← Back to Search

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

Must not have

Patients with a BMI > 40

Lead-extraction patients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the time of discharge

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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.

Select...

I am scheduled for a procedure to manage my heart's rhythm.

Select...

I am scheduled for a procedure to place a Watchman device.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My BMI is over 40.

Select...

I am scheduled for or have had a lead extraction procedure.

Select...

I am unable or unwilling to give consent for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days from the procedure

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient satisfaction

Secondary study objectives

Complications

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 7Eligibility criteria met