Left Ventricular DysfunctionNCT01609738
Left Ventricular Septum Pacing in Patients by Transvenous Approach Through the Inter-ventricular Septum
An observational study of Left Ventricular Dysfunction and Cardiac Conduction Defect, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Cardiac pacing is the only effective treatment for symptomatic bradycardia. The right ventricular apex (RVA) has become the most frequently used ventricular pacing site. However, RVA pacing has been shown to cause left ventricular (LV) dyssynchrony wich can lead to LV dysfunction and development of heart failure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Left Ventricular Dysfunction, Cardiac Conduction Defect, Heart Failure
- What is being tested?
- Left ventricular septum pacing lead
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2012to Feb 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study subjects are recruited from patients referred to the out-patient pacemaker/ICD clinic of our hospital.
Who may be able to join
- Cardiac pacing indication for sinus node dysfunction (dual chamber pacemaker) or indication for CRT (BiV pacemaker).
- Patient with sinus node dysfunction:
- Normal left ventricular ejection fraction (LVEF > 50%)
- Left ventricular end-diastolic diameter (LVEDD) < 55mm
- QRS duration < 100ms
- Patient with CRT indication:
Show all 14Show fewer
- Non-ischemic cardiomyopathy
- LVEF is < 35%
- Typical left bundle-branch block on surface ECG
- QRS duration >150ms
- NYHA functional class I-III
- Greater than 18 years of age
- Stable sinus rhythm at the time of inclusion
- Willing and capable of giving informed consent
Who cannot join
- Ventricular pacing dependent
- High degree AV block
- Previous septal myocardial infarction
- Previously implanted pacing device
- Abnormal venous anatomy
- Left ventricular septum wall thickness >10mm determined by echocardiography
- Presence of severe valvular disease
- Presence of an ongoing progressive terminal disease associated with a reduced likelihood of survival for the duration of the study
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, Limburg, 6202 AZ
About this study
Official title: Left Ventricular Septum Pacing in Patients by Transvenous Approach Through the Inter-ventricular Septum - Feasibility, Long-term Lead Stability and Safety
Cardiac pacing is the only effective treatment for symptomatic bradycardia. The right ventricular apex (RVA) has become the most frequently used ventricular pacing site. However, RVA pacing has been shown to cause left ventricular (LV) dyssynchrony wich can lead to LV dysfunction and development of heart failure. Recent studies in animals have demonstrated that pacing at the LV septum induces significantly less ventricular dyssynchrony than RVA pacing and is able to improve LV function to a similar degree as biventricular (BiV) pacing. In addition it was shown that a LV septum lead can be placed permanently by driving a lead with extended helix from the RV side through the inter-ventricular septum into the LV endocardial layer. This was shown to be a feasible and safe procedure and lead stability was shown during four months of follow-up in otherwise healthy and active canines. LV septum pacing may therefore be a good treatment alternative in patients with symptomatic bradycardia, as well as patients with an indication for cardiac resynchronization therapy (CRT). The purpose of this study is to translate the findings from preclinical studies to the clinical situation by investigating the feasibility, long-term lead stability and safety of LV septum pacing by transvenous approach through the inter-ventricular septum in patients.
Read the detailed description
Cardiac pacing is the only effective treatment for symptomatic bradycardia. After the introduction of the implantable pacemaker (PM), the right ventricular apex (RVA) has become the most frequently used ventricular pacing site. However, clinical studies have shown that RVA pacing leads to left ventricular (LV) dyssynchrony, and on the long run to adverse structural changes (remodeling), a higher risk of developing atrial fibrillation and heart failure, and higher mortality.
Recognition of the adverse effects of RVA pacing has generated interest in alternative ventricular pacing sites. Recent studies in animals have shown that pacing at the LV septum induces significantly less ventricular dyssynchrony than RVA pacing. In addition it was shown that a LV septum lead can be placed permanently by introducing a custom lead with extended helix transvenously and, after positioning it against the RV septum, driving it through the inter-ventricular septum into the LV endocardial layer. This was shown to be a feasible and safe procedure and lead stability was shown during four months of follow-up in otherwise healthy and active canines.
Animal studies have also shown that LV septum pacing is able to improve LV function to a similar degree as simultaneous biventricular (BiV) pacing used in cardiac resynchronization therapy (CRT). CRT was introduced to restore the abnormal ventricular activation and contraction in patients with heart failure and intra-ventricular conduction delay. Large clinical trials have shown that CRT improves LV systolic pump function, reverses structural remodelling, improves quality of life and exercise tolerance, and decreases mortality. Unfortunately, problems encountered during positioning and fixation of the LV pacing lead in the coronary vein result in suboptimal or loss of CRT in at least a quarter of CRT candidates and require re-operation in 7% during follow up.
The adverse effects of RVA pacing, the limitations of BiV pacing and the promising effects of LV septum pacing in preclinical studies have led to the idea that LV septum pacing may be a good treatment alternative in patients with symptomatic bradycardia, as well as patients with an indication for CRT. In the latter category, CRT could then be performed using a single ventricular pacing lead, thus limiting the number of lead implantations, and thereby reducing complication rate and implantation costs as well as avoiding the difficult access route through the coronary vein.
It is the aim of this study to translate the findings from preclinical studies to the clinical situation by investigating the feasibility, long-term lead stability and safety of LV septum pacing by transvenous approach through the inter-ventricular septum in patients with a PM or CRT indication. The results may have a large impact on future pacing therapy. The LV septum may become the universal pacing site, being preferred for anti-bradycardia therapy, and being an equal alternative for BiV pacing, but easier to apply, less invasive and more cost-effective.
- Conditions
- Left Ventricular Dysfunction, Cardiac Conduction Defect, Heart Failure, Sick Sinus Syndrome
- Being tested
- Left ventricular septum pacing lead
- Keywords
- Cardiac pacing, Left ventricular septal pacing, Feasibility and safety, Lead stability, Hemodynamics, Left ventricular dyssynchrony, Pacing for heart failure, Cardiac resynchronization therapy
- Medical subject headings
- Ventricular Dysfunction, Left, Cardiac Conduction System Disease, Heart Failure, Sick Sinus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left ventricular septum pacing leadDevice
Also called Adapted Medtronic Select Secure 3830 pacing lead
A left ventricular septum pacing lead is permanently placed by introducing a custom lead with extended helix transvenously and, after positioning it against the RV septum, driving it through the inter-ventricular septum into the LV endocardial layer.
| Study group | Role | What they receive |
|---|---|---|
| Sinus node dysfunction | Patients with sinus node dysfunction and structurally normal hearts Receives: Device: Left ventricular septum pacing lead | |
| CRT indication | Patients with an indication for CRT (heart failure with an LVEF <35% and LBBB) Receives: Device: Left ventricular septum pacing lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of successful LV septum lead implantations
LV septum lead implantation is considered successful if the lead can be placed in the endocardial LV septum and adequate and stable sensing and pacing tresholds are achieved.
Measured: Baseline and 6 months
Change in sensing values, pacing threshold and lead impedance
Maintenance of stable lead function is determined by assessment of change in the electrical parameters: sensing value, pacing threshold and lead impedance at baseline versus 6 months follow-up.
Measured: Baseline and 6 months
Number of participants with procedure or lead related adverse events
The number of participant with and the kind of procedure- or lead related complications are assessed at the time of the procedure and up to 6 months after lead implantation. Special attention is given to the presence of perforation or rupture of the inter-ventricular septum or free wall, pericardial effusion, thrombosis, heart rhythm disturbances, conduction disturbances, and lead-/screw dislocation/-fracture.
Measured: Baseline and 6 months
Secondary outcomes (6)
Acute change in LVdP/dtmax
Acute change in LV systolic function using the hemodynamic parameter LVdP/dtmax during LV septum pacing compared to:
- RVA pacing and baseline (atrial pacing / AAI mode) in patients with SND.
- RVA pacing, single LV epicardial lateral wall pacing, Bi-LV pacing (LV septum and LV lateral wall pacing), BiV pacing (RV septum and LV lateral wall pacing) and baseline (atrial pacing / AAI mode) in heart failure patients who are candidates for CRT.
Measured: Acute measurements are performed for the duration of the lead implantation procedure, an expected average of two hours
Acute change in LV stroke volume
Acute change in LV systolic function using the hemodynamic parameter LV stroke volume measured by Nexfin, during LV septum pacing compared to:
- RVA pacing and baseline (atrial pacing / AAI mode) in patients with SND.
- RVA pacing, single LV epicardial lateral wall pacing, Bi-LV pacing (LV septum and LV lateral wall pacing), BiV pacing (RV septum and LV lateral wall pacing) and baseline (atrial pacing / AAI mode) in heart failure patients who are candidates for CRT.
Measured: Acute measurements are performed for the duration of the lead implantation procedure, an expected average of two hours
Acute change in QRS duration
Acute change in sequence of LV electrical activation using the electrocardiographic parameter QRS duration, during LV septum pacing compared to:
- RVA pacing and baseline (atrial pacing / AAI mode) in patients with SND.
- RVA pacing, single LV epicardial lateral wall pacing, Bi-LV pacing (LV septum and LV lateral wall pacing), BiV pacing (RV septum and LV lateral wall pacing) and baseline (atrial pacing / AAI mode) in heart failure patients who are candidates for CRT.
Measured: Baseline and 4 weeks
Acute change in 3-dimensional QRS vector direction
Acute change in sequence of LV electrical activation using the electrocardiographic parameter 3-dimensional QRS vector direction, during LV septum pacing compared to:
- RVA pacing and baseline (atrial pacing / AAI mode) in patients with SND.
- RVA pacing, single LV epicardial lateral wall pacing, Bi-LV pacing (LV septum and LV lateral wall pacing), BiV pacing (RV septum and LV lateral wall pacing) and baseline (atrial pacing / AAI mode) in heart failure patients who are candidates for CRT.
Measured: Baseline and 4 weeks
Acute change in SPECKLE-tracking strain
Acute change in regional myocardial deformation patterns using the echocardiographic parameter SPECKLE-tracking strain, during LV septum pacing compared to:
- RVA pacing and baseline (atrial pacing / AAI mode) in patients with SND.
- RVA pacing, single LV epicardial lateral wall pacing, Bi-LV pacing (LV septum and LV lateral wall pacing), BiV pacing (RV septum and LV lateral wall pacing) and baseline (atrial pacing / AAI mode) in heart failure patients who are candidates for CRT.
Measured: Baseline and 4 weeks
Difference between relative changes in LV stroke volume assessed by Nexfin and relative changes in invasively measured LVdp/dtmax.
Correlation between the relative change in non-invasively measured LV stroke volume using Nexfin and the relatieve change in invasively determined LV dP/dtmax, during LV septum pacing compared to:
- RVA pacing and baseline (atrial pacing / AAI mode) in patients with SND.
- RVA pacing, single LV epicardial lateral wall pacing, Bi-LV pacing (LV septum and LV lateral wall pacing), BiV pacing (RV septum and LV lateral wall pacing) and baseline (atrial pacing / AAI mode) in heart failure patients who are candidates for CRT.
Measured: Acute measurements are performed for the duration of the lead implantation procedure, an expected average of two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startNov 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular DysfunctionStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic Cardiac Rhythm and Heart Failure
- Responsible party
- Sponsor
- Investigators
- Frits Prinzen, PhD, Principal investigator, Maastricht UniversityKevin Vernooy, MD, PhD, Study director, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609738
- Sponsor's protocol ID
- NL37648.068.11
- Other IDs
- METC 11-1-047
- Status last verified
- Apr 2016
- First submitted
- 5 Apr 2012
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mills RW, Cornelussen RN, Mulligan LJ, Strik M, Rademakers LM, Skadsberg ND, van Hunnik A, Kuiper M, Lampert A, Delhaas T, Prinzen FW. Left ventricular septal and left ventricular apical pacing chronically maintain cardiac contractile coordination, pump function and efficiency. Circ Arrhythm Electrophysiol. 2009 Oct;2(5):571-9. doi: 10.1161/CIRCEP.109.882910. Epub 2009 Aug 25.
PubMed 19843926Peschar M, de Swart H, Michels KJ, Reneman RS, Prinzen FW. Left ventricular septal and apex pacing for optimal pump function in canine hearts. J Am Coll Cardiol. 2003 Apr 2;41(7):1218-26. doi: 10.1016/s0735-1097(03)00091-3.
PubMed 12679225Grosfeld MJ, Res JC, Vos DH, de Boer TJ, Bos HJ. Testing a new mechanism for left interventricular septal pacing: the transseptal route; a feasibility and safety study. Europace. 2002 Oct;4(4):439-44. doi: 10.1053/eupc.2002.0253.
PubMed 12408265Andersen HR, Nielsen JC, Thomsen PE, Thuesen L, Mortensen PT, Vesterlund T, Pedersen AK. Long-term follow-up of patients from a randomised trial of atrial versus ventricular pacing for sick-sinus syndrome. Lancet. 1997 Oct 25;350(9086):1210-6. doi: 10.1016/S0140-6736(97)03425-9.
PubMed 9652562Wilkoff BL, Cook JR, Epstein AE, Greene HL, Hallstrom AP, Hsia H, Kutalek SP, Sharma A; Dual Chamber and VVI Implantable Defibrillator Trial Investigators. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA. 2002 Dec 25;288(24):3115-23. doi: 10.1001/jama.288.24.3115.
PubMed 12495391Sweeney MO, Hellkamp AS, Ellenbogen KA, Greenspon AJ, Freedman RA, Lee KL, Lamas GA; MOde Selection Trial Investigators. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. 2003 Jun 17;107(23):2932-7. doi: 10.1161/01.CIR.0000072769.17295.B1. Epub 2003 Jun 2.
PubMed 12782566Lamas GA, Lee KL, Sweeney MO, Silverman R, Leon A, Yee R, Marinchak RA, Flaker G, Schron E, Orav EJ, Hellkamp AS, Greer S, McAnulty J, Ellenbogen K, Ehlert F, Freedman RA, Estes NA 3rd, Greenspon A, Goldman L; Mode Selection Trial in Sinus-Node Dysfunction. Ventricular pacing or dual-chamber pacing for sinus-node dysfunction. N Engl J Med. 2002 Jun 13;346(24):1854-62. doi: 10.1056/NEJMoa013040.
PubMed 12063369Steinberg JS, Fischer A, Wang P, Schuger C, Daubert J, McNitt S, Andrews M, Brown M, Hall WJ, Zareba W, Moss AJ; MADIT II Investigators. The clinical implications of cumulative right ventricular pacing in the multicenter automatic defibrillator trial II. J Cardiovasc Electrophysiol. 2005 Apr;16(4):359-65. doi: 10.1046/j.1540-8167.2005.50038.x.
PubMed 15828875Auricchio A, Stellbrink C, Block M, Sack S, Vogt J, Bakker P, Klein H, Kramer A, Ding J, Salo R, Tockman B, Pochet T, Spinelli J. Effect of pacing chamber and atrioventricular delay on acute systolic function of paced patients with congestive heart failure. The Pacing Therapies for Congestive Heart Failure Study Group. The Guidant Congestive Heart Failure Research Group. Circulation. 1999 Jun 15;99(23):2993-3001. doi: 10.1161/01.cir.99.23.2993.
PubMed 10368116Wecke L, Rubulis A, Lundahl G, Rosen MR, Bergfeldt L. Right ventricular pacing-induced electrophysiological remodeling in the human heart and its relationship to cardiac memory. Heart Rhythm. 2007 Dec;4(12):1477-86. doi: 10.1016/j.hrthm.2007.08.001. Epub 2007 Aug 11.
PubMed 17997360
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular Septum Pacing in Patients by Transvenous Approach Through the Inter-ventricular Septum - Feasibility, Long-term Lead Stability and Safety
- ClinicalTrials.gov ID
- NCT01609738
- Acronym / sponsor ID
- NL37648.068.11
- Conditions
- Left Ventricular Dysfunction, Cardiac Conduction Defect, Heart Failure, Sick Sinus Syndrome
- Keywords
- Cardiac pacing, Left ventricular septal pacing, Feasibility and safety, Lead stability, Hemodynamics, Left ventricular dyssynchrony, Pacing for heart failure, Cardiac resynchronization therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Medtronic Cardiac Rhythm and Heart Failure
- Study start
- Nov 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 1 Jun 2012 (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.
Cardiac pacing is the only effective treatment for symptomatic bradycardia. The right ventricular apex (RVA) has become the most frequently used ventricular pacing site. However, RVA pacing has been shown to cause left ventricular (LV) dyssynchrony wich can lead to LV dysfunction and development of heart failure. Recent studies in animals have demonstrated that pacing at the LV septum induces significantly less ventricular dyssynchrony than RVA pacing and is able to improve LV function to a similar degree as biventricular (BiV) pacing. In addition it was shown that a LV septum lead can be placed permanently by driving a lead with extended helix from the RV side through the inter-ventricular septum into the LV endocardial layer. This was shown to be a feasible and safe procedure and lead stability was shown during four months of follow-up in otherwise healthy and active canines. LV septum pacing may therefore be a good treatment alternative in patients with symptomatic bradycardia, as well as patients with an indication for cardiac resynchronization therapy (CRT). The purpose of this study is to translate the findings from preclinical studies to the clinical situation by investigating the feasibility, long-term lead stability and safety of LV septum pacing by transvenous approach through the inter-ventricular septum in patients.
Detailed description
Cardiac pacing is the only effective treatment for symptomatic bradycardia. After the introduction of the implantable pacemaker (PM), the right ventricular apex (RVA) has become the most frequently used ventricular pacing site. However, clinical studies have shown that RVA pacing leads to left ventricular (LV) dyssynchrony, and on the long run to adverse structural changes (remodeling), a higher risk of developing atrial fibrillation and heart failure, and higher mortality.
Recognition of the adverse effects of RVA pacing has generated interest in alternative ventricular pacing sites. Recent studies in animals have shown that pacing at the LV septum induces significantly less ventricular dyssynchrony than RVA pacing. In addition it was shown that a LV septum lead can be placed permanently by introducing a custom lead with extended helix transvenously and, after positioning it against the RV septum, driving it through the inter-ventricular septum into the LV endocardial layer. This was shown to be a feasible and safe procedure and lead stability was shown during four months of follow-up in otherwise healthy and active canines.
Animal studies have also shown that LV septum pacing is able to improve LV function to a similar degree as simultaneous biventricular (BiV) pacing used in cardiac resynchronization therapy (CRT). CRT was introduced to restore the abnormal ventricular activation and contraction in patients with heart failure and intra-ventricular conduction delay. Large clinical trials have shown that CRT improves LV systolic pump function, reverses structural remodelling, improves quality of life and exercise tolerance, and decreases mortality. Unfortunately, problems encountered during positioning and fixation of the LV pacing lead in the coronary vein result in suboptimal or loss of CRT in at least a quarter of CRT candidates and require re-operation in 7% during follow up.
The adverse effects of RVA pacing, the limitations of BiV pacing and the promising effects of LV septum pacing in preclinical studies have led to the idea that LV septum pacing may be a good treatment alternative in patients with symptomatic bradycardia, as well as patients with an indication for CRT. In the latter category, CRT could then be performed using a single ventricular pacing lead, thus limiting the number of lead implantations, and thereby reducing complication rate and implantation costs as well as avoiding the difficult access route through the coronary vein.
It is the aim of this study to translate the findings from preclinical studies to the clinical situation by investigating the feasibility, long-term lead stability and safety of LV septum pacing by transvenous approach through the inter-ventricular septum in patients with a PM or CRT indication. The results may have a large impact on future pacing therapy. The LV septum may become the universal pacing site, being preferred for anti-bradycardia therapy, and being an equal alternative for BiV pacing, but easier to apply, less invasive and more cost-effective.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sinus node dysfunction | – | Device: Left ventricular septum pacing leadPatients with sinus node dysfunction and structurally normal hearts |
| CRT indication | – | Device: Left ventricular septum pacing leadPatients with an indication for CRT (heart failure with an LVEF <35% and LBBB) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study subjects are recruited from patients referred to the out-patient pacemaker/ICD clinic of our hospital.
Key inclusion criteria (14 listed)
- Cardiac pacing indication for sinus node dysfunction (dual chamber pacemaker) or indication for CRT (BiV pacemaker).
- Greater than 18 years of age
- Stable sinus rhythm at the time of inclusion
- Willing and capable of giving informed consent
Key exclusion criteria (8 listed)
- Ventricular pacing dependent
- High degree AV block
- Previous septal myocardial infarction
- Previously implanted pacing device
- Abnormal venous anatomy
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 |
|---|---|---|
| Left ventricular septum pacing leadAlso: Adapted Medtronic Select Secure 3830 pacing leadA left ventricular septum pacing lead is permanently placed by introducing a custom lead with extended helix transvenously and, after positioning it against the RV septum, driving it through the inter-ventricular septum into the LV endocardial layer. | Device | CRT indication, Sinus node dysfunction |
Primary outcome
Number of successful LV septum lead implantations
Time frame: Baseline and 6 months
LV septum lead implantation is considered successful if the lead can be placed in the endocardial LV septum and adequate and stable sensing and pacing tresholds are achieved.
Change in sensing values, pacing threshold and lead impedance
Time frame: Baseline and 6 months
Maintenance of stable lead function is determined by assessment of change in the electrical parameters: sensing value, pacing threshold and lead impedance at baseline versus 6 months follow-up.
Number of participants with procedure or lead related adverse events
Time frame: Baseline and 6 months
The number of participant with and the kind of procedure- or lead related complications are assessed at the time of the procedure and up to 6 months after lead implantation. Special attention is given to the presence of perforation or rupture of the inter-ventricular septum or free wall, pericardial effusion, thrombosis, heart rhythm disturbances, conduction disturbances, and lead-/screw dislocation/-fracture.
6 secondary outcomes
Acute change in LVdP/dtmax
Time frame: Acute measurements are performed for the duration of the lead implantation procedure, an expected average of two hours
Acute change in LV stroke volume
Time frame: Acute measurements are performed for the duration of the lead implantation procedure, an expected average of two hours
Acute change in QRS duration
Time frame: Baseline and 4 weeks
Acute change in 3-dimensional QRS vector direction
Time frame: Baseline and 4 weeks
Acute change in SPECKLE-tracking strain
Time frame: Baseline and 4 weeks
Difference between relative changes in LV stroke volume assessed by Nexfin and relative changes in invasively measured LVdp/dtmax.
Time frame: Acute measurements are performed for the duration of the lead implantation procedure, an expected average of two hours
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 8 Apr 2016.
- Background: PubMed 19843926Mills RW, Cornelussen RN, Mulligan LJ, Strik M, Rademakers LM, Skadsberg ND, van Hunnik A, Kuiper M, Lampert A, Delhaas T, Prinzen FW. Left ventricular septal and left ventricular apical pacing chronically maintain cardiac contractile coordination, pump function and efficiency. Circ Arrhythm Electrophysiol. 2009 Oct;2(5):571-9. doi: 10.1161/CIRCEP.109.882910. Epub 2009 Aug 25.
- Background: PubMed 12679225Peschar M, de Swart H, Michels KJ, Reneman RS, Prinzen FW. Left ventricular septal and apex pacing for optimal pump function in canine hearts. J Am Coll Cardiol. 2003 Apr 2;41(7):1218-26. doi: 10.1016/s0735-1097(03)00091-3.
- Background: PubMed 12408265Grosfeld MJ, Res JC, Vos DH, de Boer TJ, Bos HJ. Testing a new mechanism for left interventricular septal pacing: the transseptal route; a feasibility and safety study. Europace. 2002 Oct;4(4):439-44. doi: 10.1053/eupc.2002.0253.
- Background: PubMed 9652562Andersen HR, Nielsen JC, Thomsen PE, Thuesen L, Mortensen PT, Vesterlund T, Pedersen AK. Long-term follow-up of patients from a randomised trial of atrial versus ventricular pacing for sick-sinus syndrome. Lancet. 1997 Oct 25;350(9086):1210-6. doi: 10.1016/S0140-6736(97)03425-9.
- Background: PubMed 12495391Wilkoff BL, Cook JR, Epstein AE, Greene HL, Hallstrom AP, Hsia H, Kutalek SP, Sharma A; Dual Chamber and VVI Implantable Defibrillator Trial Investigators. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA. 2002 Dec 25;288(24):3115-23. doi: 10.1001/jama.288.24.3115.
- Background: PubMed 12782566Sweeney MO, Hellkamp AS, Ellenbogen KA, Greenspon AJ, Freedman RA, Lee KL, Lamas GA; MOde Selection Trial Investigators. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. 2003 Jun 17;107(23):2932-7. doi: 10.1161/01.CIR.0000072769.17295.B1. Epub 2003 Jun 2.
- Background: PubMed 12063369Lamas GA, Lee KL, Sweeney MO, Silverman R, Leon A, Yee R, Marinchak RA, Flaker G, Schron E, Orav EJ, Hellkamp AS, Greer S, McAnulty J, Ellenbogen K, Ehlert F, Freedman RA, Estes NA 3rd, Greenspon A, Goldman L; Mode Selection Trial in Sinus-Node Dysfunction. Ventricular pacing or dual-chamber pacing for sinus-node dysfunction. N Engl J Med. 2002 Jun 13;346(24):1854-62. doi: 10.1056/NEJMoa013040.
- Background: PubMed 15828875Steinberg JS, Fischer A, Wang P, Schuger C, Daubert J, McNitt S, Andrews M, Brown M, Hall WJ, Zareba W, Moss AJ; MADIT II Investigators. The clinical implications of cumulative right ventricular pacing in the multicenter automatic defibrillator trial II. J Cardiovasc Electrophysiol. 2005 Apr;16(4):359-65. doi: 10.1046/j.1540-8167.2005.50038.x.
- Background: PubMed 10368116Auricchio A, Stellbrink C, Block M, Sack S, Vogt J, Bakker P, Klein H, Kramer A, Ding J, Salo R, Tockman B, Pochet T, Spinelli J. Effect of pacing chamber and atrioventricular delay on acute systolic function of paced patients with congestive heart failure. The Pacing Therapies for Congestive Heart Failure Study Group. The Guidant Congestive Heart Failure Research Group. Circulation. 1999 Jun 15;99(23):2993-3001. doi: 10.1161/01.cir.99.23.2993.
- Background: PubMed 17997360Wecke L, Rubulis A, Lundahl G, Rosen MR, Bergfeldt L. Right ventricular pacing-induced electrophysiological remodeling in the human heart and its relationship to cardiac memory. Heart Rhythm. 2007 Dec;4(12):1477-86. doi: 10.1016/j.hrthm.2007.08.001. Epub 2007 Aug 11.
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Tako Tsubo Cardiomyopathy, Microvascular Dysfunction
Not yet recruiting
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
Valvular Heart Disease Patients, Aortic Stenosis
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.
Frits Prinzen, PhD principal investigator
Maastricht University
Kevin Vernooy, MD, PhD study director
Maastricht University Medical Centre
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 Left Ventricular Dysfunction and Cardiac Conduction Defect, run by Maastricht University Medical Center at 1 site in Netherlands.
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 14 inclusion and 8 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 8 Apr 2016. 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 Netherlands. 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?
Number of successful LV septum lead implantations (time frame: Baseline and 6 months). The study lists 3 primary outcomes in all. 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 NCT01609738, which also lists 10 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 8 Apr 2016.