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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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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

    June 16, 2021

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: July 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: June 16, 2021
  • Last Verified: June 2021
  • 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