EP-Catheter Guided CS-Lead Implantation

Heart Failure Clinical Trial

Official title:

Conventional Versus EP-Catheter Guided Implantation of Coronary Sinus Lead in Patients Undergoing Cardiac Resynchronization Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01922544
• Other study ID #: CRT1
• Status: Completed
• Phase: N/A
• First received: August 11, 2013
• Last updated: August 13, 2013
• Start date: August 2013
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• CRT implantation due to heart failure

• full documented data

Exclusion Criteria:

• previous pacemaker/ICD/CRT implantation

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Bundle-Branch Block
• Heart Failure
• Left Bundle Branch Block
• Reduced Left Ventricular Ejection Fraction

Locations

Country	Name	City	State
Germany	University of Cologne	Cologne	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Procedure related complications	All complications during time frame of 24 hours after start of surgery were proved whether they were procedure related.	24 hours after start of surgery	Yes
Primary	Total Fluoroscopy Time	During CRT device implantation fluoroscopy is used and the total fluoroscopy time is counted.	During implantation	Yes
Primary	Contrast medium account	contrast medium is used and counted during crt device implantation.	During surgical procedure	Yes
Secondary	Successful implantation	Successful crt implantation was defined as effective positioning of RV and CS lead +/- right atrial lead.	During surgical procedure	No