EP-Catheter Guided CS-Lead Implantation

Completed

• Conditions: Heart Failure; Reduced Left Ventricular Ejection Fraction; Left Bundle Branch Block

• Registration Number: NCT01922544
• Lead Sponsor: University of Cologne

Brief Summary

In patients undergoing CRT device implantation a lead positioning in the coronary sinus is required. Even this part of the surgical procedure is challenging. In this study we compared retrospectively to methods of CS-lead implantation: conventional vs. EP-catheter guided.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-08
• Study Start: 2013-08
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Study First Submitted: 2013-08-11
• Study First Submitted QC: 2013-08-13
• Last Update Submitted: 2013-08-13
• Study First Posted: 2013-08-14
• Last Update Posted: 2013-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• CRT implantation due to heart failure
• full documented data

Exclusion Criteria

• previous pacemaker/ICD/CRT implantation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total Fluoroscopy Time	During implantation	During CRT device implantation fluoroscopy is used and the total fluoroscopy time is counted.
Contrast medium account	During surgical procedure	contrast medium is used and counted during crt device implantation.

Secondary Outcome Measures

Name	Time	Method
Successful implantation	During surgical procedure	Successful crt implantation was defined as effective positioning of RV and CS lead +/- right atrial lead.

Trial Locations

Locations (1)

University of Cologne; 🇩🇪 Cologne, NRW, Germany