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EP-Catheter Guided CS-Lead Implantation

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

Heart Failure Reduced Left Ventricular Ejection Fraction Left Bundle Branch Block

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Conventional Versus EP-Catheter Guided Implantation of Coronary Sinus Lead in Patients Undergoing Cardiac Resynchronization Therapy

Resource links provided by NLM:

Further study details as provided by Dr. Fikret Er, University of Cologne:

Primary Outcome Measures:
  • Total Fluoroscopy Time [ Time Frame: During implantation ]
    During CRT device implantation fluoroscopy is used and the total fluoroscopy time is counted.

  • Contrast medium account [ Time Frame: During surgical procedure ]
    contrast medium is used and counted during crt device implantation.

Secondary Outcome Measures:
  • Successful implantation [ Time Frame: During surgical procedure ]
    Successful crt implantation was defined as effective positioning of RV and CS lead +/- right atrial lead.

Other Outcome Measures:
  • Procedure related complications [ Time Frame: 24 hours after start of surgery ]
    All complications during time frame of 24 hours after start of surgery were proved whether they were procedure related.

Enrollment: 120
Study Start Date: August 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.

Inclusion Criteria:

  • CRT implantation due to heart failure
  • full documented data

Exclusion Criteria:

  • previous pacemaker/ICD/CRT implantation
  Contacts and Locations
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Please refer to this study by its identifier: NCT01922544

University of Cologne
Cologne, NRW, Germany, 50937
Sponsors and Collaborators
University of Cologne
  More Information

Responsible Party: Dr. Fikret Er, Dr., University of Cologne Identifier: NCT01922544     History of Changes
Other Study ID Numbers: CRT1
Study First Received: August 11, 2013
Last Updated: August 13, 2013

Keywords provided by Dr. Fikret Er, University of Cologne:
heart failure
cardiac resynchronization therapy
coronary sinus lead

Additional relevant MeSH terms:
Heart Failure
Bundle-Branch Block
Heart Diseases
Cardiovascular Diseases
Heart Block
Arrhythmias, Cardiac
Pathologic Processes processed this record on September 19, 2017