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OpenTrials
Completed

NCT Number: NCT01922544

EP-Catheter Guided CS-Lead Implantation

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.

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Key information

Conditions

Heart Failure Arrhythmias, Cardiac Bundle-Branch Block Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Left Bundle Branch Block Pathologic Processes Pathological Conditions, Signs and Symptoms Reduced Left Ventricular Ejection Fraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • CRT implantation due to heart failure
  • full documented data

Exclusion criteria

  • previous pacemaker/ICD/CRT implantation

Treatment and study plan

Primary outcomes

  1. Total Fluoroscopy Time

    Time frame: During implantation

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

  2. Contrast medium account

    Time frame: During surgical procedure

    contrast medium is used and counted during crt device implantation.

Secondary outcomes

  1. Successful implantation

    Time frame: During surgical procedure

    Successful crt implantation was defined as effective positioning of RV and CS lead +/- right atrial lead.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study title

Conventional Versus EP-Catheter Guided Implantation of Coronary Sinus Lead in Patients Undergoing Cardiac Resynchronization Therapy

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 14, 2013
Registry last updated
Aug 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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