Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure

TtP: Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure (Transform the Practice)

Researchers are studying the safety and efficacy of a minimally invasive treatment called a pericardiotomy, which creates a small opening in the sac that surrounds the heart. Researchers will test the short and long term effects of this procedure by monitoring subjects heart function and symptoms.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Procedure: Pericardiotomy

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Age ≥ 30 years
• Symptoms of severe dyspnea (III-IV) without evidence of a non-cardiac or ischemic explanation for dyspnea
• EF of > or = 50% determined on most recent imaging study within the preceding 5 years, with no change in clinical status suggesting potential for deterioration in systolic function

• One of the following:

  • Previous hospitalization for HF with radiographic evidence (pulmonary venous hypertension, vascular congestion, interstitial edema, pleural effusion) of pulmonary congestion or
  • Catheterization documented elevated filling pressures at rest (PCWP ≥15 or LVEDP ≥18) or with exercise (PCWP ≥25) or
  • Elevated NT-proBNP (>400 pg/ml) or BNP(>200 pg/ml) or
  • Echo evidence of diastolic dysfunction/elevated filling pressures manifest by medial E/e' ratio≥15 and/or left atrial enlargement and chronic treatment with a diuretic for signs or symptoms of heart failure

• Heart failure is primary factor limiting activity as indicated by answering # 2 to the following question: My ability to be active is most limited by:

  • Joint, foot, leg, hip or back pain
  • Shortness of breath and/or fatigue and/or chest pain
  • Unsteadiness or dizziness
  • Lifestyle, weather, or I just don't like to be active
  • Ambulatory (not wheelchair / scooter dependent)

Exclusion Criteria

• Recent (< 1 month) hospitalization for heart failure
• Left or right ventricular dilatation noted on cardiac imaging study prior to enrollment (either echocardiography or MRI).
• Any hemoglobin (Hgb) < 8.0 g/dl within 30 days prior to randomization
• Any GFR < 20 ml/min/1.73 m2 within 30 days prior to randomization
• Significant alternative cause of dyspnea such as severe chronic obstructive pulmonary disease that is a primary contributor to symptoms in the opinion of the investigator
• Ischemia thought to contribute to dyspnea in the opinion of the investigator
• Acute coronary syndrome within 3 months defined by electrocardiographic (ECG) changes and biomarkers of myocardial necrosis (e.g., troponin) in an appropriate clinical setting (chest discomfort or anginal equivalent)
• PCI, coronary artery bypass grafting, or new biventricular pacing within past 3 months
• Obstructive hypertrophic cardiomyopathy
• Known infiltrative cardiomyopathy (amyloid)
• Pericardial disease (constriction, pericarditis, tamponade)
• Active myocarditis
• Complex congenital heart disease
• Active collagen vascular disease
• Significant valvular heart disease (greater than mild stenosis or greater than moderate regurgitant lesions)
• Acute or chronic severe liver disease as evidenced by any of the following: encephalopathy, variceal bleeding, INR > 1.7 in the absence of anticoagulation treatment
• Terminal illness (other than HF) with expected survival of less than 1 year
• Enrollment or planned enrollment in another therapeutic clinical trial in next 3 months.
• Inability to comply with planned study procedures
• Pregnancy or breastfeeding mothers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects with Heart Failure with Preserved Ejection Fraction; Subjects with Heart Failure with Preserved Ejection Fraction (HFpEF) will receive a minimally invasive treatment called a pericardiotomy.	Procedure: Pericardiotomy; The minimally invasive procedure that creates a small opening in the sac that surrounds the heart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiac and Cerebrovascular Events	The number of major cardiac and cerebrovascular events reported.	6 months
Change in left ventricular filling pressures during volume loading	The number of subjects to demonstrate an increase in pulmonary capillary wedge pressure in response to volume loading after pericardiotomy vs. prior to pericardiotomy.	baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life	Measured using Kansas City Cardiomyopathy Questionnaire (KCCQ)	baseline, 6 months
Change in exercise capacity	Measured by Cardiopulmonary Exercise Testing	baseline, 6 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Barry A Borlaug, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): October 15, 2020
• Study Completion (Actual): October 15, 2020

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 18, 2019
• First Posted (Actual): April 22, 2019

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 18-010106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No