Registry for patients with refractory angina undergoing Coronary Sinus Reducer implantation
Coronary Sinus Reducer Implantation for Refractory Angina - Long-Term Evaluation of Device Safety and Efficacy- Lower Silesia Sinus Reducer Registry (LSSRR)
This study is testing if a new device called the Coronary Sinus Reducer can help people with severe chest pain who haven't found relief from other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regional Cardiology Center, The Copper Health Centre (MCZ), Academic / other |
| Locations | 2 sites (Lubin, Lower Silesian Voivodeship and 1 other locations) |
| Trial ID | NCT06288165 on ClinicalTrials.gov |
What this trial studies
The Lower Silesia Sinus Reducer Registry is an observational, single-center registry that includes patients suffering from chronic disabling refractory angina pectoris, classified as CCS classes 2-4, who have not responded to maximally tolerated anti-angina medical therapy. Patients undergo a thorough evaluation by a Heart Team to determine their eligibility for Coronary Sinus Reducer implantation, as they are not suitable for other revascularization procedures. Initial assessments include medical history, clinical evaluations, and various tests, with follow-up visits scheduled at one month and every six months thereafter for up to five years to monitor outcomes. The primary outcomes will be assessed one year post-implantation.
Who should consider this trial
Good fit: Ideal candidates are individuals with chronic disabling refractory angina pectoris who are not eligible for surgical or percutaneous revascularization.
Not a fit: Patients with recent acute coronary syndrome, advanced heart failure, or those who are candidates for other cardiac interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients with refractory angina who have limited treatment options.
How similar studies have performed: While the specific approach of the Coronary Sinus Reducer is relatively novel, similar interventions for refractory angina have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lubin, Lower Silesian Voivodeship and 1 other locations
- Department of Cardiology, The Copper Health Centre (MCZ) — Lubin, Lower Silesian Voivodeship, Poland (Recruiting)
- Cardiac Department of Copper Health Center — Lubin, Lower Silesian Voivodeship, Poland (Recruiting)
Study contacts
- Study coordinator: Adrian Włodarczak, Prof.
- Email: wlodarczak.adrian@gmail.com
- Phone: 0048768460-285
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.