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

Mitral Regurgitation Clinical Trial

— ARB-PMCF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04761120
• Other study ID #: ABT-CIP-10368
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: March 2031

Study information

• Verified date: September 2023
• Source: Abbott Medical Devices
• Contact: Karine Miquel
• Phone: +32 479 60 01 07
• Email: karine.miquel[@]abbott.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: March 2031
• Est. primary completion date: November 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Mitral Regurgitation
• Mitral Valve Insufficiency
• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency
• Valvular Heart Disease

Intervention

Device:
• Abbott SJM Rigid Saddle Ring
The Abbott SJM Rigid Saddle Ring is a rigid, polyester-velour-covered, titanium alloy mitral annuloplasty ring with a saddle shape intended to mimic the shape of a healthy mitral annulus during systole.
• Abbott SJM Séguin Ring
The Abbott SJM Séguin Ring is a semi-rigid, polyester-velour-covered, polyethylene mitral annuloplasty ring that varies in thickness and flexibility over its circumference, with the posterior portion of the ring having greater flexibility than the anterior portion.
• Abbott SJM Tailor Ring
The Abbott SJM Tailor Ring is a flexible, polyester-velour-covered, silicone annuloplasty ring indicated for use in surgical repair of the mitral or tricuspid valve. The Tailor Ring can be implanted as a full annuloplasty ring, or the surgeon can remove the ring's cut zone with a scalpel and use the partial Tailor Ring as a posterior annuloplasty band.
• Abbott SJM Tailor Band
The Abbott SJM Tailor Band is a flexible, polyester-velour-covered, silicone band for posterior annuloplasty indicated for use in surgical repair of mitral or tricuspid valve. The Tailor Band is identical to the Tailor Ring with the cut zone removed, save that the polyester covering is sewn closed at the ends of the band during manufacturing.

Locations

Country	Name	City	State
Estonia	Tartu University Hospital	Tartu
France	CHU de Besançon - Jean Minjoz	Besançon	Bourgogne-Franche-Comté
France	Hopital Cardiovasculaire et Pneumologique Louis Pradel	Lyon	Auvergne-Rhône-Alpes
Germany	Herzzentrum-Bremen Klinikum Links der Weser	Bremen
Germany	Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden	Dresden	Saxony
Germany	Universitätsklinikum Jena	Jena	Thuringia
Germany	Herzchirurgische Abteilung Klinikum Passau	Passau	Bavaria
Germany	Universitätsklinikum Würzburg	Würzburg	Bayern
Italy	Policlinico S.Orsola-Malpighi	Bologna
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan	Lombard
Italy	Ospedale Luigi Sacco	Milan
Italy	Ospedale San Raffaele - Cardiac	Milano	Lombardy
Italy	Ospedale Umberto I	Torino	Piemonte
Netherlands	Catharina Ziekenhuis	Eindhoven	Noord-Brabant
Spain	Hospital Alvaro Cunqueiro	Vigo	Pontevedra
United States	Duke University Hospital	Durham	North Carolina
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Estonia,  France,  Germany,  Italy,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants in Each Treatment Group with Freedom from All-Cause Mortality through 5 Years Post-Implant	Percentage of participants in each study treatment group (Groups 1 through 5) who are free of death from any cause through 5 years after their Abbott annuloplasty device implant, estimated from time-to-event data using the Kaplan-Meier estimator. This outcome will be reported for each treatment group separately.	5 years
Primary	Percentage of Participants in Each Mitral Treatment Group with Freedom from Reoperation or Transcatheter Reintervention for Mitral Regurgitation through 5 Years Post-Implant	Percentage of participants in each mitral treatment group (Groups 1 and 2) who are free from reoperation or transcatheter intervention for mitral regurgitation through 5 years after their Abbott annuloplasty implant, estimated from time-to-event data using the Kaplan-Meier estimator. This outcome will be reported separately for Group 1 and Group 2.	5 years
Primary	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.	This outcome will be reported for each tricuspid repair group (Groups 3 through 5) separately. NYHA functional classification is a widely used indicator of the severity of heart failure symptoms with four classes: Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath).; Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, or dyspnea.; Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.; Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.	1 year
Secondary	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	This outcome will be reported for each treatment group separately at each timepoint. Regurgitation occurs when a heart valve does not fully seal, allowing backflow of blood through the closed valve. Mitral and tricuspid valve regurgitation in this study will be graded as none/trivial, mild, moderate or severe by echocardiographic assessment. Moderate or severe regurgitation can cause symptoms of heart failure, such as fatigue, shortness of breath and exercise intolerance.	Pre-Operative Baseline, within 60 days post-implant, and 1, 3 and 5 years post-implant
Secondary	Number of Participants in Each Treatment Group by NYHA Functional Class, Pre-Operatively and at Discharge, 1, 3 and 5 Years Post-Implant.	This outcome will be reported for each treatment group separately at each timepoint. NYHA functional classification is a widely used indicator of the severity of heart failure symptoms with four classes: Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath).; Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, or dyspnea.; Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.; Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.	Pre-Operative Baseline, within 60 days post-implant, and 1, 3 and 5 years post-implant