Clinical trial NCT06590467: Abbott Structural Heart Device Registry
Official title: Abbott Structural Heart Device Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Diseases
ASD - Atrial Septal Defect
VSD - Muscular Ventricular Septal Defect
PFO - Patent Foramen Ovale
PIVSD - Post Infarct Muscular Ventricular Septal Defect
Valvular Heart Disease
Keywords: Amplatzer
Amplatzer Septal Occluder
Amplatzer Multi-fenestrated (Cribriform) Occluder
Amplatzer Duct Occluder
Amplatzer Piccolo Occluder
Amplatzer Muscular VSD Occluder
Amplatzer Post-Infarct VSD Occluder
Amplatzer Talisman
Amplatzer TorqVue Delivery System
Amplatzer Sizing Balloon
Amplatzer Guidewire
Amplatzer Occluder devices
Surgical Valves
Epic Plus Aortic Valve
Epic Plus Mitral Valve
Epic Plus Supra Aortic Valve
Epic Max Aortic Valve
Bioprosthetic heart valve
Surgical tissue heart valve
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 2500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This Registry is open to enroll subjects of all genders and ages from the general population who undergo a procedure that use at least one Abbott SH device included in this Registry (including unsuccessful implants). Subjects must meet all eligibility criteria and provide written informed consent prior to sites conducting any investigation-specific procedures not considered standard of care.

Patients will be screened for eligibility and willingness to participate prior to the procedure or, if enrolled retrospectively, within the timeframe specified in the device-specific appendices of the protocol (Amplatzer cohort: consent within 7days of procedure // Cardiac Surgery cohort: consent within 6 months (183 days) of the implant procedure)

Brief summary: The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting. The Registry primarily involves gathering data from routine hospital practices and standard-of-care (SOC) procedures administered to patients. All devices used in these procedures must be commercially available to the participating site. A list of specific devices covered by the Registry are available upon request from the Sponsor. Data generated by the Registry will be used to meet regulatory requirements, such as the European Union Medical Device Regulations 2017/745, that require active post-market clinical follow-up (PMCF) for all commercially available devices.

Detailed description: The Abbott SH Device Registry is designed to confirm the safety and performance of commercially available Abbott SH devices as they are used in routine hospital practice or SOC procedures. Patients will be screened for eligibility and willingness to participate prior to the procedure or, if enrolled retrospectively, within the following timeframes:

* Amplatzer portion: within 7 days post-procedure
* Cardiac Surgery portion: within 6 months post-procedure.

All patients who provide informed consent and undergo an implant attempt with an applicable Abbott SH device are eligible to participate in the Registry. The Registry anticipates that approximately 500 subjects per year will be enrolled. The projected enrollment period is at least 5 years.

The Registry will be conducted at approximately 25 sites worldwide. Additional sites may be approached for participation in the Registry as needed.

Follow-up visits should align with the site's routine SOC visits for the associated procedure. Data collection will occur post-screening and consent and at post-procedure SOC follow-up visit(s). Where applicable, follow-up visits may occur over the telephone, virtually, or in-office, following SOC practice.

The follow-up duration will depend on the Abbott device(s) used during the procedure. Certain devices will utilize data collection at discharge (or 7 days post procedure, whichever comes first), short-term (1 - 3 months as applicable), a mid-term (6 months), and long-term follow-up (12 months) visits to support clinical safety and performance data requirements. Alternatively, some devices will have follow-up visits extending up to 10 years to monitor subjects throughout the devices' lifetime.

A surgical valve-specific "Line Extension Sub-Study" is included in the protocol to collect data at European sites with the intention of applying for approval in the US for 2 specific surgical aortic valve sizes (Epic Max 27mm, and the Epic Plus Supra 29mm).

Eligibility criteria: Inclusion Criteria:

1. Subject is expected to undergo an implant attempt using one or more Abbott Structural Heart devices covered in this Registry or has previously undergone an implant attempt within the timeframes specified in the device-specific appendices.
2. Subject is willing and able to comply with the site's standard of care follow-up schedule.
3. Subject is willing to provide appropriate informed consent for Registry participation. For deceased subjects enrolled retrospectively, local regulations and EC/IRB recommendations regarding consent and the protection of personal data must be followed.

Exclusion Criteria:

1. Subject is participating in another clinical study that would affect the results of this Registry.

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: 7 days
measure: Primary Effectiveness Endpoint
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHRU Hopital de Pontchaillou
state: Brittan
city: Le Plessis-Robinson
country: France
facility: Centre Médico Chirurgical Marie Lannelongue
city: Pessac
country: France
facility: Hopital Haut Leveque
city: Munchen
country: Germany
facility: Deutsches Herzzentrum München des Freistaates Bayern
state: Bavaria
city: Braunschweig
country: Germany
facility: Städt. Klinikum Braunschweig gGmbH
state: L Saxon
city: Bad Rothenfelde
country: Germany
facility: Schüchtermann-Schiller´sche Kliniken GmbH & Co. KG
city: Berlin
country: Germany
facility: Deutsches Herzzentrum der Charité
city: Jena
country: Germany
facility: Universitatsklinikum Jena
city: San Donato Milanese
country: Italy
facility: Policlinico San Donato
state: Lombardy
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
state: Tuscany
city: Madrid
country: Spain
facility: Hospital Universitario de la Paz - Pediatrico
city: Sevilla
country: Spain
facility: Hospital Virgen de Rocio
city: London
country: United Kingdom
facility: Royal Brompton Hospital
state: UK
city: London
country: United Kingdom
facility: St. Thomas Hospital
Study officials:
affiliation: Abbott
name: Ryan Palmer
role: STUDY_DIRECTOR
References: