A Combined Transvenous and Epicardial Lead Placement Procedure for Implantation of Cardiac Resynchronization Devices: a Feasibility Study.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02247817

Enrollment

Registered

2014-09-25

Start date

2014-10-31

Completion date

Unknown

Last updated

2014-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Intraventricular Conduction Delay

Brief summary

Cardiac resynchronization therapy has become one of the cornerstones of the treatment of heart failure. However, a large proportion of patients still fails to this type of therapy. This may be due to a suboptimal position of the left ventricular pacing lead, which may be caused by unfavorable cardiac venous anatomy. Implantation of the pacing lead using video assisted thoracic surgery is more flexible and evades the venous system altogether, resulting in a much more favorable position of the pacing lead, with better treatment results as e consequence.

Interventions

DEVICEHybrid CRT-D/P implantation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* NYHA class II-III. * Left ventricular ejection fraction ≤ 35%. * QRS-duration of ≥ 120 ms (NYHA III) or ≥ 130 ms (NYHA II) and left bundle branch block morphology. * 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). * On optimal medical therapy for heart failure, including beta-blockers, ACE-inhibitors, AT2-antagonists and aldosteron antagonists. * Age ≥ 18 years. * Signed informed consent.

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study: * Coronary ischemia or a recent myocardial infarction (\< 6 months). * Allready a CRT-device implanted. * Venous thrombosis without options to reach the right heart. * Presence of any other condition than HF with a life expectancy of \< 1 year. * History of intrathoracic surgery. * Presence or suspected presence of a noncompliant left lung. * Participation in another intervention trial. * Unable to understand Dutch language. * Pregnant women.

Design outcomes

Primary

Measure	Time frame
Number of procedure related serious adverse events	30 days after implantation of device

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026