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EP-Catheter Guided CS-Lead Implantation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01922544
First Posted: August 14, 2013
Last Update Posted: August 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Fikret Er, University of Cologne
  Purpose
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.

Condition
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)
Groups/Cohorts
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.

  Eligibility

Information from the National Library of Medicine

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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.
Criteria

Inclusion Criteria:

  • CRT implantation due to heart failure
  • full documented data

Exclusion Criteria:

  • previous pacemaker/ICD/CRT implantation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01922544


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

Responsible Party: Dr. Fikret Er, Dr., University of Cologne
ClinicalTrials.gov Identifier: NCT01922544     History of Changes
Other Study ID Numbers: CRT1
First Submitted: August 11, 2013
First Posted: August 14, 2013
Last Update Posted: August 14, 2013
Last Verified: August 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