Atrial FibrillationPRINCENCT06486636
Pericardiotomy in Cardiac Surgery
A study testing Left Posterior Pericardiotomy in people with Atrial Fibrillation and Atrial Flutter, run by Population Health Research Institute at 19 sites in 5 countries.
Trial summary
PRINCE is an international, multicentre, randomized controlled trial of posterior pericardiotomy in patients without a history of atrial fibrillation (AF) or flutter undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter, Cardiac Events
- What is being tested?
- Left Posterior Pericardiotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 19 sitesin 5 countries
- Study dates
- 21 Oct 2024to 1 Sep 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients greater than or equal to 18 years of age
- Requiring surgical intervention on the proximal aorta, cardiac valves, and/or coronary arteries
- Able to provide informed consent
Who cannot join
- History of atrial fibrillation or flutter
- Cardiac surgery procedures not included in the inclusion criteria (planned ventricular assistance device, planned aortic arch, transplantation surgery)
- Prior cardiac surgery requiring opening of the pericardium
- Previous surgical instrumentation of the left pleural cavity
- Patient undergoing minimally invasive cardiac surgery
Trial locations and contacts
19 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
PRINCE Coordinators contact
19 sites in 5 countries
Canada7 sites, 4 recruiting
- Recruiting
Nova Scotia Health Authority - Halifax Infirmary
Halifax, Nova Scotia, B3H3A7
Dr. Roberto Riberio, 902-473-3808, roberto.riberio@nshealth.ca
- Active, not recruiting
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
- Active, not recruiting
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
- Active, not recruiting
(CHUM) Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X0C1
- Recruiting
McGill University Health Centre - Royal Victoria Hospital
Montreal, Quebec, H4A 3J1
Dr. Kevin Lachapelle, 514-934-1934 ext. 36605, kevin.lachapelle@mcgill.ca
- Recruiting
Hôpital du Sacré-Cœur-de-Montréal
Montreal, Quebec, H4J1C5
Dr. Hugues Jeanmart, (514) 338-2050, hugues.jeanmart.med@ssss.gouv.qc.ca
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B1W8
Dr. David Mazer, 416-864-5825, david.mazer@unityhealth.to
Italy5 sites, 5 recruiting
- Recruiting
Policlinico Foggia
Foggia, Foggia, 71122
Dr. Domenico Paparella, 39 008-173-6145, domenico.paparella@unifg.it
- Recruiting
University of Foggia, Policlinico Foggia
Foggia, Foggia, 71122
Prof. Domenico Paparella, MD, PHD, +39 0881 736145, domenico.paparella@unifg.it
- Recruiting
IRCSS Policlinico San Donato
San Donato Milanese, Milano, 20097
Dr. Alessandra Sala, 39 345-783-7776, alessandra.sala@grupposandonato.it
- Recruiting
Maria Pia Hospital
Turin, Turin, 10132
Dr. Marco Agostini, 00390171642954, agostinimarco59@gmail.com
- Recruiting
San Bortolo Hospital
Vicenza, Vincenza, 36100
Dr. Giovanni Domenico Cresce, 39 044-475-2763, gd.cresce@yahoo.it
United States3 sites, 2 recruiting
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Dr. Lorraine Cornwell, 713-794-8040, cornwell@bcm.edu
- Recruiting
University of Louisville
Louisville, Kentucky, 40202
Dr. Mark Slaughter, 502-588-7600, mark.slaughter@louisville.edu
- Active, not recruiting
Weill Cornell Medicine
New York, New York, 10065
Austria2 sites, 2 recruiting
- Recruiting
Medical University of Innsbruck
Innsbruck, Tyrol, 6020
Dr. Nikolas Bonaros, 43 512-504-80764, nikolaos.bonaros@i-med.ac.at
- Recruiting
Medical University Vienna
Vienna, State of Vienna, 1090
Dr. Sigrid Sandner, MD, +43 (0)1 40400-69895, sigrid.sandner@meduniwien.ac.at
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario del Vinalopo
Alicante, Alicante, 03293
Dr. Jose Albors, 0034636234383, jalbors@vinaloposalud.com
- Recruiting
Hospital Clinico San Carlos
Madrid, Madrid, 28040
Dr. Paula Campelos, 34 699-608-977, paulacampelos@hotmail.com
About this study
Official title: Pericardiotomy in Cardiac Surgery Trial
PRINCE is an international, multicentre, randomized controlled trial of posterior pericardiotomy in patients without a history of atrial fibrillation (AF) or flutter undergoing cardiac surgery.
Read the detailed description
Approximately 30% of cardiac surgical patients develop post-operative atrial fibrillation (POAF). Its incidence varies depending on the type of cardiac operation. POAF is associated with short- and long-term adverse events, including mortality, stroke, and heart failure. POAF has also been significantly associated with unplanned hospitalization for heart failure.
During cardiac surgery, pericardial fluid tends to collect posterior to the left atrium. Even small amounts of fluid may trigger atrial arrhythmias. A posterior left pericardiotomy is a surgical procedure that involves cauterizing an opening between the left inferior pulmonary vein and the diaphragm. This procedure may allow for more prolonged drainage of the pericardial fluid into the left pleural space. Recent research evidence found that posterior pericardiotomy was associated with a significantly lower incidence of POAF.
The existing data on posterior pericardiotomy is promising for a reduction in POAF. However, no high-quality study has demonstrated that this reduction improves clinical outcomes in the years after cardiac surgery. The PRINCE trial's long-term follow-up of patients randomized to left posterior pericardiotomy could conclusively demonstrate whether the relationship of POAF to post-discharge clinical outcomes is causal and modifiable.
The PRINCE trial will evaluate the effectiveness and safety of posterior left pericardiotomy in preventing POAF and improving post-discharge clinical outcomes in a broad spectrum of cardiac surgery patients.
The intervention under investigation is left posterior pericardiotomy which is compared to no posterior pericardiotomy during cardiac surgery. The early co-primary outcome is in-hospital POAF, and the late co-primary outcome is the hierarchical composite of time to all-cause death, time to ischemic stroke, time to systemic arterial embolism, time to unplanned hospital visit/readmission for cardiac reasons, and time to atrial fibrillation after 30 days, evaluated over the duration of follow-up.
The study will enrol 1400 patients from 30 centres, globally. Follow-up visits will be performed in person or by telephone 1 and 6 months post-randomization (+7 days), and then every 6 months (+30 days) until an average follow-up of 5 years for the study participants (estimated to be 4 years after completion of enrolment).
- Conditions
- Atrial Fibrillation, Atrial Flutter, Cardiac Events
- Being tested
- Left Posterior Pericardiotomy
- Keywords
- Pericardiotomy, Cardiac Surgery, Hospital Readmission, Post-Operative Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Posterior PericardiotomyProcedure or surgery
The surgeon will perform a left posterior pericardiotomy while the patient is on cardiopulmonary bypass. A soft channel drain will be put into place at an angle directed toward the posterior pericardium. The surgeon will grasp the pericardium and use cautery to make a 4- to 5-cm opening between the left inferior pulmonary vein and the diaphragm. The previously prepared channel drain is cut to the desired length and placed through the pericardiotomy along the diaphragm and into the pleural space.
| Study group | Role | What they receive |
|---|---|---|
| Left Posterior Pericardiotomy Group | Experimental | The surgeon will perform a left posterior pericardiotomy during the patient's cardiac surgery. Receives: Procedure: Left Posterior Pericardiotomy |
| No Posterior Pericardiotomy Group | No intervention | The surgeon will not perform a posterior pericardiotomy during the patient's cardiac surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital post-operative atrial fibrillation
Number of patients with post-operative atrial fibrillation within the first 5 days postoperatively or up to hospital discharge, whichever occurs first
Measured: Within 5 days after index cardiac surgery
Hierarchical composite of all-cause death, ischemic stroke, systemic arterial embolism, unplanned hospital visit/readmission for cardiac reasons, and atrial fibrillation.
Number of patients with a composite of time to all-cause death, time to ischemic stroke, time to systemic arterial embolism, time to unplanned hospital visit/readmission for cardiac reasons, and time to atrial fibrillation after 30 days, evaluated using the win ratio (thereby accounting for the difference in importance of these outcomes).
Measured: Over the duration of the follow-up period to a common end date (mean follow-up of 5 years).
Secondary outcomes (8)
Post-operative atrial fibrillation (POAF)
Number of patients with post-operative atrial fibrillation
Measured: From index surgery completion to within 30 days of index surgery
Length of post-operative in-hospital stay
Length of time the patient in hospital after their index cardiac surgery
Measured: Over the duration of the follow-up period to a common end date (mean follow-up of 5 years).
Pericardial effusion without tamponade
Number of pericardial effusions that occur, excluding cardiac tamponade
Measured: From index surgery completion to within 30 days of index surgery
Death
Occurrence of death
Measured: From index surgery completion to within 30 days of index surgery
Ischemic stroke or systemic arterial embolism
Number of ischemic strokes or systemic arterial embolisms
Measured: From index surgery completion to within 30 days of index surgery
Hospital readmission or unplanned hospital visit
Number of hospital readmissions or unplanned hospital visits
Measured: From index surgery completion to within 30 days of index surgery
Quality of life assessed by the European quality of life index version 5D (EQ-5D-5L) questionnaire
The EQ-5D-5L consists of a descriptive system and the EQ visual analogue scale (EQ VAS) scale of 0-100 where the endpoints are labelled 'The best health you can image' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is measured on a 5 point scale: no problems, slight problems, moderate problems, severe problems and extreme problems.
Measured: Over the duration of the follow-up (mean follow-up of 5 years)
Functional abilities assessed by the SAGE (Standard Assessment of Global-Activities in the Elderly) questionnaire
Functional ability will be assessed using the SAGE questionnaire, which evaluates participants' ability to perform activities in their home and community over the previous month. The questionnaire assesses cognitive and functional activities, including attention, memory, concentration, managing finances and medications, meal preparation, transportation, mobility, dressing, transfers, and bathing/toileting. Difficulty with applicable activities is classified as none, mild, moderate, or severe. Mild difficulty is defined as minimal or occasional difficulty that does not affect the ability to perform the activity; moderate difficulty is regular difficulty that affects the ability to perform the activity, although the participant may still be able to perform it; and severe difficulty is extreme or constant difficulty, or inability to complete the activity or completion by another person because of the difficulty.
Measured: Over the duration of the follow-up (mean follow-up of 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start21 Oct 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each patient will be assigned in a blinded fashion to one of two groups (left posterior pericardiotomy or no posterior pericardiotomy) in a 1:1 ratio.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, Hamilton Health Sciences Corporation, Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Richard Whitlock, Principal investigator, Population Health Research InstituteEmilie Belley-Côté, Principal investigator, Population Health Research InstituteMario Gaudino, Principal investigator, Weill Medical College of Cornell UniversitySigrid Sandner, Principal investigator, Medical University of ViennaBjörn Redfors, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486636
- Sponsor's protocol ID
- PRINCE - 2024
- Acronym
- PRINCE
- Status last verified
- Oct 2026
- First submitted
- 13 Jun 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No