4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / ACCESS Registry_A Registry-based, Multicenter, International, Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory Medical Devices

ACCESS Registry_A Registry-based, Multicenter, International, Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory Medical Devices

Study Description
Brief Summary:

The present registry is international, multicenter, non-randomized, non-invasive study to assess the Safety, performance and usability of Occlutech Accessories" Occlutech Delivery Set (ODS), Occlutech Pistol Pusher (OPP), Occlutech Occlusions-Pusher (OOP), Occlutech Sizing Balloon (OSB)" used for implantation procedures (catheter-based interventions) of cardiac implants via completing survey (questionnaire) for each accessory medical devices by investigator.

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. Survey (questionnaire) will 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.


Condition or disease
Heart Diseases

Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 880 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 6 Months
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
Actual Study Start Date : October 14, 2021
Estimated Primary Completion Date : October 14, 2025
Estimated Study Completion Date : October 14, 2025
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Safety [ 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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Gönül Sönmez Utkun +90 542 826 11 95 gonul.sonmezutkun@occlutech.com

Locations
Layout table for location information
Turkey
Sağlık Bilimleri Üniversitesi Dışkapı Yıldırım Beyazıt Eğitim ve Araştırma Hastanesi Recruiting
Ankara, Dışkapı, Turkey
Contact: I. Hakan Güllü, MD    0532 052 14 26    drgullu@gmail.com   
Principal Investigator: I. Hakan Güllü, MD         
İzmir Sağlik Bilimleri Üniversitesi Tepecik Eğitim Ve Araştirma Hastanesi Recruiting
İzmir, Konak, Turkey
Contact: Barış Kılıçaslan, MD    0505 588 81 88    kiliaslanbaris@yahoo.com   
Principal Investigator: Barış Kılıçaslan, MD         
Sponsors and Collaborators
Occlutech International AB
Tracking Information
First Submitted Date December 13, 2021
First Posted Date December 30, 2021
Last Update Posted Date December 30, 2021
Actual Study Start Date October 14, 2021
Estimated Primary Completion Date October 14, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 29, 2021)
Safety [ 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 29, 2021)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ACCESS Registry_A Registry-based, Multicenter, International, Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory Medical Devices
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
Brief Summary

The present registry is international, multicenter, non-randomized, non-invasive study to assess the Safety, performance and usability of Occlutech Accessories" Occlutech Delivery Set (ODS), Occlutech Pistol Pusher (OPP), Occlutech Occlusions-Pusher (OOP), Occlutech Sizing Balloon (OSB)" used for implantation procedures (catheter-based interventions) of cardiac implants via completing survey (questionnaire) for each accessory medical devices by investigator.

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. Survey (questionnaire) will 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.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration 6 Months
Biospecimen Not Provided
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.
Condition Heart Diseases
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 29, 2021)
880
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 14, 2025
Estimated Primary Completion Date October 14, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Gönül Sönmez Utkun +90 542 826 11 95 gonul.sonmezutkun@occlutech.com
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT05174442
Other Study ID Numbers Occ2021_03
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Occlutech International AB
Study Sponsor Occlutech International AB
Collaborators Not Provided
Investigators Not Provided
PRS Account Occlutech International AB
Verification Date October 2021