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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014