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OpenTrials
Completed

NCT Number: NCT03073668

Pericardial Resection to Treat Heart Failure

The researchers are doing this study to find out whether there will be less increase in cardiac filling pressure after the surgeon opens the pericardium (the membrane around the heart) than when the pericardium is intact. The researchers want to see whether opening the pericardium is an effective way to reduce the blood filling pressures in the heart.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

This study will enroll patients with risk factors for LV diastolic dysfunction, either coronary artery disease or aortic stenosis, who are already undergoing cardiac surgery for clinical purposes (e.g. coronary artery bypass grafting or valvular heart disease).

Hemodynamic tests will be performed using standard clinical resources used as part of routine care in this setting, including pulmonary artery (PA) catheterization. After obtaining written informed consent, patients will undergo induction with general anesthesia as per clinical practice. The chest will be open but pericardium left intact. Cardiac hemodynamics (PA wedge pressure, PAWP; PA pressure, PAP, right atrial pressure, RAP) will be measured using PA catheter already in place at rest, and then during conditions of increased cardiac preload, induced by passive leg elevation and saline bolus (300 ml administered over 1-2 minutes).

The surgical team will then perform anterior pericardiotomy, with removal of pericardial restraint similar to our percutaneous approach but using currently-available surgical tools. This will not be a complete pericardiectomy but rather a limited anterior incision to gain access to the heart for surgical exposure (standard care).

The surgical team will then repeat hemodynamic assessments at rest and with acute volume loading (leg raise + saline) in exactly the same manner as with the pericardium intact. Our hypothesis is that as compared to pericardium intact, the increase in PAWP with volume loading will be reduced following opening of the pericardium.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion

  • >17 years old
  • Subjects having open sternotomy for either aortic valve stenosis or coronary artery bypass grafting (or both)
  • Provide informed consent Exclusion
  • <18 years old

Treatment and study plan

Anterior pericardiotomy

Procedure

The surgical team will perform anterior pericardiotomy. This will not be a complete pericardiectomy but rather a limited anterior incision to gain access to the heart for surgical exposure.

Saline

Drug

During the measurement of cardiac hemodynamic tests, a saline bolus of 300 ml will be administered over 1-2 minutes.

Primary outcomes

  1. Change in Pulmonary Artery Wedge Pressure (PAWP)

    Time frame: Baseline, approximately 1 hour

    Patients will undergo induction with general anesthesia, and at baseline the chest will be open, but pericardium left intact. Cardiac hemodynamics will be measured using the Pulmonary Artery Catheter already in place. The surgical team will then perform anterior pericardiotomy, with removal of pericardial restraint, and cardiac hemodynamics will be measured again.

Secondary outcomes

  1. Change in Pulmonary Artery Pressure (PAP)

    Time frame: Baseline, approximately 1 hour

    Patients will undergo induction with general anesthesia, and at baseline the chest will be open, but pericardium left intact. Cardiac hemodynamics will be measured using the Pulmonary Artery Catheter already in place. The surgical team will then perform anterior pericardiotomy, with removal of pericardial restraint, and cardiac hemodynamics will be measured again.

  2. Change in Right Arterial Pressure (RAP)

    Time frame: Baseline, approximately 1 hour

    Patients will undergo induction with general anesthesia, and at baseline the chest will be open, but pericardium left intact. Cardiac hemodynamics will be measured using the Pulmonary Artery Catheter already in place. The surgical team will then perform anterior pericardiotomy, with removal of pericardial restraint, and cardiac hemodynamics will be measured again.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

The Effects of Pericardiotomy on Diastolic Reserve in Humans

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Mar 8, 2017
Registry last updated
May 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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