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

Heart Failure With Intraventricular Conduction Delay Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02247817
• Other study ID #: METc 2013/387
• Status: Not yet recruiting
• Phase: N/A
• First received: September 20, 2014
• Last updated: September 20, 2014
• Start date: October 2014

Study information

• Verified date: September 2014
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure With Intraventricular Conduction Delay

Intervention

Device:
• Hybrid CRT-D/P implantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of procedure related serious adverse events		30 days after implantation of device	Yes