| Condition or disease | Intervention/treatment | Phase | 
|---|---|---|
| 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 | 
|---|---|
| 
          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. 
 | 
              
| 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 | |||||
|---|---|---|---|---|---|
| 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   | 
            
  | 
    ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures  ICMJE   | 
            
  | 
    ||||
| 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  | 
    ||||
| Condition ICMJE | Heart Failure | ||||
| Intervention ICMJE | Procedure: Pericardiotomy
 The minimally invasive procedure that creates a small opening in the sac that surrounds the heart. 
             | 
    ||||
| 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 
             | 
    ||||
| Publications * | Not Provided | ||||
| 
         * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.  | 
    |||||
| 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 
  | 
    ||||
| Sex/Gender ICMJE | 
  | 
    ||||
| 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 | 
  | 
    ||||
| IPD Sharing Statement ICMJE | 
  | 
    ||||
| Responsible Party | Barry Borlaug, Mayo Clinic | ||||
| Study Sponsor ICMJE | Mayo Clinic | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | 
  | 
    ||||
| 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  | 
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