Guided Placement of CRT-Leads (EK138/08)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Beutel TM
standard
software Beutel TM
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring heart failure; EF<35%; NYHA II, III or IV
Eligibility Criteria
Inclusion Criteria:
- Congestive heart failure,
- Ejection fraction <35%,
- Complete left bundle branch block >120ms,
- NYHA II,III or IV
Exclusion Criteria:
- Patients not fulfilling the inclusion criteria or not capable/mental able to understand and follow the instructions;
- Impaired kidney function (GFR <30ml/min;
- Pregnant or breastfeeding women
Sites / Locations
- Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
1
2
Pilot Group
Arm Description
guided implantation of the left ventricular lead
standard implantation of the left ventricular lead
feasibility of guided placement of CRT-leads in 20 Patients
Outcomes
Primary Outcome Measures
Rate of non-responders regarding ejection fraction
Secondary Outcome Measures
rate of non-responders regarding NYHA-classification, left end-diastolic and end-systolic volume
Full Information
NCT ID
NCT00764075
First Posted
September 26, 2008
Last Updated
July 6, 2011
Sponsor
RWTH Aachen University
Collaborators
University of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT00764075
Brief Title
Guided Placement of CRT-Leads
Acronym
EK138/08
Official Title
CT and 3D-Echocardiography Placement of CRT-Leads
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
RWTH Aachen University
Collaborators
University of Chicago
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this open, prospective, randomized, parallel group, German-American, two-center, Phase I study the standard-approach CRT-implantation will be compared to a guided CRT-implantation after determining the site of latest contraction and placement of the electrode as close as possible to this site, using a 5-step-scheme of imaging methods determining the site of latest contraction prior to implantation.
Detailed Description
Patients will be allocated to two groups with either
Guided implantation of the left ventricular lead
Empirical implantation of the left ventricular lead (current clinical standard)
For Treatment Group a) the target vessel, which is the vessel with smallest distance between RLC and CVS is determined in advance and provided to the implanting physician. In case, this vessel is not amenable for lead positioning, a second vessel which is the second closest to the RLC is defined.
For Treatment Group b), the physician has to choose the vessel where to place the electrode without knowing the exact spatial orientation between that particular side-branch and the RLC.
In all patients, standard biventricular devices and leads are to be used. Aspects that are evaluated are:
Technical success in placing the electrode in the target vessel.
Failure due to dislocation during the implantation procedure or phrenic nerve stimulation.
Also, procedure duration, radiation exposure, and complications occurring during the procedure as well as post- operatively will be documented.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure; EF<35%; NYHA II, III or IV
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
guided implantation of the left ventricular lead
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
standard implantation of the left ventricular lead
Arm Title
Pilot Group
Arm Type
Experimental
Arm Description
feasibility of guided placement of CRT-leads in 20 Patients
Intervention Type
Device
Intervention Name(s)
Beutel TM
Intervention Description
application of BeutelTM
Intervention Type
Other
Intervention Name(s)
standard
Intervention Description
standard procedure will be applied but no Beutel TM software
Intervention Type
Device
Intervention Name(s)
software Beutel TM
Intervention Description
application of BeutelTM to patients data for determination of site of latest contraction
Primary Outcome Measure Information:
Title
Rate of non-responders regarding ejection fraction
Time Frame
6 months
Secondary Outcome Measure Information:
Title
rate of non-responders regarding NYHA-classification, left end-diastolic and end-systolic volume
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Congestive heart failure,
Ejection fraction <35%,
Complete left bundle branch block >120ms,
NYHA II,III or IV
Exclusion Criteria:
Patients not fulfilling the inclusion criteria or not capable/mental able to understand and follow the instructions;
Impaired kidney function (GFR <30ml/min;
Pregnant or breastfeeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Knackstedt, MD
Organizational Affiliation
RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Guided Placement of CRT-Leads
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