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Behavioural Intervention

Early Mobilization for Heart Procedure Recovery (ZEBRA Trial)

N/A
Recruiting
Led By Charles Henrikson, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presenting for procedure in the EP lab for atrial flutter
Presenting for procedure in the EP lab for diagnostic EP study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the time of discharge
Awards & highlights

ZEBRA Trial Summary

This trial tests if early mobilization after a heart procedure can lead to higher patient satisfaction & earlier hospital discharge.

Who is the study for?
This trial is for adults aged 18-99 who are undergoing heart procedures like atrial fibrillation/flutter treatment, supraventricular tachycardia treatment, or getting a Watchman device. It's not for those who can't consent, have certain types of arterial access, need large sheaths (>16Fr) for their procedure, have a BMI over 40, or are having lead-extraction.Check my eligibility
What is being tested?
The study tests if early mobilization (moving around sooner) after the Z stitch procedure leads to better patient satisfaction and possibly earlier hospital discharge. Participants will be randomly assigned to either one hour or four hours of bedrest post-procedure to compare outcomes.See study design
What are the potential side effects?
Since this trial involves early movement rather than medication, side effects may include discomfort at the procedure site when moving earlier or potential complications related to reduced rest after cardiac procedures.

ZEBRA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am going to the EP lab for an atrial flutter procedure.
Select...
I am scheduled for a diagnostic heart rhythm test in the EP lab.
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I am scheduled for a procedure to manage my heart's rhythm.
Select...
I am scheduled for a procedure to place a Watchman device.

ZEBRA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days from the procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days from the procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient satisfaction
Secondary outcome measures
Complications

ZEBRA Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 1 hour bedrestExperimental Treatment1 Intervention
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.
Group II: 4 hour bedrestActive Control1 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.

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
974 Previous Clinical Trials
7,385,712 Total Patients Enrolled
Charles Henrikson, MDPrincipal InvestigatorOregon Health and Science University
5 Previous Clinical Trials
10,967 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research encompass seniors over the age of eighty-five?

"This research initiative is seeking participants who are aged 18 or above, yet below 99 years old."

Answered by AI

How many participants has this clinical trial enlisted thus far?

"Indeed, the data hosted on clinicaltrials.gov confirms that this medical study, initially posted on October 10th 2023, is actively seeking participants. To date 200 patients must be recruited from one research centre."

Answered by AI

Is it possible for me to take part in this medical experiment?

"For consideration in this investigation, participants must have fainting and be between 18-99 years of age. The research team is seeking to enrol a total of 200 individuals."

Answered by AI

Are there any available slots left in this investigation for participants?

"According to clinicaltrials.gov, this research endeavour is still enlisting participants; the trial was first published on October 10th 2023 and has been recently updated as of December 10th 2023."

Answered by AI

Who else is applying?

What site did they apply to?
Oregon Health and Science University
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I have. A upcoming. Heart. Ablation catheter procedure. In two weeks. Have had. Psvt. For. Along. Time.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
The Z Stitch Early Bed Rest Assessment Study
Charles Henrikson, MD 2024. "The Z Stitch Early Bed Rest Assessment Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06087497.
All > Vancouver
~127 spots leftby Dec 2024
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