RECRUITING

The PeriCut Catheter System Early Feasibility Study (REIMAGINE-HFpEF)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The PeriCut early feasibility study will evaluate the safety and feasibility of successfully performing a minimally invasive pericardiotomy in patients with heart failure with preserved ejection fraction using the PeriCut Catheter System.

Official Title

Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure With Preserved Ejection Fraction - The PeriCut Catheter System Early Feasibility Study (REIMAGINE HFpEF)

Quick Facts

Study Start:2025-02-17
Study Completion:2026-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06702501

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Mark Strong
CONTACT
6512694640
Mark@Heartfailureinc.com

Principal Investigator

Dr. Barry Borlaug
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Heart Failure Solutions, Inc.

  • Dr. Barry Borlaug, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-17
Study Completion Date2026-06-01

Study Record Updates

Study Start Date2025-02-17
Study Completion Date2026-06-01

Terms related to this study

Keywords Provided by Researchers

  • Heart Failure Solutions
  • Heart Failure with Preserved Ejection Fraction
  • PeriCut
  • Pericardiotomy

Additional Relevant MeSH Terms

  • Heart Failure With Preserved Ejection Fraction