TtP: Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure (Transform the Practice)

Mayo Clinic1 site in 1 country4 target enrollmentMay 1, 2019

ConditionsHeart Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Mayo Clinic
Enrollment: 4
Locations: 1
Primary Endpoint: Major Adverse Cardiac and Cerebrovascular Events
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 1, 2019

End Date

October 15, 2020

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Barry Borlaug

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Major Adverse Cardiac and Cerebrovascular Events

Time Frame: 6 months

The number of major cardiac and cerebrovascular events reported.

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.