30 minutes, ambulate at 60 minutes, Z stitches out at 4 hours, eligible for discharge (if appropriate) at 4.5 hours.
Arm Title
4 hour bedrest
Arm Type
No Intervention
Arm Description
Four hours of bedrest, elevate head of bed to 30 degrees at 2 hours, Z stitches out at 4 hours, ambulate at 4 hours, eligible for discharge at 4.5 hours.
Intervention Type
Other
Intervention Name(s)
Early mobilization
Intervention Description
Z stitch placement is standard of care to achieve vascular hemostasis after EP procedures which is followed by 4 hours of bedrest. In this study, we will compare patient satisfaction and bleeding complications with a shorter bedrest (1 hour instead of 4 hours)
Primary Outcome Measure Information:
Title
Patient satisfaction
Description
Patient satisfaction will be assessed with a survey prior to discharge.
Time Frame
At the time of discharge
Secondary Outcome Measure Information:
Title
Complications
Description
Rates of hematomas, Other bleeding complications, Other complications, Use of pain medications, Cost, 30 day outcomes, Readmission/ED visit for groin concerns within 30 days.
Time Frame
30 days from the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presenting for procedure in the EP lab for: Atrial fibrillation Atrial flutter Supraventricular tachycardia Diagnostic EP study Atrioventricular node ablation Watchman device placement Exclusion Criteria: Those who refuse or are unable to consent. Cases involving arterial access. Cases involving access with a >16Fr sheath (i.e., no leadless pacer patients). Patients with a BMI > 40. Lead-extraction patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adarsh Katamreddy, MD
Phone
503 494 7400
Email
katamred@ohsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Charles Henrikson, MD
Phone
503 494 7400
Email
henrikso@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Henrikson, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adarsh Katamreddy, MD
Phone
503-494-7400
Email
katamred@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Charles Henrikson, MD
Phone
503 494 7400
Email
henrikso@ohsu.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data (IPD) with other researchers

Learn more about this trial

The Z Stitch Early Bed Rest Assessment Study

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