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

Heart Diseases Clinical Trial

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

Status Recruiting

Clinical Trial Summary

Clinical Trial 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 Design

Related Conditions & MeSH terms

Heart Diseases

Clinical Trial Details

NCT number	NCT05174442
Study type	Observational [Patient Registry]
Source	Occlutech International AB
Contact	Gönül Sönmez Utkun
Phone	+90 542 826 11 95
Email	gonul.sonmezutkun@occlutech.com
Status	Recruiting
Phase
Start date	October 14, 2021
Completion date	October 14, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04624412` - Different Intensities of Continuous Aerobic Exercises in Cardiac Rehab Phase 2	N/A
Completed	`NCT05563701` - Evaluation of the LVivo Image Quality Scoring (IQS)
Recruiting	`NCT04561908` - Transcatheter Microguidewire Drilling for Transseptal Left Atrial Access	N/A
Active, not recruiting	`NCT06190743` - Perception of Cardiovascular Risk
Completed	`NCT04580095` - Artificial Intelligence for Improved Echocardiography	N/A
Completed	`NCT04562636` - Evaluating a Messaging Campaign in the United States	N/A
Recruiting	`NCT03277365` - MyGeneRank: A Digital Platform for Next-Generation Genetic Studies	N/A
Active, not recruiting	`NCT05553106` - Evaluation of Cognitive Status, Kinesiophobia, Physical Activity Level, and Functional Performance in Coronary Intensive Care
Completed	`NCT03429920` - Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors	N/A
Recruiting	`NCT04390672` - Multivessel TALENT	N/A
Enrolling by invitation	`NCT03314818` - Natural History of Carotid Plaque as Determined by 3D Ultrasound	N/A
Withdrawn	`NCT03289104` - Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX	N/A
Completed	`NCT02917213` - Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
Completed	`NCT02046902` - Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection
Completed	`NCT01944254` - The Precision of Pulmonary Artery Cardiac Output-measurements in Spontaneously Breathing Patients	N/A
Completed	`NCT01909349` - Web-based Aftercare Intervention for Cardiac Patients	N/A
Recruiting	`NCT01457586` - Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery	Phase 4
Recruiting	`NCT01207167` - Mediators of Atherosclerosis in South Asians Living in America
Recruiting	`NCT01541163` - Heart and Ischemic STrOke Relationship studY	N/A
Terminated	`NCT00968383` - Cardiovascular Magnetic Resonance for the Occluded Infarct-Related Artery Treatment	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.