| NCT ID | NCT06288165 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Miedziowe Centrum Zdrowia SA |
| Condition | Safety Issues |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-05-11 |
| Primary Completion | 2027-05-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2022-05-11 with a primary completion date of 2027-05-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Lower Silesia Sinus Reducer Registry is a , single-center, single-arm registry including patients with chronic disabling refractory angina pectoris (Canadian Cardiovascular Society \[CCS\] classes 2-4) despite maximally tolerated anti-angina medical therapy who underwent Coronary Sinus Reducer implantation .
Eligibility Criteria
Inclusion Criteria: 1. present of chronic disabling refractory angina pectoris (Canadian Cardiovascular Society \[CCS\] classes 2-4) despite maximally tolerated anti-angina medical therapy 2. Heart team evaluation with consideration of ineligibility for percutaneous or surgical revascularization procedures. Exclusion Criteria: 1. recent acute coronary syndrome (\<3 months), 2. recent coronary revascularization (\<3 months) 3. a mean right atrial pressure higher than 15 mm Hg 4. coronary sinus proximal diameter \<10mm and \>14mm 5. life expectancy under 12 months, 6. advanced heart failure (New York Heart Association \[NYHA\] Classification - classes 3-4), 7. potential implantable cardiac resynchronization therapy defibrillator (CRT-D) implantation candidate.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06288165 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Safety Issues. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06288165 currently recruiting?
Yes, NCT06288165 is actively recruiting participants. Contact the research team at wlodarczak.adrian@gmail.com for enrollment information.
Where is the NCT06288165 trial being conducted?
This trial is being conducted at Lubin, Poland, Lubin, Poland.
Who is sponsoring the NCT06288165 clinical trial?
NCT06288165 is sponsored by Miedziowe Centrum Zdrowia SA. The trial plans to enroll 200 participants.