The Z Stitch Early Bed Rest Assessment Study

Atrial Fibrillation Clinical Trial

— ZEBRA  

Official title:

The Z Stitch Early Bed Rest Assessment Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06087497
• Other study ID #: STUDY00025985
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: May 1, 2025

Study information

• Verified date: April 2024
• Source: Oregon Health and Science University
• Contact: Adarsh Katamreddy, MD
• Phone: 503 494 7400
• Email: katamred[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. The investigators 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. The investigators want to see if the shorter bedrest period leads to higher patient satisfaction.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter
• Supraventricular Tachycardia
• Syncope
• Tachycardia
• Tachycardia, Supraventricular
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Other:
• Early mobilization
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)

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon
United States	Portland VA Medical Center	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction	Patient satisfaction will be assessed with a survey prior to discharge.	At the time of discharge
Secondary	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.	30 days from the procedure