Actively Recruiting
Post Market Follow-up Study to Monitor Safety, Performance, and Usability of Occlutech Accessory Devices Used in Cardiac Implant Procedures
Led by Occlutech International AB · Updated on 2025-12-04
685
Participants Needed
36
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety, performance, and usability of several Occlutech accessory medical devices used in heart disease treatment. These devices include the Occlutech Delivery Set (ODS), Occlutech Pistol Pusher (OPP), Occlutech Occlusions-Pusher (OOP), and Occlutech Sizing Balloon (OSB). The study is international, multicenter, non-randomized, and non-invasive, focusing on catheter-based implantation procedures for cardiac implants. The study involves physicians experienced in cardiac catheterization using these accessories during implantation procedures. Investigators complete detailed surveys to assess each device's safety, including success of implantation, adverse events during or after the procedure, user harm, and any device deficiencies. The surveys also evaluate the performance, usability, and compatibility of these accessories with other devices. Subjects receive treatment following standard clinical routines and specific instructions for use. Participants who have undergone implantation with an Occlutech accessory and cardiac implant are included. Researchers monitor safety events and assess device performance and usability over a 6-month period. Data is collected via investigator questionnaires, focusing on implantation outcomes and any related complications. The total participation duration varies depending on individual follow-up but includes at least 6 months of monitoring for safety and performance.
CONDITIONS
Brief Title
ACCESS Registry: A Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory Medical Devices
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet all requirements outlined in the instructions for use for the accessory medical devices and cardiac implants
- Have undergone an implantation procedure using an Occlutech accessory medical device and cardiac implant
You will not qualify if you...
- Do not meet the requirements outlined in the instructions for use or the corresponding protocol of the Occlutech implant devices
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants who undergo routine care with Occlutech accessory devices during cardiac implant procedures are observed to assess safety, performance, and usability through surveys completed by investigators.
Visits aligned with routine clinical follow-up over 6 months
Trial Site Locations
Total: 36 locations
1
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Actively Recruiting
2
Kliniken Maria Hilf GmbH
Mönchengladbach, Germany
Active, Not Recruiting
3
Klinikum der Universität München
München, Germany, 81377
Actively Recruiting
4
Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi
Adana, Balcalı, Turkey (Türkiye), 01330
Actively Recruiting
5
İnönü Üniversitesi Tıp Fakültesi Hastanesi
Malatya, Battalgazi, Turkey (Türkiye), 44280
Actively Recruiting
6
İzmir Şehir Hastanesi
Izmir, Bayraklı, Turkey (Türkiye), 35540
Actively Recruiting
7
Aydın Adnan Menderes Üniversitesi Hastanesi
Aydin, Efeler, Turkey (Türkiye), 09100
Actively Recruiting
8
Bezmialem Tıp Fakültesi Hastanesi
Istanbul, Fatih, Turkey (Türkiye), 34093
Actively Recruiting
9
Antalya Akdeniz Üniversitesi Hastanesi
Antalya, Konyaaltı, Turkey (Türkiye), 07070
Withdrawn
10
İstanbul Mehmet Akif Ersoy Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi
Istanbul, Küçükçekmece, Turkey (Türkiye), 34303
Actively Recruiting
11
İstanbul Mehmet Akif Ersoy Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi
Istanbul, Küçükçekmece, Turkey (Türkiye), 34303
Actively Recruiting
12
Karaman Eğitim ve Araştırma Hastanesi
Karaman, Merkez, Turkey (Türkiye), 70200
Actively Recruiting
13
Dicle Üniversitesi Tıp Fakültesi Hastanesi
Diyarbakır, Sur, Turkey (Türkiye), 21280
Actively Recruiting
14
Medicana International Ankara Hastanesi
Ankara, Söğütözü, Turkey (Türkiye), 06520
Not Yet Recruiting
15
Ankara Etlik Şehir Hastanesi
Ankara, Yenimahalle, Turkey (Türkiye), 06170
Actively Recruiting
16
Adana City Training and Research Hospital
Adana, Turkey (Türkiye)
Actively Recruiting
17
Hacettepe Üniversitesi Hastanesi
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
18
Gazi University Medical Faculty Hospital Adult
Ankara, Turkey (Türkiye)
Actively Recruiting
19
Gazi University Medical Faculty Hospital Pediatric
Ankara, Turkey (Türkiye)
Actively Recruiting
20
Antalya Training and Research Hospital (Adult)
Antalya, Turkey (Türkiye)
Actively Recruiting
21
Antalya Training and Research Hospital (Pediatric)
Antalya, Turkey (Türkiye)
Actively Recruiting
22
SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Bursa, Turkey (Türkiye), 16310
Not Yet Recruiting
23
Pamukkale Üniversitesi Klinik Uygulama ve Araştırma Merkezi Hastanesi
Denizli, Turkey (Türkiye), 20160
Actively Recruiting
24
Dicle Üniversitesi Tıp Fakültesi Sağlık ve Araştırma Hastanesi
Diyarbakır, Turkey (Türkiye), 21100
Not Yet Recruiting
25
Eskişehir Osmangazi University Adult
Eskişehir, Turkey (Türkiye)
Actively Recruiting
26
Eskişehir Osmangazi University Pediatric
Eskişehir, Turkey (Türkiye)
Actively Recruiting
27
Isparta Süleyman Demirel Üniversitesi Araştırma ve Uygulama Hastanesi
Isparta, Turkey (Türkiye), 32260
Actively Recruiting
28
Istanbul Basaksahir Cam and Sakura City Hospital(Adult)
Istanbul, Turkey (Türkiye)
Not Yet Recruiting
29
Istanbul Basaksehir Cam and Sakura City Hospital (Pediatric)
Istanbul, Turkey (Türkiye)
Actively Recruiting
30
Istanbul Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, Turkey (Türkiye)
Not Yet Recruiting
31
Kocaeli University Hospital
Kocaeli, Turkey (Türkiye)
Actively Recruiting
32
Necmettin Erbakan Üniversitesi Meram Tıp Fakültesi
Konya, Turkey (Türkiye), 142080
Actively Recruiting
33
Mardin Artuklu Üniversitesi Tıp Fakültesi Hastanesi
Mardin, Turkey (Türkiye), 47200
Actively Recruiting
34
Mersin University Faculty of Medicine Hospital
Mersin, Turkey (Türkiye)
Not Yet Recruiting
35
S.B.Ü Ahi Evren Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi
Trabzon, Turkey (Türkiye), 61040
Actively Recruiting
36
Gaziantep Üniversitesi Şahinbey Araştırma ve Uygulama Hastanesi
Gaziantep, Şehitkamil, Turkey (Türkiye), 27310
Actively Recruiting
Research Team
G
Gönül Sönmez Utkun
I
Inga-Maria Wefel
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here