RECRUITING

Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study

Conditions

Mitral Regurgitation Tricuspid Regurgitation Valvular Heart Disease Valve Surgery Valve Repair Annuloplasty Rings Annuloplasty Bands Rigid Saddle Ring Séguin Annuloplasty Ring Tailor Annuloplasty Ring Tailor Annuloplasty Band

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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

ARB-PMCF is a multicenter, observational study of the safety and performance of Abbott annuloplasty devices used in surgical repair of mitral and tricuspid valve regurgitation. The devices included in this study are the SJM™ Rigid Saddle Ring and SJM Séguin Annuloplasty Ring, indicated for mitral valve repair, and the SJM Tailor™ Annuloplasty Ring and SJM Tailor Annuloplasty Band, indicated for mitral or tricuspid repair. Participants will be enrolled prior to undergoing mitral or tricuspid valve repair surgery including an Abbott annuloplasty implant and will complete annual follow-up visits through five years from implant. The study is being conducted to meet post-market clinical follow-up requirements of the European Union Medical Device Directives.

Official Title

Annuloplasty Rings and Band Post-Market Clinical Follow-Up (ARB-PMCF) Study

Quick Facts

Study Start:2021-02-01

Study Completion:2031-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04761120

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:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject is expected to undergo cardiac surgery in ≤90 days including at least one of the following: 1. implant of a Rigid Saddle Ring, Séguin Ring or a full Tailor Ring without cut zone removal for MR repair 2. implant of a full Tailor Ring without cut zone removal for TR repair, or 3. implant of a Tailor Band or partial Tailor Ring with cut zone removed for primary TR repair. 2. Subject's cardiac surgery will be performed by a study investigator. 3. Subject will be ≥18 years old at the time of their annuloplasty implant(s). 4. Subject provides written informed consent and agrees to comply with all required study visits and procedures.	1. Subject is below the age of legal consent in the applicable jurisdiction or otherwise lacks legal authority to provide informed consent. 2. Subject is unable to read or write or has a mental illness or disability that impairs their ability to provide written informed consent. 3. Subject is expected to have active endocarditis at the time of their Abbott annuloplasty device implant(s). 4. Subject cannot be unambiguously assigned to a treatment group due to missing data on repair indication(s) or the model and configuration (cut zone removed or not) of their Abbott annuloplasty implant(s). 5. Subject is participating in another clinical investigation including any treatment outside the investigative site's usual standard of care. 6. Subject has anomalous anatomy or medical, surgical, psychiatric or social history or conditions that, in the investigator's opinion, would limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements

Inclusion Criteria

Exclusion Criteria

1. Subject is expected to undergo cardiac surgery in ≤90 days including at least one of the following:
1. implant of a Rigid Saddle Ring, Séguin Ring or a full Tailor Ring without cut zone removal for MR repair
2. implant of a full Tailor Ring without cut zone removal for TR repair, or
3. implant of a Tailor Band or partial Tailor Ring with cut zone removed for primary TR repair.
2. Subject's cardiac surgery will be performed by a study investigator.
3. Subject will be ≥18 years old at the time of their annuloplasty implant(s).
4. Subject provides written informed consent and agrees to comply with all required study visits and procedures.

1. Subject is below the age of legal consent in the applicable jurisdiction or otherwise lacks legal authority to provide informed consent.
2. Subject is unable to read or write or has a mental illness or disability that impairs their ability to provide written informed consent.
3. Subject is expected to have active endocarditis at the time of their Abbott annuloplasty device implant(s).
4. Subject cannot be unambiguously assigned to a treatment group due to missing data on repair indication(s) or the model and configuration (cut zone removed or not) of their Abbott annuloplasty implant(s).
5. Subject is participating in another clinical investigation including any treatment outside the investigative site's usual standard of care.
6. Subject has anomalous anatomy or medical, surgical, psychiatric or social history or conditions that, in the investigator's opinion, would limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements

Contacts and Locations

Study Contact

Karine Miquel

CONTACT

+32 479 60 01 07

karine.miquel@abbott.com

Leslie Ornelas

CONTACT

+14803067436

leslie.ornelas@abbott.com

Principal Investigator

Vinny Podichetty

STUDY_DIRECTOR

Abbott

Study Locations (Sites)

Duke University Hospital

Durham, North Carolina, 27710

United States

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792

United States

Collaborators and Investigators

Sponsor: Abbott Medical Devices

Vinny Podichetty, STUDY_DIRECTOR, Abbott

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 Date2021-02-01

Study Completion Date2031-03

Study Record Updates

Study Start Date2021-02-01

Study Completion Date2031-03

Terms related to this study

Keywords Provided by Researchers

Mitral Regurgitation
Tricuspid Regurgitation
Valve Surgery
Valve Repair
Annuloplasty Rings
Annuloplasty Bands
Rigid Saddle Ring
Séguin Annuloplasty Ring
Tailor Annuloplasty Ring
Tailor Annuloplasty Band

Additional Relevant MeSH Terms

Mitral Regurgitation
Tricuspid Regurgitation
Valvular Heart Disease