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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/15/2021.

Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure

Clinicaltrials.gov identifier NCT03923673

Recruitment Status Active, not recruiting

First Posted April 22, 2019

Last update posted December 6, 2019

Study Description

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.

  • Condition or Disease:Heart Failure
  • Intervention/Treatment: Procedure: Pericardiotomy
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 4 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: TtP: Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure (Transform the Practice)
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: May 2021
  • Estimated Study Completion Date: May 2022
Arms and interventions
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.
Outcome Measures
  • Primary Outcome Measures: 1. Major Adverse Cardiac and Cerebrovascular Events [ Time Frame: 6 months ]
    The number of major cardiac and cerebrovascular events reported.
  • 2. Change in left ventricular filling pressures during volume loading [ Time Frame: baseline, 6 months ]
    The number of subjects to demonstrate an increase in pulmonary capillary wedge pressure in response to volume loading after pericardiotomy vs. prior to pericardiotomy.
  • Secondary Outcome Measures: 1. Change in Quality of Life [ Time Frame: baseline, 6 months ]
    Measured using Kansas City Cardiomyopathy Questionnaire (KCCQ)
  • 2. Change in exercise capacity [ Time Frame: baseline, 6 months ]
    Measured by Cardiopulmonary Exercise Testing
Eligibility Criteria
  • Ages Eligible for Study: 30 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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 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

Contacts and Locations
Contacts
Locations

United States, Minnesota
Mayo Clinic in Rochester
Rochester

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Barry A Borlaug, MD Mayo Clinic

More Information
  • Responsible Party: Mayo Clinic
  • ClinicalTrials.gov Identifier: NCT03923673 History of Changes
  • Other Study ID Numbers: 18-010106
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: December 6, 2019
  • Last Verified: December 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Heart Failure