Condition or disease | Intervention/treatment | Phase |
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Heart Failure | Procedure: Pericardiotomy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 4 participants |
Allocation: | N/A |
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 1, 2019 |
Estimated Primary Completion Date : | May 2021 |
Estimated Study Completion Date : | May 2022 |
Arm | Intervention/treatment |
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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.
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Procedure: Pericardiotomy
The minimally invasive procedure that creates a small opening in the sac that surrounds the heart.
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Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
One of the following:
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:
Exclusion Criteria
United States, Minnesota | |
Mayo Clinic in Rochester | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Barry A Borlaug, MD | Mayo Clinic |
Tracking Information | |||||
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First Submitted Date ICMJE | April 16, 2019 | ||||
First Posted Date ICMJE | April 22, 2019 | ||||
Last Update Posted Date | January 28, 2021 | ||||
Actual Study Start Date ICMJE | May 1, 2019 | ||||
Estimated Primary Completion Date | May 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure | ||||
Official Title ICMJE | TtP: Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure (Transform the Practice) | ||||
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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Heart Failure | ||||
Intervention ICMJE | Procedure: Pericardiotomy
The minimally invasive procedure that creates a small opening in the sac that surrounds the heart.
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Study Arms ICMJE | 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.
Intervention: Procedure: Pericardiotomy
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
4 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | May 2022 | ||||
Estimated Primary Completion Date | May 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria
Exclusion Criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 30 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03923673 | ||||
Other Study ID Numbers ICMJE | 18-010106 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Barry Borlaug, Mayo Clinic | ||||
Study Sponsor ICMJE | Mayo Clinic | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Mayo Clinic | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |