NCT01922544

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
Last Updated

August 14, 2013

Status Verified

August 1, 2013

Enrollment Period

Same day

First QC Date

August 11, 2013

Last Update Submit

August 13, 2013

Conditions

Heart FailureReduced Left Ventricular Ejection FractionLeft Bundle Branch Block

Keywords

heart failurecardiac resynchronization therapycoronary sinus lead

Outcome Measures

Primary Outcomes (2)

  • Total Fluoroscopy Time

    During CRT device implantation fluoroscopy is used and the total fluoroscopy time is counted.

    During implantation

  • Contrast medium account

    contrast medium is used and counted during crt device implantation.

    During surgical procedure

Secondary Outcomes (1)

  • Successful implantation

    During surgical procedure

Other Outcomes (1)

  • Procedure related complications

    24 hours after start of surgery

Study Arms (2)

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • CRT implantation due to heart failure
  • full documented data

You may not qualify if:

  • previous pacemaker/ICD/CRT implantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

MeSH Terms

Conditions

Heart FailureBundle-Branch Block

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHeart BlockArrhythmias, CardiacCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 11, 2013

First Posted

August 14, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

August 14, 2013

Record last verified: 2013-08

Locations

DE(1)