Clinical trial NCT04761120: Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study
Official title: Annuloplasty Rings and Band Post-Market Clinical Follow-Up (ARB-PMCF) Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitral Regurgitation
Tricuspid Regurgitation
Valvular Heart Disease
Keywords: Mitral Regurgitation
Tricuspid Regurgitation
Valve Surgery
Valve Repair
Annuloplasty Rings
Annuloplasty Bands
Rigid Saddle Ring
Séguin Annuloplasty Ring
Tailor Annuloplasty Ring
Tailor Annuloplasty Band
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2021-02-18
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll male and female adult subjects from the general population of cardiac surgery patients who are expected to be implanted with a Rigid Saddle, Séguin or full Tailor Ring for mitral regurgitation (MR) repair, a full Tailor Ring for tricuspid regurgitation (TR) repair or a Tailor Band or partial Tailor Ring for primary TR repair within 90 days.

Brief summary: 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.

Detailed description: The ARB-PMCF Study has a prospective, multicenter, observational, parallel group design in which up to 550 subjects will be followed through five years from implant of an Abbott annuloplasty device, with or without concomitant procedures, in five treatment groups, including primary mitral disease repair (N=200) with the Rigid Saddle Ring, Séguin Ring or full Tailor Ring without cut zone removal; secondary mitral disease repair (N=200) with the Rigid Saddle Ring, Séguin Ring or full Tailor Ring; primary tricuspid disease repair with the full Tailor Ring (N=50); secondary tricuspid disease repair with the full Tailor Ring (N=50); and primary tricuspid disease repair with the Tailor Band or partial Tailor Ring with cut zone removed (N=50). Study enrollment will occur at up to 25 global centers with approximately half or more of all implanted subjects being from European sites. The study will enroll adult subjects expected to be implanted with an Abbott annuloplasty device within 90 days who meet all other eligibility requirements. Participants will complete annual in-clinic or telephone follow-up visits through five years from their annuloplasty implant. Data collected will include adverse events, cardiac medication usage, New York Heart Association functional classification (a measure of the severity of heart failure symptoms) and echocardiographic assessments of regurgitation through the repaired valve.

Eligibility criteria: Inclusion 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Percentage of Participants in Each Treatment Group with Freedom from All-Cause Mortality through 5 Years Post-Implant
timeFrame: 5 years
measure: Percentage of Participants in Each Mitral Treatment Group with Freedom from Reoperation or Transcatheter Reintervention for Mitral Regurgitation through 5 Years Post-Implant
timeFrame: 5 years
measure: Percentage of Participants in Each Tricuspid Treatment Group with at least a 1-Class Reduction in New York Heart Association (NYHA) Functional Classification at 1 Year Post-Implant.
timeFrame: 1 year
Secondary outcomes:
measure: Number of Participants in Each Treatment Group by Grade of Regurgitation in the Valve Undergoing Repair, Pre-Operatively, at Discharge, and at 1, 3 and 5 Years Post-Implant
timeFrame: Pre-Operative Baseline, within 60 days post-implant, and 1, 3 and 5 years post-implant
measure: Number of Participants in Each Treatment Group by NYHA Functional Class, Pre-Operatively and at Discharge, 1, 3 and 5 Years Post-Implant.
timeFrame: Pre-Operative Baseline, within 60 days post-implant, and 1, 3 and 5 years post-implant
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Lyon
country: France
facility: Hopital Cardiovasculaire et Pneumologique Louis Pradel
state: Auvergne-Rhône-Alpes
city: Besançon
country: France
facility: CHU de Besançon - Jean Minjoz
state: Bourgogne-Franche-Comté
city: Passau
country: Germany
facility: Herzchirurgische Abteilung Klinikum Passau
state: Bavaria
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
state: Bayern
city: Dresden
country: Germany
facility: Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden
state: Saxony
city: Jena
country: Germany
facility: Universitätsklinikum Jena
state: Thuringia
city: Bremen
country: Germany
facility: Herzzentrum-Bremen Klinikum Links der Weser
city: Milano
country: Italy
facility: Ospedale San Raffaele - Cardiac
state: Lombardy
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
state: Lombard
city: Torino
country: Italy
facility: Ospedale Umberto I
state: Piemonte
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi
city: Milan
country: Italy
facility: Ospedale Luigi Sacco
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
state: Noord-Brabant
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
state: Pontevedra
Study officials:
affiliation: Abbott
name: Ryan Palmer
role: STUDY_DIRECTOR
References: