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Heart DiseasesNCT05174442

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

An observational study of Heart Diseases, run by Occlutech International AB at 36 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Heart Diseases
How many people
685 participants
Where
36 sitesin 2 countries
Study dates
14 Oct 2021to 1 Jan 2027
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

36 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

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

36 sites in 2 countries

Turkey (Türkiye)33 sites, 32 recruiting

  • Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi

    Adana, Balcalı, 01330

    Fadli Demir, MD, fadlidemir@yahoo.com

    Fadli Demir

    Recruiting

  • Adana City Training and Research Hospital

    Adana

    İbrahim Halil Kurt, Prof. Dr., MD, ibrahimhalilkurt@gmail.com

    İbrahim Halil Kurt, Prof. Dr., MD

    Recruiting

  • Medicana International Ankara Hastanesi

    Ankara, Söğütözü, 06520

    Engin Bozkurt, Prof.

    Not yet recruiting

  • Ankara Etlik Şehir Hastanesi

    Ankara, Yenimahalle, 06170

    I. Hakan Güllü, MD, 0532 052 14 26, drgullu@gmail.com

    I. Hakan Güllü, MD

    Recruiting

  • Hacettepe Üniversitesi Hastanesi

    Ankara, 06230

    Ergün Barış Kaya, Prof.

    Recruiting

  • Gazi University Medical Faculty Hospital Adult

    Ankara

    Salih Topal, MD

    Recruiting

  • Gazi University Medical Faculty Hospital Pediatric

    Ankara

    Serdar Kula, MD, +90 555 368 49 26, kula@gazi.edu.tr

    Yaren Tercanlı, SC, +90 537 470 45 94, yaren.tercanli@medex-smo.com

    Recruiting

  • Antalya Akdeniz Üniversitesi Hastanesi

    Antalya, Konyaaltı, 07070

    Withdrawn

  • Antalya Training and Research Hospital (Adult)

    Antalya

    Şakir Arslan, Prof.

    Recruiting

  • Antalya Training and Research Hospital (Pediatric)

    Antalya

    Abdullah Kocabaş, Prof.

    Recruiting

  • Aydın Adnan Menderes Üniversitesi Hastanesi

    Aydin, Efeler, 09100

    Serkan Fazlı Çelik, 5067795119, docser2003@yahoo.com

    Serkan Fazlı Çelik

    Recruiting

  • SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

    Bursa, 16310

    Hasan Arı, Prof.

    Not yet recruiting

  • Pamukkale Üniversitesi Klinik Uygulama ve Araştırma Merkezi Hastanesi

    Denizli, 20160

    Doğu Akif Kılıç, Prof.

    Recruiting

  • Dicle Üniversitesi Tıp Fakültesi Hastanesi

    Diyarbakır, Sur, 21280

    Alper Akın, 05436228088, alperakin1@hotmail.com

    Alper Akın

    Recruiting

  • Dicle Üniversitesi Tıp Fakültesi Sağlık ve Araştırma Hastanesi

    Diyarbakır, 21100

    Mehmet Ata Akil, Prof.

    Not yet recruiting

  • Eskişehir Osmangazi University Adult

    Eskişehir

    Yüksel Çavuşoğlu, MD

    Recruiting

  • Eskişehir Osmangazi University Pediatric

    Eskişehir

    Birsen Uçar, MD

    Recruiting

  • Gaziantep Üniversitesi Şahinbey Araştırma ve Uygulama Hastanesi

    Gaziantep, Şehitkamil, 27310

    Osman Başpınar, Prof. Dr, 5323455477, osmanbaspinar@hotmail.com

    Osman Başpınar

    Recruiting

  • Isparta Süleyman Demirel Üniversitesi Araştırma ve Uygulama Hastanesi

    Isparta, 32260

    Fathi Akif Aksoy, Prof.

    Recruiting

  • Bezmialem Tıp Fakültesi Hastanesi

    Istanbul, Fatih, 34093

    Ramazan Ozdemır, Prof. Dr., 05324636064, rozdemir@bezmialem.edu.tr

    Ramazan Ozdemır, Prof. Dr.

    Recruiting

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

    Istanbul, Küçükçekmece, 34303

    Mehmet Ertürk, Prof.

    Recruiting

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

    Istanbul, Küçükçekmece, 34303

    Alper Güzeltaş, Prof.

    Recruiting

  • Istanbul Basaksahir Cam and Sakura City Hospital(Adult)

    Istanbul

    Alev Kılıçgedik, Prof. Dr., MD, akilicgedik@yahoo.com

    Alev Kılıçgedik, Prof. Dr., MD

    Not yet recruiting

  • Istanbul Basaksehir Cam and Sakura City Hospital (Pediatric)

    Istanbul

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

    Recruiting

  • Istanbul Prof. Dr. Suleyman Yalcin City Hospital

    Istanbul

    Mustafa Çalışkan, MD, Prof. Dr., caliskandr@gmail.com

    Mustafa Çalışkan, MD, Prof. Dr.

    Not yet recruiting

  • İzmir Şehir Hastanesi

    Izmir, Bayraklı, 35540

    Barış Kılıçaslan, MD, 0505 588 81 88, kiliaslanbaris@yahoo.com

    Barış Kılıçaslan, MD

    Recruiting

  • Karaman Eğitim ve Araştırma Hastanesi

    Karaman, Merkez, 70200

    Ahmet Yılmaz, Dr.Öğr., 0090 532 632 91 15, Dr.ahmetyilmaz@gmail.com

    Ahmet Yılmaz

    Recruiting

  • Kocaeli University Hospital

    Kocaeli

    Teoman Kılıç, Prof.

    Recruiting

  • Necmettin Erbakan Üniversitesi Meram Tıp Fakültesi

    Konya, 142080

    Mehmet Akif Düzenli, Prof.

    Recruiting

  • İnönü Üniversitesi Tıp Fakültesi Hastanesi

    Malatya, Battalgazi, 44280

    05324666432

    Özlem Elkiran, Prof.

    Recruiting

  • Mardin Artuklu Üniversitesi Tıp Fakültesi Hastanesi

    Mardin, 47200

    Mehmet Zülkif Karahan, Prof.

    Recruiting

  • Mersin University Faculty of Medicine Hospital

    Mersin

    Derya Karpuz, Assoc. Prof. Dr, MD, drderyakarpuz@gmail.com

    Derya Karpuz, Assoc. Prof. Dr., MD

    Not yet recruiting

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

    Trabzon, 61040

    Ali Rıza Akyüz, Prof.

    Recruiting

Other trials in Turkey (Türkiye)

Germany3 sites, 2 recruiting

  • Universitätsklinikum Erlangen

    Erlangen, 91054

    Mohamed Marwan, MD, 0049 0160-49 17 39, mohamed.morwan@uk-erlangen.de

    Yvonne Burkhardt, SC, 0049 0160-49 17 39, yvonne.burkhardt@uk-erlangen.de

    Recruiting

  • Kliniken Maria Hilf GmbH

    Mönchengladbach

    Active, not recruiting

  • Klinikum der Universität München

    München, 81377

    Nikolaus Haas, Prof. Dr. med.

    Recruiting

Other trials in Germany

About this study

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

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.

Read the 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.

Conditions
Heart Diseases
Medical subject headings
Heart Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Secondary outcomes (1)

  1. Performance, usability:

    will be assessed in terms of mechanical performance, procedural data by completing the survey (questionnaire) for each accessory with grading. Compatibility of ODS, OPP, OOP with cardiac implant devices or/and other accessory medical devices.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2021
  2. Study start14 Oct 2021
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
685 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05174442
Sponsor's protocol ID
Occ2021_03
Status last verified
Jul 2025
First submitted
13 Dec 2021
Last updated
4 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Diseases, run by Occlutech International AB at 36 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in Turkey (Türkiye), Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gönül Sönmez Utkun (+90 542 826 11 95, gonul.sonmezutkun@occlutech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurence of safety events (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05174442.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.

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