A combined transvenous and epicardial lead placement procedure for implantation of cardiac resynchronization devices: a feasibility study

Phase 2

Completed

• Conditions: 10019280; pump failure; Heart failure

• Registration Number: NL-OMON40512
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Left ventricular ejection fraction < 36%.
2. Intraventricular conduction delay >119 ms of >129 ms and presence of left bundle branch block.
3. On optimal medical therapy for heart failure.
4. No sidebranch of the coronary sinus near the posterolateral wall of the left ventricle and/or presence of a Thebesian valve which reduces coronary sinus diameter 50% or more (corresponding to a decrease in cross sectional area of 75% or more).
5. Signed informed consent.

Exclusion Criteria

1. Previous intrathoracic surgery
2. Coronary ischemia or recent myocardial infarction (< 6 months)
3. Suspected presence of a non-compliant left lung.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Number of succesful device implantations.<br /><br>The procedure is considerd succesfol when implantation of a CRT device succeeds<br /><br>in all study patients through the procedure described above. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Safety.<br /><br>The procedure is considerd safe when no procedure related deaths occur and<br /><br>procedure related complications occur in three patients or less.<br /><br>2. Conversion to minithoracotomy. </p><br>