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

Primary Purpose

Heart Failure With Intraventricular Conduction Delay

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Hybrid CRT-D/P implantation

About this trial

This is an interventional treatment trial for Heart Failure With Intraventricular Conduction Delay

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HYBRID

Arm Description

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

Outcomes

Primary Outcome Measures

Number of procedure related serious adverse events

Secondary Outcome Measures

Full Information

NCT ID

NCT02247817

First Posted

September 20, 2014

Last Updated

September 20, 2014

Sponsor

University Medical Center Groningen

1. Study Identification

Unique Protocol Identification Number

NCT02247817

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Unknown status

Study Start Date

October 2014 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Medical Center Groningen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure With Intraventricular Conduction Delay

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HYBRID

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Hybrid CRT-D/P implantation

Primary Outcome Measure Information:

Title

Number of procedure related serious adverse events

Time Frame

30 days after implantation of device

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

12. IPD Sharing Statement

Learn more about this trial

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

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