Pericardiotomy in Cardiac Surgery

Part of paid clinical trials in New York, New York.

Sponsor
Population Health Research Institute
Study ID
NCT06486636
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Left Posterior Pericardiotomy — PROCEDURE
    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 Details

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.

Key Dates

Start date
Oct 21, 2024
Status verified
Jul 2025
Primary completion
Sep 1, 2027
Completion
Sep 1, 2031

Study Design

Enrollment
1,400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Left Posterior Pericardiotomy Group
    The surgeon will perform a left posterior pericardiotomy during the patient's cardiac surgery.
  • No Intervention: No Posterior Pericardiotomy Group
    The surgeon will not perform a posterior pericardiotomy during the patient's cardiac surgery.

Primary Outcome Measure

In-hospital post-operative atrial fibrillation [ Time Frame: Within 5 days after index cardiac surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10065
Dr. Mario Gaudino, MD, PhD
[email protected]
212-746-1815

Find similar trials in New York, NY

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
Weill Cornell Medicine· New York, NY

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