Prospective, Non-randomized, Safety and Efficacy Study of a New Occluder Design for Minimally Inv… (NCT02105584) | Clinical Trial Compass
CompletedNot Applicable
Prospective, Non-randomized, Safety and Efficacy Study of a New Occluder Design for Minimally Invasive Closure of the Left Atrial Appendage (LAA) in Patients With Atrial Fibrillation
Germany, United Kingdom78 participantsStarted 2014-04
Plain-language summary
This is a prospective, non-randomized, study of the safety and efficacy of the Occlutech® LAA occluder indicated for percutaneous LAA closure in adult male or female patients with atrial fibrillation. Safety and efficacy will be assessed at day 1, 30 and 90, and after 1 year following implantation of an Occlutech® LAA Occluder.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Documented paroxysmal, persistent or chronic non-valvular AF
* Calculated CHA2DS2 -VASC score equal or greater than 2 and/or HAS-BLED score equal or greater than 2
* Patients eligible or non-eligible for lifelong, oral anticoagulation therapy
* Life expectancy of at least 1 year
* Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
Exclusion Criteria:
* Suspected or known intracardiac thrombus
* NYHA Class IV CHF
* Patients who has unstable and intractable angina pectoris
* ASD and/or atrial septal repair or closure device
* Recent myocardial infarction within 3 months
* Severe valvular heart disease, or implanted mechanical valve prosthesis
* Large PFO with significant atrial septal aneurysm
* Planned ablation procedure within 30 days of Occlutech LAA occluder® implant
* Resting heart rate \> 110 bpm
* Allergy to Nitinol, which is a result of nickel and/or titanium allergies
* Stroke/TIA within the last 30 days
* Thrombocytopenia, thrombocytosis, leukopenia, or anemia
* Symptomatic carotid artery disease
* LVEF \< 30%
* Mitral valve stenosis
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Successful implantation of the Occlutech LAA closure device with less than 7% occurrence of major complications.