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

NCT ID: NCT05174442

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

685 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-14

Study Completion Date

2027-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Occlutech International AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitätsklinikum Erlangen

Erlangen, , Germany

Site Status RECRUITING

Kliniken Maria Hilf GmbH

Mönchengladbach, , Germany

Site Status ACTIVE_NOT_RECRUITING

Klinikum der Universität München

München, , Germany

Site Status RECRUITING

Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi

Adana, Balcalı, Turkey (Türkiye)

Site Status RECRUITING

İnönü Üniversitesi Tıp Fakültesi Hastanesi

Malatya, Battalgazi, Turkey (Türkiye)

Site Status RECRUITING

İzmir Şehir Hastanesi

Izmir, Bayraklı, Turkey (Türkiye)

Site Status RECRUITING

Aydın Adnan Menderes Üniversitesi Hastanesi

Aydin, Efeler, Turkey (Türkiye)

Site Status RECRUITING

Bezmialem Tıp Fakültesi Hastanesi

Istanbul, Fatih, Turkey (Türkiye)

Site Status RECRUITING

Antalya Akdeniz Üniversitesi Hastanesi

Antalya, Konyaaltı, Turkey (Türkiye)

Site Status WITHDRAWN

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

Istanbul, Küçükçekmece, Turkey (Türkiye)

Site Status RECRUITING

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

Istanbul, Küçükçekmece, Turkey (Türkiye)

Site Status RECRUITING

Karaman Eğitim ve Araştırma Hastanesi

Karaman, Merkez, Turkey (Türkiye)

Site Status RECRUITING

Dicle Üniversitesi Tıp Fakültesi Hastanesi

Diyarbakır, Sur, Turkey (Türkiye)

Site Status RECRUITING

Medicana International Ankara Hastanesi

Ankara, Söğütözü, Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Ankara Etlik Şehir Hastanesi

Ankara, Yenimahalle, Turkey (Türkiye)

Site Status RECRUITING

Adana City Training and Research Hospital

Adana, , Turkey (Türkiye)

Site Status RECRUITING

Hacettepe Üniversitesi Hastanesi

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Gazi University Medical Faculty Hospital Adult

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Gazi University Medical Faculty Hospital Pediatric

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Antalya Training and Research Hospital (Adult)

Antalya, , Turkey (Türkiye)

Site Status RECRUITING

Antalya Training and Research Hospital (Pediatric)

Antalya, , Turkey (Türkiye)

Site Status RECRUITING

SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Pamukkale Üniversitesi Klinik Uygulama ve Araştırma Merkezi Hastanesi

Denizli, , Turkey (Türkiye)

Site Status RECRUITING

Dicle Üniversitesi Tıp Fakültesi Sağlık ve Araştırma Hastanesi

Diyarbakır, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Eskişehir Osmangazi University Adult

Eskişehir, , Turkey (Türkiye)

Site Status RECRUITING

Eskişehir Osmangazi University Pediatric

Eskişehir, , Turkey (Türkiye)

Site Status RECRUITING

Isparta Süleyman Demirel Üniversitesi Araştırma ve Uygulama Hastanesi

Isparta, , Turkey (Türkiye)

Site Status RECRUITING

Istanbul Basaksahir Cam and Sakura City Hospital(Adult)

Istanbul, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Istanbul Basaksehir Cam and Sakura City Hospital (Pediatric)

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Istanbul Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Kocaeli University Hospital

Kocaeli, , Turkey (Türkiye)

Site Status RECRUITING

Necmettin Erbakan Üniversitesi Meram Tıp Fakültesi

Konya, , Turkey (Türkiye)

Site Status RECRUITING

Mardin Artuklu Üniversitesi Tıp Fakültesi Hastanesi

Mardin, , Turkey (Türkiye)

Site Status RECRUITING

Mersin University Faculty of Medicine Hospital

Mersin, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

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

Trabzon, , Turkey (Türkiye)

Site Status RECRUITING

Gaziantep Üniversitesi Şahinbey Araştırma ve Uygulama Hastanesi

Gaziantep, Şehitkamil, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Germany Turkey (Türkiye)

Central Contacts

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Gönül Sönmez Utkun

Role: CONTACT

[email protected]
+90 542 826 11 95

Inga-Maria Wefel

Role: CONTACT

[email protected]
+49 171 715 85 88

Facility Contacts

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Mohamed Marwan, MD

Role: primary

[email protected]
0049 0160-49 17 39

Yvonne Burkhardt, SC

Role: backup

[email protected]
0049 0160-49 17 39

Fadli Demir, MD

Role: primary

[email protected]

Role: primary

05324666432

Barış Kılıçaslan, MD

Role: primary

[email protected]
0505 588 81 88

Serkan Fazlı Çelik

Role: primary

[email protected]
5067795119

Ramazan Ozdemır, Prof. Dr.

Role: primary

[email protected]
05324636064

Ahmet Yılmaz, Dr.Öğr.

Role: primary

[email protected]
0090 532 632 91 15

Alper Akın

Role: primary

[email protected]
05436228088

I. Hakan Güllü, MD

Role: primary

[email protected]
0532 052 14 26

İbrahim Halil Kurt, Prof. Dr., MD

Role: primary

[email protected]

Serdar Kula, MD

Role: primary

[email protected]
+90 555 368 49 26

Yaren Tercanlı, SC

Role: backup

[email protected]
+90 537 470 45 94

Alev Kılıçgedik, Prof. Dr., MD

Role: primary

[email protected]

İbrahim Cansaran Tanıdır, Assoc. Prof. Dr., MD

Role: primary

Mustafa Çalışkan, MD, Prof. Dr.

Role: primary

[email protected]

Derya Karpuz, Assoc. Prof. Dr, MD

Role: primary

[email protected]

Osman Başpınar, Prof. Dr

Role: primary

[email protected]
5323455477

Other Identifiers

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Occ2021_03

Identifier Type: -

Identifier Source: org_study_id

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