Heart FailureNCT03415945
Left Ventricular Septal Pacing: Potential Application for Cardiac Resynchronization Therapy
A study testing Cardiac resynchronization therapy (CRT) in people with Heart Failure and Cardiac Resynchronization Therapy, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
In cardiac resynchronization therapy (CRT), biventricular pacing is performed by pacing the right ventricle (RV) and epicardium of the left ventricular (LV) postero-lateral wall. A significant proportion of apparently suitable patients fail to benefit from CRT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiac Resynchronization Therapy, Left Bundle-Branch Block
- What is being tested?
- Cardiac resynchronization therapy (CRT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Nov 2017to 23 May 2020
- 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
- Chronic heart failure with NYHA functional class II-IV
- Left ventricular ejection fraction (LVEF) < 35%
- LBBB and QRS duration ≥ 130 ms or non-LBBB and QRS duration ≥ 150 ms
- In sinus rhythm
- Optimal pharmacological therapy
Who cannot join
- Persistent atrial fibrillation
- ≥ 2 premature ventricular complexes on standard 12-lead electrocardiogram (ECG)
- Age < 18 years
- Incapable of giving informed consent
- Moderate to severe aortic valve stenosis
- Peripheral vascular disease
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg, 6229 HX
Floor Salden, MD, +31-43-3884520, floor.salden@mumc.nl
Frits Prinzen, PhD
About this study
In cardiac resynchronization therapy (CRT), biventricular pacing is performed by pacing the right ventricle (RV) and epicardium of the left ventricular (LV) postero-lateral wall. A significant proportion of apparently suitable patients fail to benefit from CRT. One of the problems of CRT is proper positioning and fixation of the LV pacing lead in the coronary vein. LV septal pacing may be a good alternative for BiV pacing in patients with an indication for CRT.
Read the detailed description
Cardiac pump function depends on physiological electrical activation of the ventricles. This normal activation is disturbed during artificial electrical stimulation (pacing) of the right ventricle (RV), the common therapy to treat symptomatic slow heart rate ("rate control"), as well as during electrical dyssynchrony such as left bundle branch block (LBBB). As a consequence, RV pacing and LBBB reduce cardiac pump function and increase cardiac morbidity and mortality. During the last two decades cardiac resynchronization therapy (CRT) has emerged as treatment to "resynchronize" ventricular electrical activation by pacing the RV apical septum and left ventricular (LV) postero-lateral wall simultaneously ("biventricular" (BiV) pacing).
Since initial approval of the therapy over 10 years ago, there have been hundreds of thousands of implants performed worldwide. In the Netherlands currently more than 2000 CRT devices are implanted each year. Large clinical trials have shown that CRT improves LV systolic pump function, reverses structural remodelling, improves quality of life and exercise tolerance, and decrease mortality. However, a significant proportion of apparently suitable patients fail to benefit. Depending on the definition used, the response to CRT is positive in 50-70% of treated patients, leaving 30-50% without significant effect. One of the problems of CRT is proper positioning and fixation of the LV pacing lead in the coronary vein.
Research in the laboratory of the the investigators revealed that in dogs with AV-block and in patients with sinus node disease, pacing at the LV endocardial side of the interventricular septum (LV septal pacing) provides near physiological ventricular activation, near uniform distribution of workload, and near normal pump function. Furthermore, pump function during LV septal pacing was at least as good as during BiV pacing. A recent study, with acute hemodynamic data in dogs with LBBB and in a small group of patients with LBBB, further indicates that LV septal pacing may be used for CRT. A weakness of the patient data is that these patients were either non-responders to conventional CRT or patients where no access to the coronary sinus was obtained. Therefore, this group may not be representative for the entire CRT candidate population.
Two factors appear to determine the positive effect of LV septal pacing: the slow impulse conduction across the interventricular septum and the fast impulse conduction along the inner layers of the LV wall through superficial, non-Purkinje fibers. Following this reasoning, the investigators expect that the exact pacing site at the septum is not critical. This would be of great advantage for future applications in patients, since proper implantation of an LV lead in the coronary sinus requires attention in order to position the lead in the latest activated region.
The aim of the present study is to compare the electrophysiological and hemodynamic effects of several modes and sites of LV septal pacing with those of BiV pacing in patients undergoing CRT device implantation. The results may have a large impact on future pacing therapy. The LV septum may become an alternative for BiV pacing, but easier to apply, less invasive, and more cost-effective.
- Being tested
- Cardiac resynchronization therapy (CRT)
- Medical subject headings
- Heart Failure, Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac resynchronization therapy (CRT)Device
All study participants have a clinical indication for CRT and will receive CRT implantation as part of their routine medical care. Additionally, participants will receive temporary left and right ventricular septal pacing electrodes and a temporary PressureWire to investigate the acute hemodynamic effect of left ventricular septal pacing, using patients as their own controls.
| Study group | Role | What they receive |
|---|---|---|
| CRT implantation | Experimental | In cardiac resynchronization therapy (CRT), biventricular pacing is performed by pacing the right ventricle (RV) and epicardium of the left ventricular (LV) posterolateral wall. Receives: Device: Cardiac resynchronization therapy (CRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute hemodynamic effect (LV dP/dtmax) of the best LV septal pacing side and conventional BiV pacing.
A RadiAnalyzer Physio monitor version 2.02 (St. Jude Medical, St. Paul, USA) is used to calculate LV dP/dtmax as a measure of LV systolic function.
Measured: The outcome measure will be assessed during the CRT implantation procedure (the total procedure time will increase 45 to 60 minutes).
Secondary outcomes (2)
Acute hemodynamic effects (LV dP/dtmax) of the different LV septal pacing sides with RV apical septum pacing, His pacing, RV septum pacing, LV epicardial postero-lateral wall pacing and intrinsic ventricular activation.
A RadiAnalyzer Physio monitor version 2.02 (St. Jude Medical, St. Paul, USA) is used to calculate LV dP/dtmax as a measure of LV systolic function.
Measured: The outcome measure will be assessed during the CRT implantation procedure (the total procedure time will increase 45 to 60 minutes).
The effect on the sequence of LV electrical activation and body surface electrocardiographic mapping
The sequence of LV electrical activation will be assessed by 3-dimensional vectorcardiography (VCG) and non-invasive body surface electrocardiographic mapping using the Verathon Heartscape system (developed by Medtronic)
Measured: The outcome measure will be assessed during the CRT implantation procedure (the total procedure time will increase 45 to 60 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start23 Nov 2017
- Primary completion23 May 2019 (estimated)
- Study completion23 May 2020 (estimated)
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Vernooy, MD, PhD, Principal investigator, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415945
- Sponsor's protocol ID
- NL58809.068.16
- Status last verified
- Feb 2018
- First submitted
- 23 Jan 2017
- Last updated
- 12 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L; Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005 Apr 14;352(15):1539-49. doi: 10.1056/NEJMoa050496. Epub 2005 Mar 7.
PubMed 15753115Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J; MIRACLE Study Group. Multicenter InSync Randomized Clinical Evaluation. Cardiac resynchronization in chronic heart failure. N Engl J Med. 2002 Jun 13;346(24):1845-53. doi: 10.1056/NEJMoa013168.
PubMed 12063368Mills 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 19843926Mafi-Rad M, Luermans JG, Blaauw Y, Janssen M, Crijns HJ, Prinzen FW, Vernooy K. Feasibility and Acute Hemodynamic Effect of Left Ventricular Septal Pacing by Transvenous Approach Through the Interventricular Septum. Circ Arrhythm Electrophysiol. 2016 Mar;9(3):e003344. doi: 10.1161/CIRCEP.115.003344.
PubMed 26888445Strik M, Rademakers LM, van Deursen CJ, van Hunnik A, Kuiper M, Klersy C, Auricchio A, Prinzen FW. Endocardial left ventricular pacing improves cardiac resynchronization therapy in chronic asynchronous infarction and heart failure models. Circ Arrhythm Electrophysiol. 2012 Feb;5(1):191-200. doi: 10.1161/CIRCEP.111.965814. Epub 2011 Nov 7.
PubMed 22062796Strik M, van Deursen CJ, van Middendorp LB, van Hunnik A, Kuiper M, Auricchio A, Prinzen FW. Transseptal conduction as an important determinant for cardiac resynchronization therapy, as revealed by extensive electrical mapping in the dyssynchronous canine heart. Circ Arrhythm Electrophysiol. 2013 Aug;6(4):682-9. doi: 10.1161/CIRCEP.111.000028. Epub 2013 Jul 19.
PubMed 23873141Singh JP, Fan D, Heist EK, Alabiad CR, Taub C, Reddy V, Mansour M, Picard MH, Ruskin JN, Mela T. Left ventricular lead electrical delay predicts response to cardiac resynchronization therapy. Heart Rhythm. 2006 Nov;3(11):1285-92. doi: 10.1016/j.hrthm.2006.07.034. Epub 2006 Aug 10.
PubMed 17074633Kors JA, van Herpen G, Sittig AC, van Bemmel JH. Reconstruction of the Frank vectorcardiogram from standard electrocardiographic leads: diagnostic comparison of different methods. Eur Heart J. 1990 Dec;11(12):1083-92. doi: 10.1093/oxfordjournals.eurheartj.a059647.
PubMed 2292255Man S, Algra AM, Schreurs CA, Borleffs CJ, Scherptong RW, van Erven L, van der Wall EE, Cannegieter SC, Schalij MJ, Swenne CA. Influence of the vectorcardiogram synthesis matrix on the power of the electrocardiogram-derived spatial QRS-T angle to predict arrhythmias in patients with ischemic heart disease and systolic left ventricular dysfunction. J Electrocardiol. 2011 Jul-Aug;44(4):410-5. doi: 10.1016/j.jelectrocard.2011.04.007.
PubMed 21704219Schreurs CA, Algra AM, Man SC, Cannegieter SC, van der Wall EE, Schalij MJ, Kors JA, Swenne CA. The spatial QRS-T angle in the Frank vectorcardiogram: accuracy of estimates derived from the 12-lead electrocardiogram. J Electrocardiol. 2010 Jul-Aug;43(4):294-301. doi: 10.1016/j.jelectrocard.2010.03.009. Epub 2010 Apr 24.
PubMed 20417936
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular Septal Pacing: Potential Application for Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT03415945
- Acronym / sponsor ID
- NL58809.068.16
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 23 Nov 2017 (actual)
- Primary completion
- 23 May 2019 (estimated)
- Study completion
- 23 May 2020 (estimated)
- First posted
- 30 Jan 2018 (actual)
- 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 cardiac resynchronization therapy (CRT), biventricular pacing is performed by pacing the right ventricle (RV) and epicardium of the left ventricular (LV) postero-lateral wall. A significant proportion of apparently suitable patients fail to benefit from CRT. One of the problems of CRT is proper positioning and fixation of the LV pacing lead in the coronary vein. LV septal pacing may be a good alternative for BiV pacing in patients with an indication for CRT.
Detailed description
Cardiac pump function depends on physiological electrical activation of the ventricles. This normal activation is disturbed during artificial electrical stimulation (pacing) of the right ventricle (RV), the common therapy to treat symptomatic slow heart rate ("rate control"), as well as during electrical dyssynchrony such as left bundle branch block (LBBB). As a consequence, RV pacing and LBBB reduce cardiac pump function and increase cardiac morbidity and mortality. During the last two decades cardiac resynchronization therapy (CRT) has emerged as treatment to "resynchronize" ventricular electrical activation by pacing the RV apical septum and left ventricular (LV) postero-lateral wall simultaneously ("biventricular" (BiV) pacing).
Since initial approval of the therapy over 10 years ago, there have been hundreds of thousands of implants performed worldwide. In the Netherlands currently more than 2000 CRT devices are implanted each year. Large clinical trials have shown that CRT improves LV systolic pump function, reverses structural remodelling, improves quality of life and exercise tolerance, and decrease mortality. However, a significant proportion of apparently suitable patients fail to benefit. Depending on the definition used, the response to CRT is positive in 50-70% of treated patients, leaving 30-50% without significant effect. One of the problems of CRT is proper positioning and fixation of the LV pacing lead in the coronary vein.
Research in the laboratory of the the investigators revealed that in dogs with AV-block and in patients with sinus node disease, pacing at the LV endocardial side of the interventricular septum (LV septal pacing) provides near physiological ventricular activation, near uniform distribution of workload, and near normal pump function. Furthermore, pump function during LV septal pacing was at least as good as during BiV pacing. A recent study, with acute hemodynamic data in dogs with LBBB and in a small group of patients with LBBB, further indicates that LV septal pacing may be used for CRT. A weakness of the patient data is that these patients were either non-responders to conventional CRT or patients where no access to the coronary sinus was obtained. Therefore, this group may not be representative for the entire CRT candidate population.
Two factors appear to determine the positive effect of LV septal pacing: the slow impulse conduction across the interventricular septum and the fast impulse conduction along the inner layers of the LV wall through superficial, non-Purkinje fibers. Following this reasoning, the investigators expect that the exact pacing site at the septum is not critical. This would be of great advantage for future applications in patients, since proper implantation of an LV lead in the coronary sinus requires attention in order to position the lead in the latest activated region.
The aim of the present study is to compare the electrophysiological and hemodynamic effects of several modes and sites of LV septal pacing with those of BiV pacing in patients undergoing CRT device implantation. The results may have a large impact on future pacing therapy. The LV septum may become an alternative for BiV pacing, but easier to apply, less invasive, and more cost-effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRT implantation | Experimental | Device: Cardiac resynchronization therapy (CRT)In cardiac resynchronization therapy (CRT), biventricular pacing is performed by pacing the right ventricle (RV) and epicardium of the left ventricular (LV) posterolateral wall. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic heart failure with NYHA functional class II-IV
- Left ventricular ejection fraction (LVEF) < 35%
- LBBB and QRS duration ≥ 130 ms or non-LBBB and QRS duration ≥ 150 ms
- In sinus rhythm
- Optimal pharmacological therapy
Key exclusion criteria (6 listed)
- Persistent atrial fibrillation
- ≥ 2 premature ventricular complexes on standard 12-lead electrocardiogram (ECG)
- Age < 18 years
- Incapable of giving informed consent
- Moderate to severe aortic valve stenosis
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 |
|---|---|---|
| Cardiac resynchronization therapy (CRT)All study participants have a clinical indication for CRT and will receive CRT implantation as part of their routine medical care. Additionally, participants will receive temporary left and right ventricular septal pacing electrodes and a temporary PressureWire to investigate the acute hemodynamic effect of left ventricular septal pacing, using patients as their own controls. | Device | CRT implantation |
Primary outcome
Acute hemodynamic effect (LV dP/dtmax) of the best LV septal pacing side and conventional BiV pacing.
Time frame: The outcome measure will be assessed during the CRT implantation procedure (the total procedure time will increase 45 to 60 minutes).
A RadiAnalyzer Physio monitor version 2.02 (St. Jude Medical, St. Paul, USA) is used to calculate LV dP/dtmax as a measure of LV systolic function.
2 secondary outcomes
Acute hemodynamic effects (LV dP/dtmax) of the different LV septal pacing sides with RV apical septum pacing, His pacing, RV septum pacing, LV epicardial postero-lateral wall pacing and intrinsic ventricular activation.
Time frame: The outcome measure will be assessed during the CRT implantation procedure (the total procedure time will increase 45 to 60 minutes).
The effect on the sequence of LV electrical activation and body surface electrocardiographic mapping
Time frame: The outcome measure will be assessed during the CRT implantation procedure (the total procedure time will increase 45 to 60 minutes).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
- Background: PubMed 15753115Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L; Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005 Apr 14;352(15):1539-49. doi: 10.1056/NEJMoa050496. Epub 2005 Mar 7.
- Background: PubMed 12063368Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J; MIRACLE Study Group. Multicenter InSync Randomized Clinical Evaluation. Cardiac resynchronization in chronic heart failure. N Engl J Med. 2002 Jun 13;346(24):1845-53. doi: 10.1056/NEJMoa013168.
- 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 26888445Mafi-Rad M, Luermans JG, Blaauw Y, Janssen M, Crijns HJ, Prinzen FW, Vernooy K. Feasibility and Acute Hemodynamic Effect of Left Ventricular Septal Pacing by Transvenous Approach Through the Interventricular Septum. Circ Arrhythm Electrophysiol. 2016 Mar;9(3):e003344. doi: 10.1161/CIRCEP.115.003344.
- Background: PubMed 22062796Strik M, Rademakers LM, van Deursen CJ, van Hunnik A, Kuiper M, Klersy C, Auricchio A, Prinzen FW. Endocardial left ventricular pacing improves cardiac resynchronization therapy in chronic asynchronous infarction and heart failure models. Circ Arrhythm Electrophysiol. 2012 Feb;5(1):191-200. doi: 10.1161/CIRCEP.111.965814. Epub 2011 Nov 7.
- Background: PubMed 23873141Strik M, van Deursen CJ, van Middendorp LB, van Hunnik A, Kuiper M, Auricchio A, Prinzen FW. Transseptal conduction as an important determinant for cardiac resynchronization therapy, as revealed by extensive electrical mapping in the dyssynchronous canine heart. Circ Arrhythm Electrophysiol. 2013 Aug;6(4):682-9. doi: 10.1161/CIRCEP.111.000028. Epub 2013 Jul 19.
- Background: PubMed 17074633Singh JP, Fan D, Heist EK, Alabiad CR, Taub C, Reddy V, Mansour M, Picard MH, Ruskin JN, Mela T. Left ventricular lead electrical delay predicts response to cardiac resynchronization therapy. Heart Rhythm. 2006 Nov;3(11):1285-92. doi: 10.1016/j.hrthm.2006.07.034. Epub 2006 Aug 10.
- Background: PubMed 2292255Kors JA, van Herpen G, Sittig AC, van Bemmel JH. Reconstruction of the Frank vectorcardiogram from standard electrocardiographic leads: diagnostic comparison of different methods. Eur Heart J. 1990 Dec;11(12):1083-92. doi: 10.1093/oxfordjournals.eurheartj.a059647.
- Background: PubMed 21704219Man S, Algra AM, Schreurs CA, Borleffs CJ, Scherptong RW, van Erven L, van der Wall EE, Cannegieter SC, Schalij MJ, Swenne CA. Influence of the vectorcardiogram synthesis matrix on the power of the electrocardiogram-derived spatial QRS-T angle to predict arrhythmias in patients with ischemic heart disease and systolic left ventricular dysfunction. J Electrocardiol. 2011 Jul-Aug;44(4):410-5. doi: 10.1016/j.jelectrocard.2011.04.007.
- Background: PubMed 20417936Schreurs CA, Algra AM, Man SC, Cannegieter SC, van der Wall EE, Schalij MJ, Kors JA, Swenne CA. The spatial QRS-T angle in the Frank vectorcardiogram: accuracy of estimates derived from the 12-lead electrocardiogram. J Electrocardiol. 2010 Jul-Aug;43(4):294-301. doi: 10.1016/j.jelectrocard.2010.03.009. Epub 2010 Apr 24.
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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.
Kevin Vernooy, MD, PhD principal investigator
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?
A study testing Cardiac resynchronization therapy (CRT) in people with Heart Failure and Cardiac Resynchronization Therapy, 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Feb 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Floor Salden, MD (+31-43-3884520, floor.salden@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute hemodynamic effect (LV dP/dtmax) of the best LV septal pacing side and conventional BiV pacing. (time frame: The outcome measure will be assessed during the CRT implantation procedure (the total procedure time will increase 45 to 60 minutes).). 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 NCT03415945, 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 12 Feb 2018.