Recruiting

Observational Study

Sponsor:

Oregon Health and Science University

Code:

NCT06087497

Conditions

Atrial Fibrillation

Atrial Flutter

Supraventricular Tachycardia

Syncope

Ventricular Tachycardia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Early mobilization

Study Details

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

Study ID

NCT06087497

Start date

Jan 1, 2024

Status verified date

Apr, 2024

Completion date

May 1, 2025

Anticipated

Primary completion date

Dec 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1 hour bedrest

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.

no intervention: 4 hour bedrest

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

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)

Primary outcome measure

  • Patient satisfaction [ Time Frame: At the time of discharge ]

Central Contacts and Locations

Central contacts

Adarsh Katamreddy, MD

503 494 7400katamred@ohsu.edu

Charles Henrikson, MD

503 494 7400henrikso@ohsu.edu

Locations

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Adarsh Katamreddy, MD

503-494-7400katamred@ohsu.edu

Charles Henrikson, MD

503 494 7400henrikso@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Apr 15, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2024-04-15.