The Z Stitch Early Bed Rest Assessment Study

NCT06087497 | Recruiting

• 1 other identifier: STUDY00025985
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Atrial Fibrillation; Atrial Flutter; Supraventricular Tachycardia; Syncope; Ventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction

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

  At the time of discharge

Secondary Outcomes (1)

• Complications

  30 days from the procedure

Study Arms (2)

1 hour bedrest

EXPERIMENTAL

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.

Other: Early mobilization

4 hour bedrest

NO INTERVENTION

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.

Interventions

Early mobilization OTHER

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)

1 hour bedrest

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presenting for procedure in the EP lab for:
• Atrial fibrillation
• Atrial flutter
• Supraventricular tachycardia
• Diagnostic EP study
• Atrioventricular node ablation
• Watchman device placement

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (2)

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

Portland VA Medical Center

Portland, Oregon, 97239, United States

NOT YET RECRUITING

MeSH Terms

Conditions

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

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Charles Henrikson, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adarsh Katamreddy, MD

CONTACT

503 494 7400; katamred@ohsu.edu

Charles Henrikson, MD

CONTACT

503 494 7400; henrikso@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Electrophysiology

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 17, 2023
• Study Start: January 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)