Clinical trial NCT06087497: The Z Stitch Early Bed Rest Assessment Study
Official title: The Z Stitch Early Bed Rest Assessment Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Atrial Flutter
Supraventricular Tachycardia
Syncope
Ventricular Tachycardia
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

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.

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.

Primary outcomes:
measure: Patient satisfaction
timeFrame: At the time of discharge
Secondary outcomes:
measure: Complications
timeFrame: 30 days from the procedure
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Charles Henrikson, MD
role: PRINCIPAL_INVESTIGATOR
References: