Clinical trial NCT05174442: ACCESS Registry: A Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory Medical Devices
Official title: A Registry-based, Multicenter, International, Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory Medical Devices:Occlutech Delivery Set (ODS), Occlutech Pistol Pusher (OPP), Occlutech Occlusions-Pusher (OOP), Occlutech Sizing Balloon (OSB) Used During to Implantation Procedures of Cardiac Implant Devices
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Diseases
Lead sponsor: Occlutech International AB
Sponsor class: INDUSTRY
First posted: 2021-12-30
Enrollment: 385
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects who underwent implantation procedure with an Occlutech accessory medical device and cardiac implants can be included. Preconditions depend exclusively on the requirements outlined in the applicable Instruction for Use of the implant and the accessories.

Brief summary: The registry is an international, multicenter, non-randomized, non-invasive study to assess the safety, performance and usability of the Occlutech Accessories "Occlutech Delivery Set (ODS), Occlutech Pistol Pusher (OPP), Occlutech Occlusions-Pusher (OOP) and Occlutech Sizing Balloon (OSB)" used for implantation procedures (catheter-based interventions) of cardiac implants via completing surveys (questionnaires) for the accessory medical devices by the investigators.

Detailed description: The registry is an international, multicenter, non-randomized, non-invasive study to assess the safety, performance and usability of the Occlutech Accessories "Occlutech Delivery Set (ODS), Occlutech Pistol Pusher (OPP), Occlutech Occlusions-Pusher (OOP) and Occlutech Sizing Balloon (OSB)" used for implantation procedures (catheter-based interventions) of cardiac implants via completing surveys (questionnaires) for the accessory medical devices by the investigators.

A survey (questionnaire) of each accessory medical device should be completed by investigator in order to assess safety of the accessory by success of implantation procedure, occurrence of adverse events during implantation procedure or as late term effects resulting from implantation procedure, user harm related to the accessory, procedure, reported device deficiencies related to the accessory. The Surveys (questionnaires) also include questions related to performance, usability and compatibility with devices and other accessories. Subjects should be treated according to instructions-for-use of the implants and accessories and according to clinical routine. The devices must have been used exclusively by physicians who are experienced in cardiac catheterization techniques and who are experienced in using the products in the process of interventional operations.

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria depend exclusively on the requirements outlined in the applicable Instruction for Use for accessory medical devices and cardiac implant devices.

All subjects who underwent implantation procedure with an Occlutech accessory medical device and cardiac implants can be included

Exclusion Criteria:

* Exclusion Criteria depend exclusively on the requirements outlined in the applicable Instruction for Use and if applicable in the corresponding protocol of the investigation on the Occlutech implant devices.

Primary outcomes:
measure: Occurence of safety events
timeFrame: 6 months
Secondary outcomes:
measure: Performance, usability:
timeFrame: 6 months
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Uniklinik Erlangen
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH
city: Adana
country: Turkey
facility: Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi
state: Balcalı
city: Malatya
country: Turkey
facility: İnönü Üniversitesi Tıp Fakültesi Hastanesi
state: Battalgazi
city: Ankara
country: Turkey
facility: Sağlık Bilimleri Üniversitesi Dışkapı Yıldırım Beyazıt Eğitim ve Araştırma Hastanesi
state: Dışkapı
city: Aydın
country: Turkey
facility: Aydın Adnan Menderes Üniversitesi Hastanesi
state: Efeler
city: Istanbul
country: Turkey
facility: Bezmialem Tıp Fakültesi Hastanesi
state: Fatih
city: İzmir
country: Turkey
facility: İzmir Sağlik Bilimleri Üniversitesi Tepecik Eğitim Ve Araştirma Hastanesi
state: Konak
city: Diyarbakır
country: Turkey
facility: Dicle Üniversitesi Tıp Fakültesi Hastanesi
state: Sur
city: Adana
country: Turkey
facility: Adana City Training and Research Hospital
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty Hospital Adult
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty Hospital Pediatric
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital (Adult)
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital (Pediatric)
city: Eskişehir
country: Turkey
facility: Eskişehir Osmangazi University Adult
city: Eskişehir
country: Turkey
facility: Eskişehir Osmangazi University Pediatric
city: Istanbul
country: Turkey
facility: Istanbul Basaksahir Cam and Sakura City Hospital(Adult)
city: Istanbul
country: Turkey
facility: Istanbul Basaksehir Cam and Sakura City Hospital (Pediatric)
city: Istanbul
country: Turkey
facility: Istanbul Prof. Dr. Suleyman Yalcin City Hospital
city: Kocaeli
country: Turkey
facility: Kocaeli University Hospital
city: Mersin
country: Turkey
facility: Mersin University Faculty of Medicine Hospital
city: Gaziantep
country: Turkey
facility: Gaziantep Üniversitesi Şahinbey Araştırma ve Uygulama Hastanesi
state: Şehitkamil
Study officials:
References: