Heart FailureNCT02326493
Tailor-CRT: Better Application of Cardiac Resynchronization Therapy
A study testing Cardiac Resynchronization Therapy in people with Heart Failure and Left Bundle-Branch Block, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Approximately one third of patients treated with cardiac resynchronization therapy (CRT) do not derive any clinical benefit. CRT response can be improved by tailoring LV lead placement and programming of atrio-ventricular (AV) and inter-ventricular (VV) stimulation intervals to the individual patient. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure, Left Bundle-Branch Block
- What is being tested?
- Cardiac Resynchronization Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2014to Nov 2016
- 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 to 80 years
- 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%
- Left bundle-branch block (LBBB) with QRS duration > 120 ms
- In sinus rhythm
Who cannot join
- Atrial fibrillation
- ≥4 premature ventricular complexes on standard 12-lead ECG
- Age <18 years or > 80 years
- Incapable of giving informed consent
- Moderate to severe aortic valve stenosis
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, Limburg, 6202 AZ
About this study
Official title: Tailor-CRT: Better Application of Cardiac Resynchronization Therapy by Automated and Improved Selection of Location and Timing of Stimulation
Approximately one third of patients treated with cardiac resynchronization therapy (CRT) do not derive any clinical benefit. CRT response can be improved by tailoring LV lead placement and programming of atrio-ventricular (AV) and inter-ventricular (VV) stimulation intervals to the individual patient. However, the best strategy to optimize lead positioning and device programming still remains to be established. Earlier work in our research group suggests that the vector cardiogram (VCG) can be used to determine the optimal LV lead position and AV- and VV-intervals, and pilot studies showed the feasibility to derive a VCG-like signal (D-VCG) from the implanted pacing electrodes. Other studies have suggested that the best position for the LV electrode is the region of latest electrical activation. The region of latest electrical activation can be identified by measuring the electrical delay on the LV lead (LVLED) during implantation. The objective of this study is to investigate whether D-VCG can be used to determine the optimal AV- and VV-interval and whether VCG and LVLED can be used to determine the optimal LV lead position.
Read the detailed description
Cardiac resynchronization therapy (CRT) is an established treatment for heart failure (HF) patients with severe left ventricular (LV) systolic impairment and delayed electrical impulse conduction through the ventricles, such as left bundle-branch block (LBBB). Since initial approval of the therapy over 10 years ago, there have been hundreds of thousands of implants worldwide. In The Netherlands, currently more than 2000 CRT devices are implanted each year. In a heart with LBBB, electrical activation of the lateral LV free wall is delayed, which leads to dyssynchronous and inefficient LV mechanical contraction and compromised LV pump function. The positive impact of CRT on LV pump function is attributed to paced pre-excitation of the delayed activated lateral LV wall. CRT is most commonly applied by pacing the right ventricle (RV) and LV lateral wall (almost) simultaneously. This corrects the abnormal LV electrical activation and resynchronizes LV mechanical contraction, which in turn results in improved LV pump function.
Despite the striking effectiveness of CRT, 30-50% of apparently suitable patients show little or no improvement. Previous studies have shown that the response to CRT can be improved by tailoring LV lead placement and programming of atrioventricular (AV) and inter-ventricular (VV) stimulation intervals to the individual patient. In clinical practice, echocardiographic techniques are the most widely employed for CRT optimization. However these techniques are subject to large measurement errors and inter- and intra-observer variability. A more accurate technique is invasive assessment of acute hemodynamic response to CRT, with the most widely used invasive hemodynamic parameter being the maximum rate of LV systolic pressure rise (LVdP/dtmax). However, the invasive and time-consuming nature of this approach limits its use in clinical practice. Thus, the best strategy to optimize lead positioning and device programming still remains to be established.
Earlier work in our research group suggests that the vectorcardiogram (VCG) can be used to determine the optimal LV lead position and AV- and VV-intervals, and pilot studies showed the feasibility to derive a VCG-like signal (D-VCG) from the implanted pacing electrodes. Other studies have suggested that the best position for the LV electrode is the region of latest electrical activation. The region of latest electrical activation can be identified by measuring the electrical delay on the LV lead (LVLED) during implantation. Validation of these techniques for tailoring LV lead positioning and AV- and VV- stimulation intervals to the individual patient, will provide non-invasive and easy methods to optimize CRT application and improve response rate.
The objective of this study is to investigate whether D-VCG can be used to determine the optimal AV- and VV-interval and whether VCG and LVLED can be used to determine the optimal LV lead position. Validation of these techniques for tailoring LV lead positioning and AV- and VV- stimulation intervals to the individual patient, will provide non-invasive and easy methods to optimize CRT application and improve response rate.
- Conditions
- Heart Failure, Left Bundle-Branch Block
- Being tested
- Cardiac Resynchronization Therapy
- Keywords
- Cardiac Resynchronization Therapy, LV lead position, Device programming, Optimization, Vectorcardiography
- 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 TherapyDevice
A CRT device will be implanted while performing extra hemodynamic (LV dP/dtmax) and electrical (LVLED, VCG, and D-VCG) measurements. Devices and leads from various vendors will be used.
| Study group | Role | What they receive |
|---|---|---|
| CRT implantation | Experimental | Patients who have a class I indication for cardiac resynchronization therapy according to current international guidelines Receives: Device: Cardiac Resynchronization Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the increase in LV dP/dtmax and the D-VCG derived QRS area, obtained at different AV- and VV-intervals.
The optimal AV- and VV-interval produces the maximal increase in LV dP/dtmax. It is investigated whether the maximal increase in LV dP/dtmax also corresponds to the minimal QRS area derived from the D-VCG. The correlations will be expressed by the Pearson Correlation coefficient.
Measured: Acute measurements are performed for the duration of the CRT implantation procedure, an expected average of three hours
Correlation between the increase in LV dP/dtmax and the LVLED or VCG derived QRS area, obtained at different potential LV lead positions
The optimal LV lead position produces the maximal increase in LV dP/dtmax. It is investigated whether the maximal increase in LV dP/dtmax also corresponds to the longest LVLED or the minimal QRS area derived from the VCG. The correlations will be expressed by the Pearson Correlation coefficient.
Measured: Acute measurements are performed for the duration of the CRT implantation procedure, an expected average of three hours
Secondary outcomes (1)
Correlations between QRS vector area, -angle and -amplitude derived from VCG and from D-VCG.
The correlations will be expressed by the Pearson Correlation coefficient.
Measured: Acute measurements are performed for the duration of the CRT implantation procedure, an expected average of three hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen, Medtronic
- Responsible party
- Sponsor
- Investigators
- Kevin Vernooy, MD, PhD, Principal investigator, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326493
- Sponsor's protocol ID
- METC 13-2-046
- Status last verified
- Sep 2016
- First submitted
- 27 Nov 2014
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
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 15753115Moss AJ, Hall WJ, Cannom DS, Klein H, Brown MW, Daubert JP, Estes NA 3rd, Foster E, Greenberg H, Higgins SL, Pfeffer MA, Solomon SD, Wilber D, Zareba W; MADIT-CRT Trial Investigators. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009 Oct 1;361(14):1329-38. doi: 10.1056/NEJMoa0906431. Epub 2009 Sep 1.
PubMed 19723701European Heart Rhythm Association; European Society of Cardiology; Heart Rhythm Society; Heart Failure Society of America; American Society of Echocardiography; American Heart Association; European Association of Echocardiography; Heart Failure Association; Daubert JC, Saxon L, Adamson PB, Auricchio A, Berger RD, Beshai JF, Breithard O, Brignole M, Cleland J, Delurgio DB, Dickstein K, Exner DV, Gold M, Grimm RA, Hayes DL, Israel C, Leclercq C, Linde C, Lindenfeld J, Merkely B, Mont L, Murgatroyd F, Prinzen F, Saba SF, Shinbane JS, Singh J, Tang AS, Vardas PE, Wilkoff BL, Zamorano JL. 2012 EHRA/HRS expert consensus statement on cardiac resynchronization therapy in heart failure: implant and follow-up recommendations and management. Heart Rhythm. 2012 Sep;9(9):1524-76. doi: 10.1016/j.hrthm.2012.07.025. No abstract available.
PubMed 22939223Auricchio A, Prinzen FW. Non-responders to cardiac resynchronization therapy: the magnitude of the problem and the issues. Circ J. 2011;75(3):521-7. doi: 10.1253/circj.cj-10-1268. Epub 2011 Feb 11.
PubMed 21325727Cazeau S, Leclercq C, Lavergne T, Walker S, Varma C, Linde C, Garrigue S, Kappenberger L, Haywood GA, Santini M, Bailleul C, Daubert JC; Multisite Stimulation in Cardiomyopathies (MUSTIC) Study Investigators. Effects of multisite biventricular pacing in patients with heart failure and intraventricular conduction delay. N Engl J Med. 2001 Mar 22;344(12):873-80. doi: 10.1056/NEJM200103223441202.
PubMed 11259720Auricchio 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 10368116Auricchio A, Ding J, Spinelli JC, Kramer AP, Salo RW, Hoersch W, KenKnight BH, Klein HU. Cardiac resynchronization therapy restores optimal atrioventricular mechanical timing in heart failure patients with ventricular conduction delay. J Am Coll Cardiol. 2002 Apr 3;39(7):1163-9. doi: 10.1016/s0735-1097(02)01727-8.
PubMed 11923041Butter C, Auricchio A, Stellbrink C, Fleck E, Ding J, Yu Y, Huvelle E, Spinelli J; Pacing Therapy for Chronic Heart Failure II Study Group. Effect of resynchronization therapy stimulation site on the systolic function of heart failure patients. Circulation. 2001 Dec 18;104(25):3026-9. doi: 10.1161/hc5001.102229.
PubMed 11748094Sawhney NS, Waggoner AD, Garhwal S, Chawla MK, Osborn J, Faddis MN. Randomized prospective trial of atrioventricular delay programming for cardiac resynchronization therapy. Heart Rhythm. 2004 Nov;1(5):562-7. doi: 10.1016/j.hrthm.2004.07.006.
PubMed 15851220Morales MA, Startari U, Panchetti L, Rossi A, Piacenti M. Atrioventricular delay optimization by doppler-derived left ventricular dP/dt improves 6-month outcome of resynchronized patients. Pacing Clin Electrophysiol. 2006 Jun;29(6):564-8. doi: 10.1111/j.1540-8159.2006.00402.x.
PubMed 16784420Hardt SE, Yazdi SH, Bauer A, Filusch A, Korosoglou G, Hansen A, Bekeredjian R, Ehlermann P, Remppis A, Katus HA, Kuecherer HF. Immediate and chronic effects of AV-delay optimization in patients with cardiac resynchronization therapy. Int J Cardiol. 2007 Feb 14;115(3):318-25. doi: 10.1016/j.ijcard.2006.03.015. Epub 2006 Aug 7.
PubMed 16891011Delnoy PP, Ottervanger JP, Luttikhuis HO, Vos DH, Elvan A, Ramdat Misier AR, Beukema WP, Steendijk P, van Hemel NM. Pressure-volume loop analysis during implantation of biventricular pacemaker/cardiac resynchronization therapy device to optimize right and left ventricular pacing sites. Eur Heart J. 2009 Apr;30(7):797-804. doi: 10.1093/eurheartj/ehp011. Epub 2009 Feb 7.
PubMed 19202156Derval N, Steendijk P, Gula LJ, Deplagne A, Laborderie J, Sacher F, Knecht S, Wright M, Nault I, Ploux S, Ritter P, Bordachar P, Lafitte S, Reant P, Klein GJ, Narayan SM, Garrigue S, Hocini M, Haissaguerre M, Clementy J, Jais P. Optimizing hemodynamics in heart failure patients by systematic screening of left ventricular pacing sites: the lateral left ventricular wall and the coronary sinus are rarely the best sites. J Am Coll Cardiol. 2010 Feb 9;55(6):566-75. doi: 10.1016/j.jacc.2009.08.045. Epub 2009 Nov 20.
PubMed 19931364van Campen CM, Visser FC, de Cock CC, Vos HS, Kamp O, Visser CA. Comparison of the haemodynamics of different pacing sites in patients undergoing resynchronisation treatment: need for individualisation of lead localisation. Heart. 2006 Dec;92(12):1795-800. doi: 10.1136/hrt.2004.050435. Epub 2006 Jun 27.
PubMed 16803940Cuoco FA, Gold MR. Optimization of cardiac resynchronization therapy: importance of programmed parameters. J Cardiovasc Electrophysiol. 2012 Jan;23(1):110-8. doi: 10.1111/j.1540-8167.2011.02235.x. Epub 2011 Dec 21.
PubMed 22188487
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailor-CRT: Better Application of Cardiac Resynchronization Therapy by Automated and Improved Selection of Location and Timing of Stimulation
- ClinicalTrials.gov ID
- NCT02326493
- Acronym / sponsor ID
- METC 13-2-046
- Conditions
- Heart Failure, Left Bundle-Branch Block
- Keywords
- Cardiac Resynchronization Therapy, LV lead position, Device programming, Optimization, Vectorcardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- University Medical Center Groningen, Medtronic
- Study start
- Nov 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 29 Dec 2014 (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.
Approximately one third of patients treated with cardiac resynchronization therapy (CRT) do not derive any clinical benefit. CRT response can be improved by tailoring LV lead placement and programming of atrio-ventricular (AV) and inter-ventricular (VV) stimulation intervals to the individual patient. However, the best strategy to optimize lead positioning and device programming still remains to be established. Earlier work in our research group suggests that the vector cardiogram (VCG) can be used to determine the optimal LV lead position and AV- and VV-intervals, and pilot studies showed the feasibility to derive a VCG-like signal (D-VCG) from the implanted pacing electrodes. Other studies have suggested that the best position for the LV electrode is the region of latest electrical activation. The region of latest electrical activation can be identified by measuring the electrical delay on the LV lead (LVLED) during implantation. The objective of this study is to investigate whether D-VCG can be used to determine the optimal AV- and VV-interval and whether VCG and LVLED can be used to determine the optimal LV lead position.
Detailed description
Cardiac resynchronization therapy (CRT) is an established treatment for heart failure (HF) patients with severe left ventricular (LV) systolic impairment and delayed electrical impulse conduction through the ventricles, such as left bundle-branch block (LBBB). Since initial approval of the therapy over 10 years ago, there have been hundreds of thousands of implants worldwide. In The Netherlands, currently more than 2000 CRT devices are implanted each year. In a heart with LBBB, electrical activation of the lateral LV free wall is delayed, which leads to dyssynchronous and inefficient LV mechanical contraction and compromised LV pump function. The positive impact of CRT on LV pump function is attributed to paced pre-excitation of the delayed activated lateral LV wall. CRT is most commonly applied by pacing the right ventricle (RV) and LV lateral wall (almost) simultaneously. This corrects the abnormal LV electrical activation and resynchronizes LV mechanical contraction, which in turn results in improved LV pump function.
Despite the striking effectiveness of CRT, 30-50% of apparently suitable patients show little or no improvement. Previous studies have shown that the response to CRT can be improved by tailoring LV lead placement and programming of atrioventricular (AV) and inter-ventricular (VV) stimulation intervals to the individual patient. In clinical practice, echocardiographic techniques are the most widely employed for CRT optimization. However these techniques are subject to large measurement errors and inter- and intra-observer variability. A more accurate technique is invasive assessment of acute hemodynamic response to CRT, with the most widely used invasive hemodynamic parameter being the maximum rate of LV systolic pressure rise (LVdP/dtmax). However, the invasive and time-consuming nature of this approach limits its use in clinical practice. Thus, the best strategy to optimize lead positioning and device programming still remains to be established.
Earlier work in our research group suggests that the vectorcardiogram (VCG) can be used to determine the optimal LV lead position and AV- and VV-intervals, and pilot studies showed the feasibility to derive a VCG-like signal (D-VCG) from the implanted pacing electrodes. Other studies have suggested that the best position for the LV electrode is the region of latest electrical activation. The region of latest electrical activation can be identified by measuring the electrical delay on the LV lead (LVLED) during implantation. Validation of these techniques for tailoring LV lead positioning and AV- and VV- stimulation intervals to the individual patient, will provide non-invasive and easy methods to optimize CRT application and improve response rate.
The objective of this study is to investigate whether D-VCG can be used to determine the optimal AV- and VV-interval and whether VCG and LVLED can be used to determine the optimal LV lead position. Validation of these techniques for tailoring LV lead positioning and AV- and VV- stimulation intervals to the individual patient, will provide non-invasive and easy methods to optimize CRT application and improve response rate.
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 TherapyPatients who have a class I indication for cardiac resynchronization therapy according to current international guidelines |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic heart failure with NYHA functional class II-IV
- Left ventricular ejection fraction (LVEF) < 35%
- Left bundle-branch block (LBBB) with QRS duration > 120 ms
- In sinus rhythm
Key exclusion criteria (5 listed)
- Atrial fibrillation
- ≥4 premature ventricular complexes on standard 12-lead ECG
- Age <18 years or > 80 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 TherapyA CRT device will be implanted while performing extra hemodynamic (LV dP/dtmax) and electrical (LVLED, VCG, and D-VCG) measurements. Devices and leads from various vendors will be used. | Device | CRT implantation |
Primary outcome
Correlation between the increase in LV dP/dtmax and the D-VCG derived QRS area, obtained at different AV- and VV-intervals.
Time frame: Acute measurements are performed for the duration of the CRT implantation procedure, an expected average of three hours
The optimal AV- and VV-interval produces the maximal increase in LV dP/dtmax. It is investigated whether the maximal increase in LV dP/dtmax also corresponds to the minimal QRS area derived from the D-VCG. The correlations will be expressed by the Pearson Correlation coefficient.
Correlation between the increase in LV dP/dtmax and the LVLED or VCG derived QRS area, obtained at different potential LV lead positions
Time frame: Acute measurements are performed for the duration of the CRT implantation procedure, an expected average of three hours
The optimal LV lead position produces the maximal increase in LV dP/dtmax. It is investigated whether the maximal increase in LV dP/dtmax also corresponds to the longest LVLED or the minimal QRS area derived from the VCG. The correlations will be expressed by the Pearson Correlation coefficient.
1 secondary outcome
Correlations between QRS vector area, -angle and -amplitude derived from VCG and from D-VCG.
Time frame: Acute measurements are performed for the duration of the CRT implantation procedure, an expected average of three 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 23 Feb 2017.
- 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 19723701Moss AJ, Hall WJ, Cannom DS, Klein H, Brown MW, Daubert JP, Estes NA 3rd, Foster E, Greenberg H, Higgins SL, Pfeffer MA, Solomon SD, Wilber D, Zareba W; MADIT-CRT Trial Investigators. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009 Oct 1;361(14):1329-38. doi: 10.1056/NEJMoa0906431. Epub 2009 Sep 1.
- Background: PubMed 22939223European Heart Rhythm Association; European Society of Cardiology; Heart Rhythm Society; Heart Failure Society of America; American Society of Echocardiography; American Heart Association; European Association of Echocardiography; Heart Failure Association; Daubert JC, Saxon L, Adamson PB, Auricchio A, Berger RD, Beshai JF, Breithard O, Brignole M, Cleland J, Delurgio DB, Dickstein K, Exner DV, Gold M, Grimm RA, Hayes DL, Israel C, Leclercq C, Linde C, Lindenfeld J, Merkely B, Mont L, Murgatroyd F, Prinzen F, Saba SF, Shinbane JS, Singh J, Tang AS, Vardas PE, Wilkoff BL, Zamorano JL. 2012 EHRA/HRS expert consensus statement on cardiac resynchronization therapy in heart failure: implant and follow-up recommendations and management. Heart Rhythm. 2012 Sep;9(9):1524-76. doi: 10.1016/j.hrthm.2012.07.025. No abstract available.
- Background: PubMed 21325727Auricchio A, Prinzen FW. Non-responders to cardiac resynchronization therapy: the magnitude of the problem and the issues. Circ J. 2011;75(3):521-7. doi: 10.1253/circj.cj-10-1268. Epub 2011 Feb 11.
- Background: PubMed 11259720Cazeau S, Leclercq C, Lavergne T, Walker S, Varma C, Linde C, Garrigue S, Kappenberger L, Haywood GA, Santini M, Bailleul C, Daubert JC; Multisite Stimulation in Cardiomyopathies (MUSTIC) Study Investigators. Effects of multisite biventricular pacing in patients with heart failure and intraventricular conduction delay. N Engl J Med. 2001 Mar 22;344(12):873-80. doi: 10.1056/NEJM200103223441202.
- 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 11923041Auricchio A, Ding J, Spinelli JC, Kramer AP, Salo RW, Hoersch W, KenKnight BH, Klein HU. Cardiac resynchronization therapy restores optimal atrioventricular mechanical timing in heart failure patients with ventricular conduction delay. J Am Coll Cardiol. 2002 Apr 3;39(7):1163-9. doi: 10.1016/s0735-1097(02)01727-8.
- Background: PubMed 11748094Butter C, Auricchio A, Stellbrink C, Fleck E, Ding J, Yu Y, Huvelle E, Spinelli J; Pacing Therapy for Chronic Heart Failure II Study Group. Effect of resynchronization therapy stimulation site on the systolic function of heart failure patients. Circulation. 2001 Dec 18;104(25):3026-9. doi: 10.1161/hc5001.102229.
- Background: PubMed 15851220Sawhney NS, Waggoner AD, Garhwal S, Chawla MK, Osborn J, Faddis MN. Randomized prospective trial of atrioventricular delay programming for cardiac resynchronization therapy. Heart Rhythm. 2004 Nov;1(5):562-7. doi: 10.1016/j.hrthm.2004.07.006.
- Background: PubMed 16784420Morales MA, Startari U, Panchetti L, Rossi A, Piacenti M. Atrioventricular delay optimization by doppler-derived left ventricular dP/dt improves 6-month outcome of resynchronized patients. Pacing Clin Electrophysiol. 2006 Jun;29(6):564-8. doi: 10.1111/j.1540-8159.2006.00402.x.
- Background: PubMed 16891011Hardt SE, Yazdi SH, Bauer A, Filusch A, Korosoglou G, Hansen A, Bekeredjian R, Ehlermann P, Remppis A, Katus HA, Kuecherer HF. Immediate and chronic effects of AV-delay optimization in patients with cardiac resynchronization therapy. Int J Cardiol. 2007 Feb 14;115(3):318-25. doi: 10.1016/j.ijcard.2006.03.015. Epub 2006 Aug 7.
- Background: PubMed 19202156Delnoy PP, Ottervanger JP, Luttikhuis HO, Vos DH, Elvan A, Ramdat Misier AR, Beukema WP, Steendijk P, van Hemel NM. Pressure-volume loop analysis during implantation of biventricular pacemaker/cardiac resynchronization therapy device to optimize right and left ventricular pacing sites. Eur Heart J. 2009 Apr;30(7):797-804. doi: 10.1093/eurheartj/ehp011. Epub 2009 Feb 7.
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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 in people with Heart Failure and Left Bundle-Branch Block, 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 4 inclusion and 5 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 23 Feb 2017. 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?
Correlation between the increase in LV dP/dtmax and the D-VCG derived QRS area, obtained at different AV- and VV-intervals. (time frame: Acute measurements are performed for the duration of the CRT implantation procedure, an expected average of three hours). The study lists 2 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 NCT02326493, which also lists 18 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 23 Feb 2017.