Occlutech Accessory Devices for Cardiac Implant Procedures
The study aims to observe the safety of Occlutech accessory devices during cardiac implant procedures by monitoring for any adverse events or effects in individuals undergoing these procedures.
Data Collection
Cardiovascular Diseases
+ Heart Diseases
Other
Utilizing specific methods not covered by standard models in order to address unique research questions.Summary
Study start date: October 14, 2021
Actual date on which the first participant was enrolled.This study is designed to monitor the safety and performance of several Occlutech accessory devices used during heart implant procedures. These devices—Occlutech Delivery Set, Occlutech Pistol Pusher, Occlutech Occlusions-Pusher, and Occlutech Sizing Balloon—are used in catheter-based interventions to place cardiac implants. The study aims to ensure these tools are safe and effective when used by experienced physicians. By focusing on these aspects, the study aims to improve the procedures for patients needing heart implants, ensuring they are as safe and efficient as possible. Participants in this study are not patients but the physicians using these devices. They complete surveys after using the devices during implant procedures. These surveys ask about the success of the implantation, any adverse effects during or after the procedure, and any harm or deficiencies related to the devices. The study also gathers data on how well the devices perform and how easy they are to use. By analyzing the survey responses, the study assesses the overall safety and effectiveness of the devices in real-world clinical settings.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.685 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 36 locations
Klinikum der Universität München
München, GermanyÇukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi
Adana, Turkey (Türkiye)İnönü Üniversitesi Tıp Fakültesi Hastanesi
Malatya, Turkey (Türkiye)