Coronary Sinus Reducer Implantation for Refractory Angina - Long-Term Evaluation of Device Safety and Efficacy- Lower Silesia Sinus Reducer Registry (LSSRR)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• present of chronic disabling refractory angina pectoris (Canadian Cardiovascular Society \[CCS\] classes 2-4) despite maximally tolerated anti-angina medical therapy

• Heart team evaluation with consideration of ineligibility for percutaneous or surgical revascularization procedures.

Locations
Other Locations
Poland
Cardiac Department of Copper Health Center
RECRUITING
Lubin
Department of Cardiology, The Copper Health Centre (MCZ)
RECRUITING
Lubin
Contact Information
Primary
Adrian Włodarczak, Prof.
wlodarczak.adrian@gmail.com
0048768460-285
Backup
Szymon Włodarczak, MD
wlodarczak.szy@gmail.com
0048 693-350-846
Time Frame
Start Date: 2022-05-11
Estimated Completion Date: 2027-05-11
Participants
Target number of participants: 200
Treatments
Coronary Sinus Reducer implantation
Subject after Coronary Sinus Reducer implantation due to chronic disabling refractory angina pectoris (Canadian Cardiovascular Society \[CCS\] classes 2-4) despite maximally tolerated anti-angina medical therapy. All patients were evaluated by the local Heart Team and considered not amenable to percutaneous or surgical revascularization procedures. After the Heart Team evaluation patients were qualified for the procedure or Coronary Sinus Reducer implantation unless they meet one of the exclusion criteria. Initial patient evaluation (prior to device implantation) consists of past medical history, actual clinical assessment with an evaluation of CCS class, Seattle Angina Questionnaire - 7 items (SAQ-7) scores, 6-min walk distance (6-MWT) test, and echocardiography. First, a follow-up visit is scheduled 1 month after the implantation procedure than the follow-up is planned twice a year.
Related Therapeutic Areas
Sponsors
Leads: Regional Cardiology Center, The Copper Health Centre (MCZ),

This content was sourced from clinicaltrials.gov