EP-Catheter Guided CS-Lead Implantation

August 13, 2013 updated by: Dr. Fikret Er, University of Cologne

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Cologne, NRW, Germany, 50937
        • University of Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • CRT implantation due to heart failure
  • full documented data

Exclusion Criteria:

  • previous pacemaker/ICD/CRT implantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Fluoroscopy Time
Time Frame: During implantation
During CRT device implantation fluoroscopy is used and the total fluoroscopy time is counted.
During implantation
Contrast medium account
Time Frame: During surgical procedure
contrast medium is used and counted during crt device implantation.
During surgical procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful implantation
Time Frame: During surgical procedure
Successful crt implantation was defined as effective positioning of RV and CS lead +/- right atrial lead.
During surgical procedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours after start of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

August 11, 2013

First Submitted That Met QC Criteria

August 13, 2013

First Posted (Estimate)

August 14, 2013

Study Record Updates

Last Update Posted (Estimate)

August 14, 2013

Last Update Submitted That Met QC Criteria

August 13, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRT1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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