Pericardiotomy for Cardiovascular Disease (PRINCE Trial)

N/A

Recruiting

Led By Sigrid Sandner

Research Sponsored by Population Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Requiring surgical intervention on the proximal aorta, cardiac valves, and/or coronary arteries

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over the duration of the follow-up (mean follow-up of 5 years)

Awards & highlights

No Placebo-Only Group

Summary

"This trial is investigating the use of posterior pericardiotomy in patients without a history of atrial fibrillation or flutter who are having cardiac surgery on an international scale."

Who is the study for?

This trial is for adults over 18 who need heart surgery on the aorta, valves, or coronary arteries and can give informed consent. It's not for those with a history of atrial fibrillation or flutter.

What is being tested?

The PRINCE trial is testing if doing a left posterior pericardiotomy during cardiac surgery can prevent complications like atrial fibrillation. Patients are randomly chosen to either get this procedure or not.

What are the potential side effects?

Potential side effects may include discomfort at the incision site, bleeding, infection risk from the additional surgical step, and possible impacts on heart function.

Eligibility Criteria

Inclusion Criteria

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

Select...

I need surgery on my heart or the main blood vessel coming from it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over the duration of the follow-up (mean follow-up of 5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over the duration of the follow-up (mean follow-up of 5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and over the duration of the follow-up (mean follow-up of 5 years) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Hierarchical composite of all-cause death, ischemic stroke, systemic arterial embolism, unplanned hospital visit/readmission for cardiac reasons, and atrial fibrillation.

In-hospital post-operative atrial fibrillation

Secondary study objectives

Death

Hospital readmission or unplanned hospital visit

Ischemic stroke or systemic arterial embolism

+4 more

Other study objectives

Number of patients requiring re-operation for bleeding

Number of patients with cardiac tamponade

Number of patients with esophageal injuries

+2 more