Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288165
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2024-02-18
Brief Title:
Lower Silesia Sinus Reducer Registry
Sponsor:
Regional Cardiology Center The Copper Health Centre MCZ
Organization:
Regional Cardiology Center The Copper Health Centre MCZ
Study Overview
Official Title:
Coronary Sinus Reducer Implantation for Refractory Angina - Long-Term Evaluation of Device Safety and Efficacy- Lower Silesia Sinus Reducer Registry LSSRR
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LSSRR
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
Detailed Description:
Lower Silesia Sinus Reducer Registry is a single-center single-arm registry including all consecutive patients who were referred to the Cardiac Department of Copper Health Center due to chronic disabling refractory angina pectoris Canadian Cardiovascular Society CCS classes 2-4 despite maximally tolerated anti-angina medical therapy and underwent Coronary Sinus Reducer implantation 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 met one of the exclusion criteria
Initial patient evaluation prior to device implantation consisted 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 was scheduled 1 month after the implantation procedureThe study will include clinical assessments every six months during an observation period The primary outcomes will be gathered one year after the implantation of the CS Nevertheless clinical follow-up will continue for up to five years after the procedure
Initial patient evaluation prior to device implantation consisted 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 was scheduled 1 month after the implantation procedureThe study will include clinical assessments every six months during an observation period The primary outcomes will be gathered one year after the implantation of the CS Nevertheless clinical follow-up will continue for up to five years after the procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None