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 |
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Heart Diseases |
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 |
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:
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
All subjects who underwent implantation procedure with an Occlutech accessory medical device and cardiac implants can be included
Exclusion Criteria:
Contact: Gönül Sönmez Utkun | +90 542 826 11 95 | gonul.sonmezutkun@occlutech.com |
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 |
Tracking Information | |||||
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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 |
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:
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Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures |
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.
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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. |
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Detailed Description | Not Provided | ||||
Study Type | Observational [Patient Registry] | ||||
Study Design | Observational Model: Other Time Perspective: Other |
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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. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
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:
All subjects who underwent implantation procedure with an Occlutech accessory medical device and cardiac implants can be included Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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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 |
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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 |