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

August 11, 2023 updated by: Occlutech International AB

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

385

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Erlangen, Germany
        • Recruiting
        • Uniklinik Erlangen
        • Principal Investigator:
          • Mohamed Marwan, Prof.
      • Mönchengladbach, Germany
        • Recruiting
        • Kliniken Maria Hilf GmbH
        • Principal Investigator:
          • Gregor Nothofer, Dr. med.
  • Turkey
      • Adana, Turkey
        • Not yet recruiting
        • Adana City Training and Research Hospital
        • Contact:
        • Principal Investigator:
          • İbrahim Halil Kurt, Prof. Dr., MD
      • Ankara, Turkey
        • Recruiting
        • Gazi University Medical Faculty Hospital Adult
        • Principal Investigator:
          • Salih Topal, MD
      • Ankara, Turkey
        • Recruiting
        • Gazi University Medical Faculty Hospital Pediatric
        • Principal Investigator:
          • Serdar Kula, MD
      • Antalya, Turkey
        • Recruiting
        • Antalya Training and Research Hospital (Adult)
        • Principal Investigator:
          • Şakir Arslan, Prof.
      • Antalya, Turkey
        • Recruiting
        • Antalya Training and Research Hospital (Pediatric)
        • Principal Investigator:
          • Abdullah Kocabaş, Prof.
      • Eskişehir, Turkey
        • Recruiting
        • Eskişehir Osmangazi University Adult
        • Principal Investigator:
          • Yuksel Cavusoglu, MD
      • Eskişehir, Turkey
        • Recruiting
        • Eskişehir Osmangazi University Pediatric
        • Principal Investigator:
          • Birsen Uçar, MD
      • Istanbul, Turkey
        • Not yet recruiting
        • Istanbul Basaksahir Cam and Sakura City Hospital(Adult)
        • Contact:
        • Principal Investigator:
          • Alev Kılıçgedik, Prof. Dr., MD
      • Istanbul, Turkey
        • Not yet recruiting
        • Istanbul Basaksehir Cam and Sakura City Hospital (Pediatric)
        • Contact:
          • İbrahim Cansaran Tanıdır, Assoc. Prof. Dr., MD
        • Principal Investigator:
          • İbrahim Cansaran Tanıdır, Assoc. Prof. Dr., MD
      • Istanbul, Turkey
        • Not yet recruiting
        • Istanbul Prof. Dr. Suleyman Yalcin City Hospital
        • Contact:
        • Principal Investigator:
          • Mustafa Çalışkan, MD, Prof. Dr.
      • Kocaeli, Turkey
        • Not yet recruiting
        • Kocaeli University Hospital
        • Principal Investigator:
          • Teoman Kılıç, Prof.
      • Mersin, Turkey
        • Not yet recruiting
        • Mersin University Faculty of Medicine Hospital
        • Contact:
        • Principal Investigator:
          • Derya Karpuz, Assoc. Prof. Dr., MD
    • Balcalı
      • Adana, Balcalı, Turkey, 01330
        • Recruiting
        • Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi
        • Principal Investigator:
          • Fadli Demir
        • Sub-Investigator:
          • Nazan Özbarlas
        • Contact:
    • Battalgazi
      • Malatya, Battalgazi, Turkey, 44280
        • Recruiting
        • İnönü Üniversitesi Tıp Fakültesi Hastanesi
        • Contact:
        • Principal Investigator:
          • Cemşit Karakurt
    • Dışkapı
      • Ankara, Dışkapı, Turkey
        • Recruiting
        • Sağlık Bilimleri Üniversitesi Dışkapı Yıldırım Beyazıt Eğitim ve Araştırma Hastanesi
        • Contact:
        • Principal Investigator:
          • I. Hakan Güllü, MD
    • Efeler
      • Aydın, Efeler, Turkey, 09100
        • Recruiting
        • Aydın Adnan Menderes Universitesi Hastanesi
        • Contact:
        • Principal Investigator:
          • Serkan Fazlı Çelik
    • Fatih
      • Istanbul, Fatih, Turkey, 34093
        • Recruiting
        • Bezmialem Tıp Fakültesi Hastanesi
        • Contact:
        • Principal Investigator:
          • Ramazan Ozdemır, Prof. Dr.
    • Konak
      • İzmir, Konak, Turkey
        • Recruiting
        • İzmir Sağlik Bilimleri Üniversitesi Tepecik Eğitim Ve Araştirma Hastanesi
        • Contact:
        • Principal Investigator:
          • Barış Kılıçaslan, MD
    • Sur
      • Diyarbakır, Sur, Turkey, 21280
        • Recruiting
        • Dicle Üniversitesi Tıp Fakültesi Hastanesi
        • Contact:
        • Principal Investigator:
          • Alper Akın
    • Şehitkamil
      • Gaziantep, Şehitkamil, Turkey, 27310
        • Recruiting
        • Gaziantep Üniversitesi Şahinbey Araştırma ve Uygulama Hastanesi
        • Contact:
        • Principal Investigator:
          • Osman Başpınar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence of safety events
Time Frame: 6 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance, usability:
Time Frame: 6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Occlutech International AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2021

Primary Completion (Estimated)

October 14, 2025

Study Completion (Estimated)

October 14, 2025

Study Registration Dates

First Submitted

December 13, 2021

First Submitted That Met QC Criteria

December 29, 2021

First Posted (Actual)

December 30, 2021

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Occ2021_03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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