Right Bundle-Branch BlockNCT05936294
Adaptive Cardiac Resynchronization Therapy in Patients With RBBB
A study testing Optimization of CRT Device in people with Right Bundle-Branch Block, run by Henry Ford Health System at 2 sites in United States.
Trial summary
This study will address whether acute adaptive RV pacing in sinus rhythm patients with severe LV systolic dysfunction and RBBB is superior to no ventricular pacing, and is as effective as echocardiographically optimized biventricular (BIV) pacing based on Medtronic ECG belt and cardiac performance as assessed by the… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Right Bundle-Branch Block
- What is being tested?
- Optimization of CRT Device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Sep 2017to 31 Mar 2021
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sinus rhythm or isolated atrial pacing
- LV systolic dysfunction (EF <35% at time of device implant)
- AV conduction <250 ms, RBBB, and
- have an implanted CRT device based on the ACC/AHA/HRS guidelines (2, 18) or will have a CRT device implanted during the study enrollment per ACC/AHA/HRS guidelines (2).
Who cannot join
- atrial fibrillation
- atrial flutter
- atrial tachycardia
- AV delay > 250 ms
- sinus tachycardia with resting heart rate at time of the study 100 bpm
- frequent APCs (> 25% of the total beats/min) or PVCs (>20% of the total beats/min), or
- patients with EF > 40% at time of enrollment (if LV systolic function was found to be improved from time of implant).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Henry Ford Hospital
Detroit, Michigan, 48202
Central Arkansas Veterans Healthare System
Little Rock, Arkansas, 72205
About this study
Official title: Cardiac Resynchronization Therapy With Synchronized RV Pacing to Improve Cardiac Function in Patients With Right Bundle Branch Block and Systolic LV Dysfunction
This study will address whether acute adaptive RV pacing in sinus rhythm patients with severe LV systolic dysfunction and RBBB is superior to no ventricular pacing, and is as effective as echocardiographically optimized biventricular (BIV) pacing based on Medtronic ECG belt and cardiac performance as assessed by the echocardiographic parameters of RV and LV function.
Read the detailed description
Current guidelines state that CRT implantation is less beneficial for patients with RBBB compared to those with LBBB (2). Current evidence suggests that frequent or persistent RV-only pacing in patients with narrow QRS and LV dysfunction can be harmful due to ventricular desynchronization attributable to RV apex pacing (3-5).
Studies suggest that LV-only pacing is not inferior to BIV pacing in sinus rhythm patients with LV dysfunction and LBBB and ICD back up (6,7). A novel algorithm of CRT by delivering synchronized LV pacing with the intrinsic conduction in patients with severe LV systolic dysfunction and LBBB (adaptive CRT) has been demonstrated to show that it is at least as effective as protocol-driven echocardiographic optimization. It also has shown a significant reduction in the probability of 30-day readmission for both HF and all-cause hospitalizations, 46% reduced incidence of AF compared to conventional CRT, and prolongation of CRT device battery life (8-10). Patients who had an adaptive CRT algorithm that provided > 50% synchronized LV pacing or had normal AV conduction with the adaptive CRT algorithm had decreased risk of death or heart failure hospitalization when compared to those with <50% synchronized LV pacing or echocardiography-optimized BIV pacing respectively (11). In another acute study the LV dP/dtmax was higher with LV than BIV pacing when LV pacing was associated with ventricular fusion caused by intrinsic activation (12).
Several studies have suggested that optimization of the programmed atrioventricular delay (AVD) and interventricular delay (VVD) delays may incrementally improve the long-term outcome of BIV pacing (13-15).
The lateral LV wall contracts early in patients with RBBB when compared to LBBB so LV pacing in the CRT devices is less likely to be beneficial. . In an experimental study of 12 dogs with tachycardia-induced cardiomyopathy and RBBB (6 dogs) or LBBB (6 dogs) (16), RV-only pacing enhanced LV function and synchrony as seen by dP/dtmax measured by catheter tip placed in the LV chamber and synchrony evaluation by cardiac MRI in the RBBB group as well or better than BIV pacing. LV-only pacing worsened function in the RBBB group.
RV-only pacing was also evaluated in a prospective study of 7 patients with RBBB and RV dysfunction with most patients having congenital heart disease. LV global function was intact at baseline (17). Sequential atrioventricular RV pacing with an atrioventricular delay of 90% of the PR interval was superior to atrial-only pacing for both improvement in RV dP/dtmax and LV cardiac index as seen at cardiac catheterization. The RV dP/dtmax increased by 22% in RBBB patients with RV pacing and QRS decreased from 163 +/- 39 to 126 +/- 31 ms. The two studies together suggest that most of the benefit from BIV pacing in patients with RBBB and HF is due to the RV pacing component and the benefit might be reduced due to the LV pacing component. Better timing of RV pacing in patients with RBBB might significantly decrease desynchronization from RV pacing and maximize the benefit of RV pacing as seen in adaptive LV-pacing CRT in patients with LBBB and LV systolic dysfunction.
These studies have led to the current hypothesis that adaptive RV pacing using RV-only pacing synchronized to LV activation when intrinsic AV conduction is normal is more physiological and will improve RV and LV function by Echocardiography parameters and on Medtronic ECG belt for activation in patients with RBBB and LV dysfunction because of improved synchronization and narrowing the QRS duration.
As a secondary goal, battery life with BIV pacing will be compared to adaptive RV pacing assuming at least 50% of RV-only pacing will be achieved with adaptive CRT for RBBB.
- Conditions
- Right Bundle-Branch Block
- Being tested
- Optimization of CRT Device
- Medical subject headings
- Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimization of CRT DeviceDiagnostic test
Each patient will have atrial pacing 10% higher than the sinus rate or atrial pacing at a rate of 60 bpm if significant sinus bradycardia is present. Each patient will have six ECGs and echocardiographic sequences performed in the same session. In addition six electrical activation evaluations by the Medtronic ECG belt will be done as well. The first study will always be with no ventricular pacing. One study will be echocardiography-optimized BIV pacing and four studies for echocardiography-optimized (?) adaptive RV-only pacing with different AV intervals. A random-sequence will be performed to determine the order for the rest of the studies.
| Study group | Role | What they receive |
|---|---|---|
| CRT Optimization | Other | Each patient will have atrial pacing 10% higher than the sinus rate or atrial pacing at a rate of 60 bpm if significant sinus bradycardia is present. Each patient will have six ECGs and echocardiographic sequences performed in the same session. In addition six electrical activation evaluations by the Medtronic ECG belt will be done as well. The first study will always be with no ventricular pacing. One study will be echocardiography-optimized BIV pacing and four studies for echocardiography-optimized (?) adaptive RV-only pacing with different AV intervals. A random-sequence will be performed to determine the order for the rest of the studies. Receives: Diagnostic Test: Optimization of CRT Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of adaptive Right Ventricular (RV) pacing
Echocardiographic parameters to measure cardiac function, including:
- Left Ventricular Outflow Tract velocity time interval(LVOT VTI),
- dP/dt of Left Ventricle (LV) and RV,
- Myocardial Performance Index (MPI),
- Right Ventricular Outflow Tractvelocity time interval (RVOT VTI); and
- 3D derived Systolic Dyssynchrony Index (SDI).
Measured: 1 hour
Secondary outcomes (1)
Battery/device longevity
Calculations of current drain and pacing percentages for RV-only pacing versus BIV pacing. Measured by microjoule current consumption.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start15 Sep 2017
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Right Bundle-Branch BlockStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Central Arkansas Veterans Healthcare System
- Responsible party
- Principal investigator, Dr. Waddah Maskoun, Henry Ford Health System
- Investigators
- Waddah Maskoun, MD, Principal investigator, Henry Ford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936294
- Sponsor's protocol ID
- E17154
- Status last verified
- Jun 2023
- First submitted
- 7 Aug 2019
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Surawicz B, Childers R, Deal BJ, Gettes LS, Bailey JJ, Gorgels A, Hancock EW, Josephson M, Kligfield P, Kors JA, Macfarlane P, Mason JW, Mirvis DM, Okin P, Pahlm O, Rautaharju PM, van Herpen G, Wagner GS, Wellens H; American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; American College of Cardiology Foundation; Heart Rhythm Society. AHA/ACCF/HRS recommendations for the standardization and interpretation of the electrocardiogram: part III: intraventricular conduction disturbances: a scientific statement from the American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; the American College of Cardiology Foundation; and the Heart Rhythm Society. Endorsed by the International Society for Computerized Electrocardiology. J Am Coll Cardiol. 2009 Mar 17;53(11):976-81. doi: 10.1016/j.jacc.2008.12.013. No abstract available.
PubMed 19281930Tracy CM, Epstein AE, Darbar D, Dimarco JP, Dunbar SB, Estes NA 3rd, Ferguson TB Jr, Hammill SC, Karasik PE, Link MS, Marine JE, Schoenfeld MH, Shanker AJ, Silka MJ, Stevenson LW, Stevenson WG, Varosy PD. 2012 ACCF/AHA/HRS focused update of the 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2012 Oct 2;60(14):1297-313. doi: 10.1016/j.jacc.2012.07.009. Epub 2012 Sep 10. No abstract available.
PubMed 22975230Wilkoff 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 12495391Steinberg 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 15828875Sharma AD, Rizo-Patron C, Hallstrom AP, O'Neill GP, Rothbart S, Martins JB, Roelke M, Steinberg JS, Greene HL; DAVID Investigators. Percent right ventricular pacing predicts outcomes in the DAVID trial. Heart Rhythm. 2005 Aug;2(8):830-4. doi: 10.1016/j.hrthm.2005.05.015.
PubMed 16051118Boriani G, Gardini B, Diemberger I, Bacchi Reggiani ML, Biffi M, Martignani C, Ziacchi M, Valzania C, Gasparini M, Padeletti L, Branzi A. Meta-analysis of randomized controlled trials evaluating left ventricular vs. biventricular pacing in heart failure: effect on all-cause mortality and hospitalizations. Eur J Heart Fail. 2012 Jun;14(6):652-60. doi: 10.1093/eurjhf/hfs040. Epub 2012 Apr 17.
PubMed 22510423Boriani G, Kranig W, Donal E, Calo L, Casella M, Delarche N, Lozano IF, Ansalone G, Biffi M, Boulogne E, Leclercq C; B-LEFT HF study group. A randomized double-blind comparison of biventricular versus left ventricular stimulation for cardiac resynchronization therapy: the Biventricular versus Left Univentricular Pacing with ICD Back-up in Heart Failure Patients (B-LEFT HF) trial. Am Heart J. 2010 Jun;159(6):1052-1058.e1. doi: 10.1016/j.ahj.2010.03.008.
PubMed 20569719Martin DO, Lemke B, Birnie D, Krum H, Lee KL, Aonuma K, Gasparini M, Starling RC, Milasinovic G, Rogers T, Sambelashvili A, Gorcsan J 3rd, Houmsse M; Adaptive CRT Study Investigators. Investigation of a novel algorithm for synchronized left-ventricular pacing and ambulatory optimization of cardiac resynchronization therapy: results of the adaptive CRT trial. Heart Rhythm. 2012 Nov;9(11):1807-14. doi: 10.1016/j.hrthm.2012.07.009. Epub 2012 Jul 14.
PubMed 22796472Gasparini M, Birnie D, Lemke B, Aonuma K, Lee KL, Gorcsan J 3rd, Landolina M, Klepfer R, Meloni S, Cicconelli M, Grammatico A, Martin DO. Adaptive Cardiac Resynchronization Therapy Reduces Atrial Fibrillation Incidence in Heart Failure Patients With Prolonged AV Conduction: The Adaptive CRT Randomized Trial. Circ Arrhythm Electrophysiol. 2019 May;12(5):e007260. doi: 10.1161/CIRCEP.119.007260. No abstract available.
PubMed 30991823Starling RC, Krum H, Bril S, Tsintzos SI, Rogers T, Hudnall JH, Martin DO. Impact of a Novel Adaptive Optimization Algorithm on 30-Day Readmissions: Evidence From the Adaptive CRT Trial. JACC Heart Fail. 2015 Jul;3(7):565-572. doi: 10.1016/j.jchf.2015.03.001. Epub 2015 Jun 10.
PubMed 26071616Birnie D, Lemke B, Aonuma K, Krum H, Lee KL, Gasparini M, Starling RC, Milasinovic G, Gorcsan J 3rd, Houmsse M, Abeyratne A, Sambelashvili A, Martin DO. Clinical outcomes with synchronized left ventricular pacing: analysis of the adaptive CRT trial. Heart Rhythm. 2013 Sep;10(9):1368-74. doi: 10.1016/j.hrthm.2013.07.007. Epub 2013 Jul 11.
PubMed 23851059van Gelder BM, Bracke FA, Meijer A, Pijls NH. The hemodynamic effect of intrinsic conduction during left ventricular pacing as compared to biventricular pacing. J Am Coll Cardiol. 2005 Dec 20;46(12):2305-10. doi: 10.1016/j.jacc.2005.02.098.
PubMed 16360063Sawhney 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 16784420Vidal B, Sitges M, Marigliano A, Delgado V, Diaz-Infante E, Azqueta M, Tamborero D, Tolosana JM, Berruezo A, Perez-Villa F, Pare C, Mont L, Brugada J. Optimizing the programation of cardiac resynchronization therapy devices in patients with heart failure and left bundle branch block. Am J Cardiol. 2007 Sep 15;100(6):1002-6. doi: 10.1016/j.amjcard.2007.04.046. Epub 2007 Jul 5.
PubMed 17826387
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Resynchronization Therapy With Synchronized RV Pacing to Improve Cardiac Function in Patients With Right Bundle Branch Block and Systolic LV Dysfunction
- ClinicalTrials.gov ID
- NCT05936294
- Acronym / sponsor ID
- E17154
- Conditions
- Right Bundle-Branch Block
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Central Arkansas Veterans Healthcare System
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 7 Jul 2023 (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.
This study will address whether acute adaptive RV pacing in sinus rhythm patients with severe LV systolic dysfunction and RBBB is superior to no ventricular pacing, and is as effective as echocardiographically optimized biventricular (BIV) pacing based on Medtronic ECG belt and cardiac performance as assessed by the echocardiographic parameters of RV and LV function.
Detailed description
Current guidelines state that CRT implantation is less beneficial for patients with RBBB compared to those with LBBB (2). Current evidence suggests that frequent or persistent RV-only pacing in patients with narrow QRS and LV dysfunction can be harmful due to ventricular desynchronization attributable to RV apex pacing (3-5).
Studies suggest that LV-only pacing is not inferior to BIV pacing in sinus rhythm patients with LV dysfunction and LBBB and ICD back up (6,7). A novel algorithm of CRT by delivering synchronized LV pacing with the intrinsic conduction in patients with severe LV systolic dysfunction and LBBB (adaptive CRT) has been demonstrated to show that it is at least as effective as protocol-driven echocardiographic optimization. It also has shown a significant reduction in the probability of 30-day readmission for both HF and all-cause hospitalizations, 46% reduced incidence of AF compared to conventional CRT, and prolongation of CRT device battery life (8-10). Patients who had an adaptive CRT algorithm that provided > 50% synchronized LV pacing or had normal AV conduction with the adaptive CRT algorithm had decreased risk of death or heart failure hospitalization when compared to those with <50% synchronized LV pacing or echocardiography-optimized BIV pacing respectively (11). In another acute study the LV dP/dtmax was higher with LV than BIV pacing when LV pacing was associated with ventricular fusion caused by intrinsic activation (12).
Several studies have suggested that optimization of the programmed atrioventricular delay (AVD) and interventricular delay (VVD) delays may incrementally improve the long-term outcome of BIV pacing (13-15).
The lateral LV wall contracts early in patients with RBBB when compared to LBBB so LV pacing in the CRT devices is less likely to be beneficial. . In an experimental study of 12 dogs with tachycardia-induced cardiomyopathy and RBBB (6 dogs) or LBBB (6 dogs) (16), RV-only pacing enhanced LV function and synchrony as seen by dP/dtmax measured by catheter tip placed in the LV chamber and synchrony evaluation by cardiac MRI in the RBBB group as well or better than BIV pacing. LV-only pacing worsened function in the RBBB group.
RV-only pacing was also evaluated in a prospective study of 7 patients with RBBB and RV dysfunction with most patients having congenital heart disease. LV global function was intact at baseline (17). Sequential atrioventricular RV pacing with an atrioventricular delay of 90% of the PR interval was superior to atrial-only pacing for both improvement in RV dP/dtmax and LV cardiac index as seen at cardiac catheterization. The RV dP/dtmax increased by 22% in RBBB patients with RV pacing and QRS decreased from 163 +/- 39 to 126 +/- 31 ms. The two studies together suggest that most of the benefit from BIV pacing in patients with RBBB and HF is due to the RV pacing component and the benefit might be reduced due to the LV pacing component. Better timing of RV pacing in patients with RBBB might significantly decrease desynchronization from RV pacing and maximize the benefit of RV pacing as seen in adaptive LV-pacing CRT in patients with LBBB and LV systolic dysfunction.
These studies have led to the current hypothesis that adaptive RV pacing using RV-only pacing synchronized to LV activation when intrinsic AV conduction is normal is more physiological and will improve RV and LV function by Echocardiography parameters and on Medtronic ECG belt for activation in patients with RBBB and LV dysfunction because of improved synchronization and narrowing the QRS duration.
As a secondary goal, battery life with BIV pacing will be compared to adaptive RV pacing assuming at least 50% of RV-only pacing will be achieved with adaptive CRT for RBBB.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRT Optimization | Other | Diagnostic Test: Optimization of CRT DeviceEach patient will have atrial pacing 10% higher than the sinus rate or atrial pacing at a rate of 60 bpm if significant sinus bradycardia is present. Each patient will have six ECGs and echocardiographic sequences performed in the same session. In addition six electrical activation evaluations by the Medtronic ECG belt will be done as well. The first study will always be with no ventricular pacing. One study will be echocardiography-optimized BIV pacing and four studies for echocardiography-optimized (?) adaptive RV-only pacing with different AV intervals. A random-sequence will be performed to determine the order for the rest of the studies. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- sinus rhythm or isolated atrial pacing
- LV systolic dysfunction (EF <35% at time of device implant)
- AV conduction <250 ms, RBBB, and
- have an implanted CRT device based on the ACC/AHA/HRS guidelines (2, 18) or will have a CRT device implanted during the study enrollment per ACC/AHA/HRS guidelines (2).
Key exclusion criteria (7 listed)
- atrial fibrillation
- atrial flutter
- atrial tachycardia
- AV delay > 250 ms
- sinus tachycardia with resting heart rate at time of the study 100 bpm
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 |
|---|---|---|
| Optimization of CRT DeviceEach patient will have atrial pacing 10% higher than the sinus rate or atrial pacing at a rate of 60 bpm if significant sinus bradycardia is present. Each patient will have six ECGs and echocardiographic sequences performed in the same session. In addition six electrical activation evaluations by the Medtronic ECG belt will be done as well. The first study will always be with no ventricular pacing. One study will be echocardiography-optimized BIV pacing and four studies for echocardiography-optimized (?) adaptive RV-only pacing with different AV intervals. A random-sequence will be performed to determine the order for the rest of the studies. | Diagnostic test | CRT Optimization |
Primary outcome
Effectiveness of adaptive Right Ventricular (RV) pacing
Time frame: 1 hour
Echocardiographic parameters to measure cardiac function, including: 1. Left Ventricular Outflow Tract velocity time interval(LVOT VTI), 2. dP/dt of Left Ventricle (LV) and RV, 3. Myocardial Performance Index (MPI), 4. Right Ventricular Outflow Tractvelocity time interval (RVOT VTI); and 5. 3D derived Systolic Dyssynchrony Index (SDI).
1 secondary outcome
Battery/device longevity
Time frame: 1 hour
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Background: PubMed 19281930Surawicz B, Childers R, Deal BJ, Gettes LS, Bailey JJ, Gorgels A, Hancock EW, Josephson M, Kligfield P, Kors JA, Macfarlane P, Mason JW, Mirvis DM, Okin P, Pahlm O, Rautaharju PM, van Herpen G, Wagner GS, Wellens H; American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; American College of Cardiology Foundation; Heart Rhythm Society. AHA/ACCF/HRS recommendations for the standardization and interpretation of the electrocardiogram: part III: intraventricular conduction disturbances: a scientific statement from the American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; the American College of Cardiology Foundation; and the Heart Rhythm Society. Endorsed by the International Society for Computerized Electrocardiology. J Am Coll Cardiol. 2009 Mar 17;53(11):976-81. doi: 10.1016/j.jacc.2008.12.013. No abstract available.
- Background: PubMed 22975230Tracy CM, Epstein AE, Darbar D, Dimarco JP, Dunbar SB, Estes NA 3rd, Ferguson TB Jr, Hammill SC, Karasik PE, Link MS, Marine JE, Schoenfeld MH, Shanker AJ, Silka MJ, Stevenson LW, Stevenson WG, Varosy PD. 2012 ACCF/AHA/HRS focused update of the 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2012 Oct 2;60(14):1297-313. doi: 10.1016/j.jacc.2012.07.009. Epub 2012 Sep 10. No abstract available.
- 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 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 16051118Sharma AD, Rizo-Patron C, Hallstrom AP, O'Neill GP, Rothbart S, Martins JB, Roelke M, Steinberg JS, Greene HL; DAVID Investigators. Percent right ventricular pacing predicts outcomes in the DAVID trial. Heart Rhythm. 2005 Aug;2(8):830-4. doi: 10.1016/j.hrthm.2005.05.015.
- Background: PubMed 22510423Boriani G, Gardini B, Diemberger I, Bacchi Reggiani ML, Biffi M, Martignani C, Ziacchi M, Valzania C, Gasparini M, Padeletti L, Branzi A. Meta-analysis of randomized controlled trials evaluating left ventricular vs. biventricular pacing in heart failure: effect on all-cause mortality and hospitalizations. Eur J Heart Fail. 2012 Jun;14(6):652-60. doi: 10.1093/eurjhf/hfs040. Epub 2012 Apr 17.
- Background: PubMed 20569719Boriani G, Kranig W, Donal E, Calo L, Casella M, Delarche N, Lozano IF, Ansalone G, Biffi M, Boulogne E, Leclercq C; B-LEFT HF study group. A randomized double-blind comparison of biventricular versus left ventricular stimulation for cardiac resynchronization therapy: the Biventricular versus Left Univentricular Pacing with ICD Back-up in Heart Failure Patients (B-LEFT HF) trial. Am Heart J. 2010 Jun;159(6):1052-1058.e1. doi: 10.1016/j.ahj.2010.03.008.
- Background: PubMed 22796472Martin DO, Lemke B, Birnie D, Krum H, Lee KL, Aonuma K, Gasparini M, Starling RC, Milasinovic G, Rogers T, Sambelashvili A, Gorcsan J 3rd, Houmsse M; Adaptive CRT Study Investigators. Investigation of a novel algorithm for synchronized left-ventricular pacing and ambulatory optimization of cardiac resynchronization therapy: results of the adaptive CRT trial. Heart Rhythm. 2012 Nov;9(11):1807-14. doi: 10.1016/j.hrthm.2012.07.009. Epub 2012 Jul 14.
- Background: PubMed 30991823Gasparini M, Birnie D, Lemke B, Aonuma K, Lee KL, Gorcsan J 3rd, Landolina M, Klepfer R, Meloni S, Cicconelli M, Grammatico A, Martin DO. Adaptive Cardiac Resynchronization Therapy Reduces Atrial Fibrillation Incidence in Heart Failure Patients With Prolonged AV Conduction: The Adaptive CRT Randomized Trial. Circ Arrhythm Electrophysiol. 2019 May;12(5):e007260. doi: 10.1161/CIRCEP.119.007260. No abstract available.
- Background: PubMed 26071616Starling RC, Krum H, Bril S, Tsintzos SI, Rogers T, Hudnall JH, Martin DO. Impact of a Novel Adaptive Optimization Algorithm on 30-Day Readmissions: Evidence From the Adaptive CRT Trial. JACC Heart Fail. 2015 Jul;3(7):565-572. doi: 10.1016/j.jchf.2015.03.001. Epub 2015 Jun 10.
- Background: PubMed 23851059Birnie D, Lemke B, Aonuma K, Krum H, Lee KL, Gasparini M, Starling RC, Milasinovic G, Gorcsan J 3rd, Houmsse M, Abeyratne A, Sambelashvili A, Martin DO. Clinical outcomes with synchronized left ventricular pacing: analysis of the adaptive CRT trial. Heart Rhythm. 2013 Sep;10(9):1368-74. doi: 10.1016/j.hrthm.2013.07.007. Epub 2013 Jul 11.
- Background: PubMed 16360063van Gelder BM, Bracke FA, Meijer A, Pijls NH. The hemodynamic effect of intrinsic conduction during left ventricular pacing as compared to biventricular pacing. J Am Coll Cardiol. 2005 Dec 20;46(12):2305-10. doi: 10.1016/j.jacc.2005.02.098.
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Recruiting
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
Left Bundle Branch Area Pacing, Right Ventricular Pacing
Recruiting
Cardiac Contractility Modulation in Chagas Heart Disease
Chagas Cardiomyopathy, Heart Failure
Recruiting
His-Bundle Corrective Pacing in Heart Failure
Right Bundle-Branch Block, Heart Failure
Not yet recruiting
Prophylactic Permanent Pacemaker in Patients With Right Bundle Branch Block Undergoing Transcatheter Aortic Valve Implantation
Aortic Stenosis, Right Bundle-Branch Block
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.
Waddah Maskoun, MD principal investigator
Henry Ford
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimization of CRT Device in people with Right Bundle-Branch Block, run by Henry Ford Health System at 2 sites in United States.
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 7 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: stopped early, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 was stopped early (reason given: Low enrollment). Results are not available in the source record.
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?
Effectiveness of adaptive Right Ventricular (RV) pacing (time frame: 1 hour). 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 NCT05936294, which also lists 21 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 7 Jul 2023; AzTrials last refreshed its copy on 30 Oct 2026.