Heart FailureNCT00748735
Left Ventricular Lead Position in Cardiac Resynchronization Therapy
An observational study of Heart Failure, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Left ventricular (LV) lead position has crucial impact on cardiac resynchronization therapy (CRT) success. This study will compare fluoroscopy and myocardial deformation imaging for optimal definition of LV lead position. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Implantation of a cardiac resynchronization therapy device and Echocardiography (myocardial deformation imaging)
- Type of treatment
- Surgery or procedure
- How many people
- 55 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with end-stage heart failure and sinus rhythm, scheduled for new implantation of a biventricular pacemaker were included in the study. Criteria for CRT implantation were New York Heart Association (NYHA) functional class III (N=35) or IV (N=21) despite optimal pharmacologic therapy and evidence of LV systolic dysfunction with ejection fraction <35% and a QRS >120ms.
Who may be able to join
- See above
- Males and females
- Ages 18 to 80 years
Who cannot join
- Patients who already have had a pacemaker device
- Patients with poor echocardiographic window
- Patients who are not able to understand the study and to give informed written consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Cardiology, RWTH Aachen University Hospital
Aachen, 52057
About this study
Official title: Optimal Definition of Left Ventricular Lead Position in Cardiac Resynchronization Therapy by Myocardial Deformation Imaging
Left ventricular (LV) lead position has crucial impact on cardiac resynchronization therapy (CRT) success. This study will compare fluoroscopy and myocardial deformation imaging for optimal definition of LV lead position.
Read the detailed description
In a 16 segment model circumferential strain will be used to determine the segment with latest peak systolic circumferential strain prior to CRT, considered as the optimal LV lead target. LV lead will be defined by (1) fluoroscopy, (2) the maximal temporal difference of peak circumferential strain before-to-on CRT and (3) the earliest peak systolic circumferential strain during LV pacing. For all 3 modalities optimal LV lead position is defined as concordance or immediate neighbouring of the segment with defined LV lead position to the determined optimal target segment. At follow-up echocardiography will be performed to determine improvement in LV function and remodeling.
- Conditions
- Heart Failure
- Being tested
- Implantation of a cardiac resynchronization therapy device, Echocardiography (myocardial deformation imaging)
- Keywords
- cardiac resynchronization therapy, echocardiography, heart failure, left ventricular function, pacing, myocardial deformation imaging, Optimal Definition of Left Ventricular Lead Position in Cardiac Resynchronization Therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of a cardiac resynchronization therapy deviceProcedure or surgery
Echocardiography (myocardial deformation imaging)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| A1 | heart failure patients undergoing CRT implantation Receives: Procedure: Implantation of a cardiac resynchronization therapy device; Procedure: Echocardiography (myocardial deformation imaging) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in LV function and LV remodelling
Measured: 6 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Investigators
- Michael Becker, MD, Principal investigator, RWTH Aachen University HospitalRainer Hoffmann, MD, Study chair, RWTH Aachen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748735
- Sponsor's protocol ID
- MB-2008-CRT
- Status last verified
- Jan 2008
- First submitted
- 7 Sep 2008
- Last updated
- 9 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Becker M, Franke A, Breithardt OA, Ocklenburg C, Kaminski T, Kramann R, Knackstedt C, Stellbrink C, Hanrath P, Schauerte P, Hoffmann R. Impact of left ventricular lead position on the efficacy of cardiac resynchronisation therapy: a two-dimensional strain echocardiography study. Heart. 2007 Oct;93(10):1197-203. doi: 10.1136/hrt.2006.095612. Epub 2007 Feb 19.
PubMed 17309913Becker M, Kramann R, Franke A, Breithardt OA, Heussen N, Knackstedt C, Stellbrink C, Schauerte P, Kelm M, Hoffmann R. Impact of left ventricular lead position in cardiac resynchronization therapy on left ventricular remodelling. A circumferential strain analysis based on 2D echocardiography. Eur Heart J. 2007 May;28(10):1211-20. doi: 10.1093/eurheartj/ehm034. Epub 2007 Apr 10.
PubMed 17426079Becker M, Altiok E, Ocklenburg C, Krings R, Adams D, Lysansky M, Vogel B, Schauerte P, Knackstedt C, Hoffmann R. Analysis of LV lead position in cardiac resynchronization therapy using different imaging modalities. JACC Cardiovasc Imaging. 2010 May;3(5):472-81. doi: 10.1016/j.jcmg.2009.11.016.
PubMed 20466342
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Definition of Left Ventricular Lead Position in Cardiac Resynchronization Therapy by Myocardial Deformation Imaging
- ClinicalTrials.gov ID
- NCT00748735
- Acronym / sponsor ID
- MB-2008-CRT
- Conditions
- Heart Failure
- Keywords
- cardiac resynchronization therapy, echocardiography, heart failure, left ventricular function, pacing, myocardial deformation imaging, Optimal Definition of Left Ventricular Lead Position in Cardiac Resynchronization Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- First posted
- 9 Sep 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.
Left ventricular (LV) lead position has crucial impact on cardiac resynchronization therapy (CRT) success. This study will compare fluoroscopy and myocardial deformation imaging for optimal definition of LV lead position.
Detailed description
In a 16 segment model circumferential strain will be used to determine the segment with latest peak systolic circumferential strain prior to CRT, considered as the optimal LV lead target. LV lead will be defined by (1) fluoroscopy, (2) the maximal temporal difference of peak circumferential strain before-to-on CRT and (3) the earliest peak systolic circumferential strain during LV pacing. For all 3 modalities optimal LV lead position is defined as concordance or immediate neighbouring of the segment with defined LV lead position to the determined optimal target segment. At follow-up echocardiography will be performed to determine improvement in LV function and remodeling.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A1 | – | Procedure: Implantation of a cardiac resynchronization therapy device, Procedure: Echocardiography (myocardial deformation imaging)heart failure patients undergoing CRT implantation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with end-stage heart failure and sinus rhythm, scheduled for new implantation of a biventricular pacemaker were included in the study. Criteria for CRT implantation were New York Heart Association (NYHA) functional class III (N=35) or IV (N=21) despite optimal pharmacologic therapy and evidence of LV systolic dysfunction with ejection fraction <35% and a QRS >120ms.
Key inclusion criteria (3 listed)
- See above
- Males and females
- Ages 18 to 80 years
Key exclusion criteria (3 listed)
- Patients who already have had a pacemaker device
- Patients with poor echocardiographic window
- Patients who are not able to understand the study and to give informed written consent
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 |
|---|---|---|
| Implantation of a cardiac resynchronization therapy device | Procedure or surgery | A1 |
| Echocardiography (myocardial deformation imaging) | Procedure or surgery | A1 |
Primary outcome
Improvement in LV function and LV remodelling
Time frame: 6 to 12 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 9 Sep 2008.
- Background: PubMed 17309913Becker M, Franke A, Breithardt OA, Ocklenburg C, Kaminski T, Kramann R, Knackstedt C, Stellbrink C, Hanrath P, Schauerte P, Hoffmann R. Impact of left ventricular lead position on the efficacy of cardiac resynchronisation therapy: a two-dimensional strain echocardiography study. Heart. 2007 Oct;93(10):1197-203. doi: 10.1136/hrt.2006.095612. Epub 2007 Feb 19.
- Background: PubMed 17426079Becker M, Kramann R, Franke A, Breithardt OA, Heussen N, Knackstedt C, Stellbrink C, Schauerte P, Kelm M, Hoffmann R. Impact of left ventricular lead position in cardiac resynchronization therapy on left ventricular remodelling. A circumferential strain analysis based on 2D echocardiography. Eur Heart J. 2007 May;28(10):1211-20. doi: 10.1093/eurheartj/ehm034. Epub 2007 Apr 10.
- Derived from this study: PubMed 20466342Becker M, Altiok E, Ocklenburg C, Krings R, Adams D, Lysansky M, Vogel B, Schauerte P, Knackstedt C, Hoffmann R. Analysis of LV lead position in cardiac resynchronization therapy using different imaging modalities. JACC Cardiovasc Imaging. 2010 May;3(5):472-81. doi: 10.1016/j.jcmg.2009.11.016.
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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.
Michael Becker, MD principal investigator
RWTH Aachen University Hospital
Rainer Hoffmann, MD study chair
RWTH Aachen University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 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 9 Sep 2008. 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. 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?
Improvement in LV function and LV remodelling (time frame: 6 to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00748735, which also lists 3 linked publications.
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 9 Sep 2008.