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

NCT ID: NCT02247817

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31

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.

Conditions

Heart Failure With Intraventricular Conduction Delay

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HYBRID

Hybrid transvenous/epicardial implantation of a CRT-(D) device.

Group Type: EXPERIMENTAL

Hybrid CRT-D/P implantation

Intervention Type: DEVICE

Interventions

Hybrid CRT-D/P implantation

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Jasper J. Schouwenburg

Drs.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

METc 2013/387

Identifier Type: -

Identifier Source: org_study_id