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
  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 University of Cologne:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01922544

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

No publications provided

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

Keywords provided by University of Cologne:
heart failure
cardiac resynchronization therapy
coronary sinus lead

Additional relevant MeSH terms:
Bundle-Branch Block
Heart Block
Heart Failure
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 22, 2014