EP-Catheter Guided CS-Lead Implantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Fikret Er, University of Cologne
ClinicalTrials.gov Identifier:
NCT01922544
First received: August 11, 2013
Last updated: August 13, 2013
Last verified: August 2013

August 11, 2013
August 13, 2013
August 2013
August 2013   (final data collection date for primary outcome measure)
  • Total Fluoroscopy Time [ Time Frame: During implantation ] [ Designated as safety issue: Yes ]
    During CRT device implantation fluoroscopy is used and the total fluoroscopy time is counted.
  • Contrast medium account [ Time Frame: During surgical procedure ] [ Designated as safety issue: Yes ]
    contrast medium is used and counted during crt device implantation.
Same as current
Complete list of historical versions of study NCT01922544 on ClinicalTrials.gov Archive Site
Successful implantation [ Time Frame: During surgical procedure ] [ Designated as safety issue: No ]
Successful crt implantation was defined as effective positioning of RV and CS lead +/- right atrial lead.
Same as current
Procedure related complications [ Time Frame: 24 hours after start of surgery ] [ Designated as safety issue: Yes ]
All complications during time frame of 24 hours after start of surgery were proved whether they were procedure related.
Same as current
 
EP-Catheter Guided CS-Lead Implantation
Conventional Versus EP-Catheter Guided Implantation of Coronary Sinus Lead in Patients Undergoing Cardiac Resynchronization Therapy

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

Patients with symptomatic heart failure and reduced left ventricular ejection fraction. Asynchronic contraction of left and right ventricle was reflected by QRS duration > 120 ms in left precordial leads.

  • Heart Failure
  • Reduced Left Ventricular Ejection Fraction
  • Left Bundle Branch Block
Not Provided
  • Conventional group
    In this group CS lead was implanted in a conventional manner.
  • EP-catheter group
    In this group coronary sinus was canulated using a steerable electrophysiology catheter.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
August 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • CRT implantation due to heart failure
  • full documented data

Exclusion Criteria:

  • previous pacemaker/ICD/CRT implantation
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01922544
CRT1
Yes
Dr. Fikret Er, University of Cologne
University of Cologne
Not Provided
Not Provided
University of Cologne
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP