ACCESS Registry: A Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory Medical Devices

NCT05174442 | Recruiting

• 1 other identifier: Occ2021_03
• Study Type: observational
• Target: 685
• Locations: 2 countries
• Sites: 36

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.

Conditions

Heart Diseases

Outcome Measures

Primary Outcomes (1)

• Occurence of safety events

  The primary safety endpoint is defined as the rate of incidences of (peri-) procedural adverse events / rate of (serious) adverse device effects ((S)ADEs) during implantation or as late effects of implantation procedure. A serious adverse device effect (SADE) is defined as an event that is clearly caused by the device such as: * device dislocation (during the procedures with OPP, OOP,ODS) * embolization related with procedure and accessories * Late effect of implantation procedure: damage to the vessels and heart caused by the accessories * any circumstances that require device removal related with procedure or accessories used during the implantation * Signs of thrombosis

  6 months

Secondary Outcomes (1)

• Performance, usability:

  6 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Occlutech International AB: lead

Study Sites (36)

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

RECRUITING

Kliniken Maria Hilf GmbH

Mönchengladbach, Germany

ACTIVE NOT RECRUITING

Klinikum der Universität München

München, 81377, Germany

RECRUITING

Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi

Adana, Balcalı, 01330, Turkey (Türkiye)

RECRUITING

İnönü Üniversitesi Tıp Fakültesi Hastanesi

Malatya, Battalgazi, 44280, Turkey (Türkiye)

RECRUITING

İzmir Şehir Hastanesi

Izmir, Bayraklı, 35540, Turkey (Türkiye)

RECRUITING

Aydın Adnan Menderes Üniversitesi Hastanesi

Aydin, Efeler, 09100, Turkey (Türkiye)

RECRUITING

Bezmialem Tıp Fakültesi Hastanesi

Istanbul, Fatih, 34093, Turkey (Türkiye)

RECRUITING

Antalya Akdeniz Üniversitesi Hastanesi

Antalya, Konyaaltı, 07070, Turkey (Türkiye)

WITHDRAWN

İstanbul Mehmet Akif Ersoy Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi

Istanbul, Küçükçekmece, 34303, Turkey (Türkiye)

RECRUITING

İstanbul Mehmet Akif Ersoy Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi

Istanbul, Küçükçekmece, 34303, Turkey (Türkiye)

RECRUITING

Karaman Eğitim ve Araştırma Hastanesi

Karaman, Merkez, 70200, Turkey (Türkiye)

RECRUITING

Dicle Üniversitesi Tıp Fakültesi Hastanesi

Diyarbakır, Sur, 21280, Turkey (Türkiye)

RECRUITING

Medicana International Ankara Hastanesi

Ankara, Söğütözü, 06520, Turkey (Türkiye)

NOT YET RECRUITING

Ankara Etlik Şehir Hastanesi

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

RECRUITING

Adana City Training and Research Hospital

Adana, Turkey (Türkiye)

RECRUITING

Hacettepe Üniversitesi Hastanesi

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Gazi University Medical Faculty Hospital Adult

Ankara, Turkey (Türkiye)

RECRUITING

Gazi University Medical Faculty Hospital Pediatric

Ankara, Turkey (Türkiye)

RECRUITING

Antalya Training and Research Hospital (Adult)

Antalya, Turkey (Türkiye)

RECRUITING

Antalya Training and Research Hospital (Pediatric)

Antalya, Turkey (Türkiye)

RECRUITING

SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, 16310, Turkey (Türkiye)

NOT YET RECRUITING

Pamukkale Üniversitesi Klinik Uygulama ve Araştırma Merkezi Hastanesi

Denizli, 20160, Turkey (Türkiye)

RECRUITING

Dicle Üniversitesi Tıp Fakültesi Sağlık ve Araştırma Hastanesi

Diyarbakır, 21100, Turkey (Türkiye)

NOT YET RECRUITING

Eskişehir Osmangazi University Adult

Eskişehir, Turkey (Türkiye)

RECRUITING

Eskişehir Osmangazi University Pediatric

Eskişehir, Turkey (Türkiye)

RECRUITING

Isparta Süleyman Demirel Üniversitesi Araştırma ve Uygulama Hastanesi

Isparta, 32260, Turkey (Türkiye)

RECRUITING

Istanbul Basaksahir Cam and Sakura City Hospital(Adult)

Istanbul, Turkey (Türkiye)

NOT YET RECRUITING

Istanbul Basaksehir Cam and Sakura City Hospital (Pediatric)

Istanbul, Turkey (Türkiye)

RECRUITING

Istanbul Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, Turkey (Türkiye)

NOT YET RECRUITING

Kocaeli University Hospital

Kocaeli, Turkey (Türkiye)

RECRUITING

Necmettin Erbakan Üniversitesi Meram Tıp Fakültesi

Konya, 142080, Turkey (Türkiye)

RECRUITING

Mardin Artuklu Üniversitesi Tıp Fakültesi Hastanesi

Mardin, 47200, Turkey (Türkiye)

RECRUITING

Mersin University Faculty of Medicine Hospital

Mersin, Turkey (Türkiye)

NOT YET RECRUITING

S.B.Ü Ahi Evren Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi

Trabzon, 61040, Turkey (Türkiye)

RECRUITING

Gaziantep Üniversitesi Şahinbey Araştırma ve Uygulama Hastanesi

Gaziantep, Şehitkamil, 27310, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Central Study Contacts

Gönül Sönmez Utkun

CONTACT

+90 542 826 11 95; gonul.sonmezutkun@occlutech.com

Inga-Maria Wefel

CONTACT

+49 171 715 85 88; dl_occlutech_clinical_team_eu-ist@occlutech.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: December 30, 2021
• Study Start: October 14, 2021
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-07

Locations

TU (33); DE (3)