Heart FailureEK138/08NCT00764075
Guided Placement of CRT-Leads
A study testing Beutel TM, standard and software Beutel TM in people with Heart Failure, run by RWTH Aachen University at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Beutel TM, standard and software Beutel TM
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2008to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Congestive heart failure,
- Ejection fraction <35%,
- Complete left bundle branch block >120ms,
- NYHA II,III or IV
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: CT and 3D-Echocardiography Placement of CRT-Leads
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Beutel TM, standard, software Beutel TM
- Keywords
- heart failure; EF<35%; NYHA II, III or IV
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beutel TMDevice
application of BeutelTM
standardOther
standard procedure will be applied but no Beutel TM software
software Beutel TMDevice
application of BeutelTM to patients data for determination of site of latest contraction
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | guided implantation of the left ventricular lead Receives: Device: Beutel TM |
| 2 | Placebo comparator | standard implantation of the left ventricular lead Receives: Other: standard |
| Pilot Group | Experimental | feasibility of guided placement of CRT-leads in 20 Patients Receives: Device: software Beutel TM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of non-responders regarding ejection fraction
Measured: 6 months
Secondary outcomes (1)
rate of non-responders regarding NYHA-classification, left end-diastolic and end-systolic volume
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionApr 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago
- Investigators
- Christian Knackstedt, MD, Principal investigator, RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764075
- Sponsor's protocol ID
- CRT-Study
- Acronym
- EK138/08
- Status last verified
- Jul 2011
- First submitted
- 26 Sep 2008
- Last updated
- 7 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT and 3D-Echocardiography Placement of CRT-Leads
- ClinicalTrials.gov ID
- NCT00764075
- Acronym / sponsor ID
- EK138/08 / CRT-Study
- Conditions
- Heart Failure
- Keywords
- heart failure; EF<35%; NYHA II, III or IV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- University of Chicago
- Study start
- Oct 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 1 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Beutel TMguided implantation of the left ventricular lead |
| 2 | Placebo comparator | Other: standardstandard implantation of the left ventricular lead |
| Pilot Group | Experimental | Device: software Beutel TMfeasibility of guided placement of CRT-leads in 20 Patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Congestive heart failure,
- Ejection fraction <35%,
- Complete left bundle branch block >120ms,
- NYHA II,III or IV
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beutel TMapplication of BeutelTM | Device | 1 |
| standardstandard procedure will be applied but no Beutel TM software | Other | 2 |
| software Beutel TMapplication of BeutelTM to patients data for determination of site of latest contraction | Device | Pilot Group |
Primary outcome
Rate of non-responders regarding ejection fraction
Time frame: 6 months
1 secondary outcome
rate of non-responders regarding NYHA-classification, left end-diastolic and end-systolic volume
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Knackstedt, MD principal investigator
RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beutel TM, standard and software Beutel TM in people with Heart Failure, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of non-responders regarding ejection fraction (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2011.