Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure

NCT03923673 | Completed

• 1 other identifier: 18-010106
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Quality of Life

  baseline, 6 months

• Change in exercise capacity

  baseline, 6 months

Study Arms (1)

Subjects with Heart Failure with Preserved Ejection Fraction

EXPERIMENTAL

Subjects with Heart Failure with Preserved Ejection Fraction (HFpEF) will receive a minimally invasive treatment called a pericardiotomy.

Procedure: Pericardiotomy

Interventions

Pericardiotomy PROCEDURE

The minimally invasive procedure that creates a small opening in the sac that surrounds the heart.

Subjects with Heart Failure with Preserved Ejection Fraction

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Heart Failure

Interventions

Pericardiectomy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Barry A Borlaug, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 22, 2019
• Study Start: May 1, 2019
• Primary Completion: October 15, 2020
• Study Completion: October 15, 2020
• Last Updated: August 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)