Assessing early mobilization after Z stitch procedures for heart treatments
The Z Stitch Early Bed Rest Assessment Study
This study tests if getting up and moving sooner after a heart procedure helps patients feel more satisfied with their care compared to staying in bed longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 2 sites (Portland, Oregon and 1 other locations) |
| Trial ID | NCT06087497 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of early mobilization on patient satisfaction following the Z stitch procedure in patients undergoing various heart-related treatments. Participants will be randomly assigned to either one hour or four hours of bed rest after the procedure. The primary focus is to determine if earlier movement leads to higher satisfaction scores without compromising safety. Secondary outcomes include monitoring for complications, pain management, healthcare costs, and patient outcomes within 30 days post-procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-99 undergoing specific heart procedures such as atrial fibrillation treatment or Watchman device placement.
Not a fit: Patients who refuse consent, have arterial access, or have a BMI over 40 may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance patient satisfaction and potentially reduce hospital stay durations.
How similar studies have performed: While the Z stitch method is a novel approach, similar studies on early mobilization have shown promising results in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Portland, Oregon and 1 other locations
- Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
- Portland VA Medical Center — Portland, Oregon, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Charles Henrikson, MD — Oregon Health and Science University
- Study coordinator: Adarsh Katamreddy, MD
- Email: katamred@ohsu.edu
- Phone: 503 494 7400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.