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Procedure

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 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

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: Left Posterior Pericardiotomy GroupExperimental Treatment1 Intervention
The surgeon will perform a left posterior pericardiotomy during the patient's cardiac surgery.
Group II: No Posterior Pericardiotomy GroupActive Control1 Intervention
The surgeon will not perform a posterior pericardiotomy during the patient's cardiac surgery.

Find a Location

Who is running the clinical trial?

McMaster UniversityOTHER
918 Previous Clinical Trials
2,614,893 Total Patients Enrolled
1 Trials studying Atrial Flutter
1,500 Patients Enrolled for Atrial Flutter
Population Health Research InstituteLead Sponsor
164 Previous Clinical Trials
717,114 Total Patients Enrolled
2 Trials studying Atrial Flutter
3,959 Patients Enrolled for Atrial Flutter
Hamilton Health Sciences CorporationOTHER
377 Previous Clinical Trials
338,529 Total Patients Enrolled
1 Trials studying Atrial Flutter
3,209 Patients Enrolled for Atrial Flutter
Weill Medical College of Cornell UniversityOTHER
1,092 Previous Clinical Trials
1,153,386 Total Patients Enrolled
Sigrid SandnerPrincipal InvestigatorMedical University Vienna
Björn RedforsPrincipal InvestigatorGöteborg University
1 Previous Clinical Trials
50 Total Patients Enrolled
Richard WhitlockPrincipal InvestigatorPopulation Health Research Institute
2 Previous Clinical Trials
2,000 Total Patients Enrolled
Emilie Belley-CôtéPrincipal InvestigatorPopulation Health Research Institute
2 Previous Clinical Trials
2,000 Total Patients Enrolled
Mario GaudinoPrincipal InvestigatorWeill Medical College of Cornell University
~933 spots leftby Sep 2027
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