Dilated Cardiomyopathy with Conduction DefectCSP-SYNCNCT05155865
Conduction System Pacing Versus Biventricular Pacing for Cardiac ResYNChronization
A study testing Resynchronization with conduction system pacing and Cardiac resynchronization therapy with biventricular stimulation in people with Dilated Cardiomyopathy with Conduction Defect and Left Bundle-Branch Block, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
Cardiac resynchronization therapy (CRT) with biventricular pacing (BiV) is the cornerstone treatment for heart failure patients with ventricular dyssynchrony. Recently, a new concept, conduction system pacing (CSP) with permanent pacing, including His bundle pacing and left bundle branch pacing, has been proposed as a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dilated Cardiomyopathy with Conduction Defect, Left Bundle-Branch Block, Heart Failure
- What is being tested?
- Resynchronization with conduction system pacing and Cardiac resynchronization therapy with biventricular stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSlovenia
- Study dates
- 10 Jan 2022to 28 Oct 2024
- 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
- The proposed inclusion criteria represent the minimum recommendations for CRT implantation according to the ESC 2021 guidelines. In addition:
- Sinus rhythm and complete left bundle branch block according to Strauss criteria
- LVEF ≤35%
- NYHA class II-III
- Optimal medical heart failure therapy for at least 3 months before enrollment
- The patient is able to understand and willing to provide a written informed consent
- 18 years of age or older
Who cannot join
- Mechanical tricuspid valve replacement
- More than moderate valvular disease
- Unstable angina, acute MI, CABG, or PCI within the past 6 months
- Persistent or permanent atrial fibrillation
- Ventricular arrhythmias (frequent PVC) which do not allow to acquire consecutive regular beats during echocardiography and electrocardiography
- Higher degree AV block
Show all 9Show fewer
- Life expectancy of less than 12 months
- Pregnancy and breastfeeding
- Acute illness or active systemic infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conduction System Pacing Versus Biventricular Pacing for Cardiac ResYNChronization (CSP-SYNC)
Cardiac resynchronization therapy (CRT) with biventricular pacing (BiV) is the cornerstone treatment for heart failure patients with ventricular dyssynchrony. Recently, a new concept, conduction system pacing (CSP) with permanent pacing, including His bundle pacing and left bundle branch pacing, has been proposed as a potential alternative to conventional BiV-CRT. The prospective, randomized trial will compare echocardiographic, electrocardiographic, and clinical effects of CSP versus conventional BiV pacing in heart failure patients with reduced ejection fraction (LVEF ≤ 35%), sinus rhythm, and left bundle branch block. Patients will be randomized to either CSP or biventricular pacing study group and followed up for at least 6 months. The study will explore whether CSP is non-inferior to BiV pacing in echocardiographic, electrocardiographic, and clinical outcomes.
Read the detailed description
Cardiac resynchronization therapy (CRT) with biventricular pacing is an integral part of heart failure therapy in patients with reduced ejection fraction and wide QRS. Previous studies have demonstrated improved quality of life, reduced heart failure hospitalization, and decreased all-cause mortality. However, approx. 30% of patients still do not benefit from this therapy. High pacing thresholds and phrenic nerve stimulation are also common problems with BiV stimulation. Newer CRT systems with improved programmability and algorithms in conjunction with quadripolar left ventricular leads have solved some challenges of BiV pacing. However, BiV stimulation with non-physiological epicardial activation has shown a possible pro-arrhythmic effect which is more pronounced in the non-responder population.
On the other hand, CSP provides synchronous physiological ventricular activation with possible superior electrical and mechanical resynchronization compared to BiV pacing. Electrical activation maps obtained during CSP showed normalization of left bundle branch block with more homogeneous electrical resynchronization than in biventricular pacing. Additionally, BiV CRT effectively corrects mechanical dyssnchrony, demonstrated with homogenization of myocardial work. This has already been proven as the underlying pathophysiological mechanism for successful CRT response. However, the effect of CSP on echocardiographic parameters of mechanical dyssynchrony is not known.
Previous studies of CSP focused on feasibility and its benefits over right ventricular pacing in patients with refractory atrial fibrillation who underwent atrioventricular node ablation and pacemaker implantation. Promising results were followed by the acknowledgment of this physiological mode of pacing by the recent guidelines of European Society of Cardiology. However, studies evaluating the value of CSP as an alternative approach to BiV CRT in heart failure patients are limited. The purpose of this study is to compare the effects of CSP and conventional BiV pacing on electrocardiographic and echocardiographic parameters as well as on clinical outcomes in patients with heart failure with reduced ejection fraction (LVEF ≤35%), sinus rhythm, and left bundle branch block. In this single-center study, 60 patients will be randomized into one of two arms: a BiV pacing arm with BiV CRT implantation based on clinical guidelines or an experimental CSP arm with the implantation of a CSP device. Device with a defibrillator (ICD) will be selected at the discretion of the implanting physician. Baseline and follow up assessments will include clinical evaluation (New York Heart Association class, 6-minute walking distance), evaluation of quality of life (EQ-5D index), laboratory tests (N-terminal pro-B-type natriuretic peptide), electrocardiographic recordings (standard 12-leads ECG and high-resolution-ECG), and echocardiographic evaluation (standard echocardiographic parameters of LV reverse remodeling and non-invasive myocardial work assessment). Intra-operative and procedural parameters will also be recorded.
Investigators hypothesize that CSP could represent a feasible and safe alternative to conventional BiV pacing in terms of clinical, electrocardiographic, and echocardiographic outcomes.
- Conditions
- Dilated Cardiomyopathy with Conduction Defect, Left Bundle-Branch Block, Heart Failure, Resynchronization Therapy, Cardiac Remodeling, Ventricular
- Being tested
- Resynchronization with conduction system pacing, Cardiac resynchronization therapy with biventricular stimulation
- Keywords
- left bundle branch block, dilated cardiomyopathy, resynchronization therapy, myocardial work, arrhythmia
- Medical subject headings
- Idiopathic dilation cardiomyopathy, Bundle-Branch Block, Heart Failure, Ventricular Remodeling, Cardiomyopathy, Dilated, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resynchronization with conduction system pacingDevice
Implantation of permanent pacemaker with conduction system pacing (preferably left bundle branch) with or without defibrillator lead placement
Cardiac resynchronization therapy with biventricular stimulationDevice
Implantation of cardiac resynchronization therapy with biventricular stimulation with or without defibrillator lead placement
| Study group | Role | What they receive |
|---|---|---|
| Resynchronization with conduction system pacing | Experimental | Implantation of permanent pacemaker with conduction system pacing (preferably left bundle branch) with or without defibrillator lead placement. Optimal guidelines-based heart failure treatment and antiarrhythmic drugs. Receives: Device: Resynchronization with conduction system pacing |
| Cardiac resynchronization therapy with biventricular stimulation | Active comparator | Implantation of cardiac resynchronization therapy with biventricular stimulation with or without defibrillator lead placement. Optimal guidelines-based heart failure treatment and antiarrhythmic drugs. Receives: Device: Cardiac resynchronization therapy with biventricular stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular volume
Effect on reverse left ventricular remodeling measured as changes in left ventricular volume in both arms
Measured: acute after the procedure, 1 month, 6 months, 12 months
Change in left ventricular ejection fraction
Effect on reverse left ventricular remodeling measured as changes in left ventricular ejection fraction in both arms
Measured: acute procedure, 1 month, 6 months, 12 months
Difference in Heart Failure Class
From class 1 to 4
Measured: 6 months
Difference in pro-BNP value
pg/mL
Measured: 6 months
Difference in 6-minute walk test distance
meters
Measured: 6 months
Difference in the EQ-5D index
score
Measured: 6 months
Secondary outcomes (7)
Difference in myocardial work redistribution
Echo measurement
Measured: acute after the procedure, 1 month, 6 months, 12 months
Difference in QRS complex width
ms
Measured: acute after the procedure, 1 month, 6 months, 12 months
Difference in filtered QRS duration on high-resolution electrocardiogram
ms
Measured: acute after procedure, 1 month, 6 months, 12 months
Difference in sum absolute QRST integral
ms
Measured: acute after the procedure, 1 month, 6 months, 12 months
Difference in arrhythmia occurrence
Descriptive
Measured: at least 12 months after enrollment
Rate of procedural complications
Descriptive
Measured: at least 12 months after enrollment
Tpeak-end duration
ms
Measured: acute after the procedure, 1 month, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start10 Jan 2022
- Primary completion28 Oct 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Dilated Cardiomyopathy with Conduction DefectStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Žižek, MD, PhD, University Medical Centre Ljubljana
- Investigators
- Marta Cvijc, MD, Study chair, University Medical Centre Ljubljana (Slovenia)Anja Zupan Meznar, MD, Study chair, University Medical Centre Ljubljana (Slovenia)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155865
- Sponsor's protocol ID
- CSP-SYNC
- Acronym
- CSP-SYNC
- Status last verified
- Oct 2024
- First submitted
- 30 Nov 2021
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Sharma PS, Vijayaraman P. Conduction System Pacing for Cardiac Resynchronisation. Arrhythm Electrophysiol Rev. 2021 Apr;10(1):51-58. doi: 10.15420/aer.2020.45.
PubMed 33936744Herweg B, Welter-Frost A, Vijayaraman P. The evolution of cardiac resynchronization therapy and an introduction to conduction system pacing: a conceptual review. Europace. 2021 Apr 6;23(4):496-510. doi: 10.1093/europace/euaa264.
PubMed 33247913Wu S, Su L, Vijayaraman P, Zheng R, Cai M, Xu L, Shi R, Huang Z, Whinnett ZI, Huang W. Left Bundle Branch Pacing for Cardiac Resynchronization Therapy: Nonrandomized On-Treatment Comparison With His Bundle Pacing and Biventricular Pacing. Can J Cardiol. 2021 Feb;37(2):319-328. doi: 10.1016/j.cjca.2020.04.037. Epub 2020 May 7.
PubMed 32387225Vinther M, Risum N, Svendsen JH, Mogelvang R, Philbert BT. A Randomized Trial of His Pacing Versus Biventricular Pacing in Symptomatic HF Patients With Left Bundle Branch Block (His-Alternative). JACC Clin Electrophysiol. 2021 Nov;7(11):1422-1432. doi: 10.1016/j.jacep.2021.04.003. Epub 2021 Apr 25.
PubMed 34167929Deif B, Ballantyne B, Almehmadi F, Mikhail M, McIntyre WF, Manlucu J, Yee R, Sapp JL, Roberts JD, Healey JS, Leong-Sit P, Tang AS. Cardiac resynchronization is pro-arrhythmic in the absence of reverse ventricular remodelling: a systematic review and meta-analysis. Cardiovasc Res. 2018 Sep 1;114(11):1435-1444. doi: 10.1093/cvr/cvy182.
PubMed 30010807Galand V, Singh JP, Leclercq C. Alternative left ventricular pacing approaches for optimal cardiac resynchronization therapy. Heart Rhythm. 2019 Aug;16(8):1281-1289. doi: 10.1016/j.hrthm.2019.03.011. Epub 2019 Mar 16.
PubMed 30885737Duchenne J, Aalen JM, Cvijic M, Larsen CK, Galli E, Bezy S, Beela AS, Unlu S, Pagourelias ED, Winter S, Hopp E, Kongsgard E, Donal E, Fehske W, Smiseth OA, Voigt JU. Acute redistribution of regional left ventricular work by cardiac resynchronization therapy determines long-term remodelling. Eur Heart J Cardiovasc Imaging. 2020 Jun 1;21(6):619-628. doi: 10.1093/ehjci/jeaa003.
PubMed 32031587Cvijic M, Duchenne J, Unlu S, Michalski B, Aarones M, Winter S, Aakhus S, Fehske W, Stankovic I, Voigt JU. Timing of myocardial shortening determines left ventricular regional myocardial work and regional remodelling in hearts with conduction delays. Eur Heart J Cardiovasc Imaging. 2018 Aug 1;19(8):941-949. doi: 10.1093/ehjci/jex325.
PubMed 29272366Abdelrahman M, Subzposh FA, Beer D, Durr B, Naperkowski A, Sun H, Oren JW, Dandamudi G, Vijayaraman P. Clinical Outcomes of His Bundle Pacing Compared to Right Ventricular Pacing. J Am Coll Cardiol. 2018 May 22;71(20):2319-2330. doi: 10.1016/j.jacc.2018.02.048. Epub 2018 Mar 10.
PubMed 29535066Dandamudi G, Vijayaraman P. History of His bundle pacing. J Electrocardiol. 2017 Jan-Feb;50(1):156-160. doi: 10.1016/j.jelectrocard.2016.09.011. Epub 2016 Sep 24.
PubMed 27720211Brugada J, Katritsis DG, Arbelo E, Arribas F, Bax JJ, Blomstrom-Lundqvist C, Calkins H, Corrado D, Deftereos SG, Diller GP, Gomez-Doblas JJ, Gorenek B, Grace A, Ho SY, Kaski JC, Kuck KH, Lambiase PD, Sacher F, Sarquella-Brugada G, Suwalski P, Zaza A; ESC Scientific Document Group. 2019 ESC Guidelines for the management of patients with supraventricular tachycardiaThe Task Force for the management of patients with supraventricular tachycardia of the European Society of Cardiology (ESC). Eur Heart J. 2020 Feb 1;41(5):655-720. doi: 10.1093/eurheartj/ehz467. No abstract available.
PubMed 31504425
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conduction System Pacing Versus Biventricular Pacing for Cardiac ResYNChronization (CSP-SYNC)
- ClinicalTrials.gov ID
- NCT05155865
- Acronym / sponsor ID
- CSP-SYNC / CSP-SYNC
- Conditions
- Dilated Cardiomyopathy with Conduction Defect, Left Bundle-Branch Block, Heart Failure, Resynchronization Therapy, Cardiac Remodeling, Ventricular
- Keywords
- left bundle branch block, dilated cardiomyopathy, resynchronization therapy, myocardial work, arrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 14 Dec 2021 (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.
Cardiac resynchronization therapy (CRT) with biventricular pacing (BiV) is the cornerstone treatment for heart failure patients with ventricular dyssynchrony. Recently, a new concept, conduction system pacing (CSP) with permanent pacing, including His bundle pacing and left bundle branch pacing, has been proposed as a potential alternative to conventional BiV-CRT. The prospective, randomized trial will compare echocardiographic, electrocardiographic, and clinical effects of CSP versus conventional BiV pacing in heart failure patients with reduced ejection fraction (LVEF ≤ 35%), sinus rhythm, and left bundle branch block. Patients will be randomized to either CSP or biventricular pacing study group and followed up for at least 6 months. The study will explore whether CSP is non-inferior to BiV pacing in echocardiographic, electrocardiographic, and clinical outcomes.
Detailed description
Cardiac resynchronization therapy (CRT) with biventricular pacing is an integral part of heart failure therapy in patients with reduced ejection fraction and wide QRS. Previous studies have demonstrated improved quality of life, reduced heart failure hospitalization, and decreased all-cause mortality. However, approx. 30% of patients still do not benefit from this therapy. High pacing thresholds and phrenic nerve stimulation are also common problems with BiV stimulation. Newer CRT systems with improved programmability and algorithms in conjunction with quadripolar left ventricular leads have solved some challenges of BiV pacing. However, BiV stimulation with non-physiological epicardial activation has shown a possible pro-arrhythmic effect which is more pronounced in the non-responder population.
On the other hand, CSP provides synchronous physiological ventricular activation with possible superior electrical and mechanical resynchronization compared to BiV pacing. Electrical activation maps obtained during CSP showed normalization of left bundle branch block with more homogeneous electrical resynchronization than in biventricular pacing. Additionally, BiV CRT effectively corrects mechanical dyssnchrony, demonstrated with homogenization of myocardial work. This has already been proven as the underlying pathophysiological mechanism for successful CRT response. However, the effect of CSP on echocardiographic parameters of mechanical dyssynchrony is not known.
Previous studies of CSP focused on feasibility and its benefits over right ventricular pacing in patients with refractory atrial fibrillation who underwent atrioventricular node ablation and pacemaker implantation. Promising results were followed by the acknowledgment of this physiological mode of pacing by the recent guidelines of European Society of Cardiology. However, studies evaluating the value of CSP as an alternative approach to BiV CRT in heart failure patients are limited. The purpose of this study is to compare the effects of CSP and conventional BiV pacing on electrocardiographic and echocardiographic parameters as well as on clinical outcomes in patients with heart failure with reduced ejection fraction (LVEF ≤35%), sinus rhythm, and left bundle branch block. In this single-center study, 60 patients will be randomized into one of two arms: a BiV pacing arm with BiV CRT implantation based on clinical guidelines or an experimental CSP arm with the implantation of a CSP device. Device with a defibrillator (ICD) will be selected at the discretion of the implanting physician. Baseline and follow up assessments will include clinical evaluation (New York Heart Association class, 6-minute walking distance), evaluation of quality of life (EQ-5D index), laboratory tests (N-terminal pro-B-type natriuretic peptide), electrocardiographic recordings (standard 12-leads ECG and high-resolution-ECG), and echocardiographic evaluation (standard echocardiographic parameters of LV reverse remodeling and non-invasive myocardial work assessment). Intra-operative and procedural parameters will also be recorded.
Investigators hypothesize that CSP could represent a feasible and safe alternative to conventional BiV pacing in terms of clinical, electrocardiographic, and echocardiographic outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resynchronization with conduction system pacing | Experimental | Device: Resynchronization with conduction system pacingImplantation of permanent pacemaker with conduction system pacing (preferably left bundle branch) with or without defibrillator lead placement. Optimal guidelines-based heart failure treatment and antiarrhythmic drugs. |
| Cardiac resynchronization therapy with biventricular stimulation | Active comparator | Device: Cardiac resynchronization therapy with biventricular stimulationImplantation of cardiac resynchronization therapy with biventricular stimulation with or without defibrillator lead placement. Optimal guidelines-based heart failure treatment and antiarrhythmic drugs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The proposed inclusion criteria represent the minimum recommendations for CRT implantation according to the ESC 2021 guidelines. In addition:
- Sinus rhythm and complete left bundle branch block according to Strauss criteria
- LVEF ≤35%
- NYHA class II-III
- Optimal medical heart failure therapy for at least 3 months before enrollment
Key exclusion criteria (9 listed)
- Mechanical tricuspid valve replacement
- More than moderate valvular disease
- Unstable angina, acute MI, CABG, or PCI within the past 6 months
- Persistent or permanent atrial fibrillation
- Ventricular arrhythmias (frequent PVC) which do not allow to acquire consecutive regular beats during echocardiography and electrocardiography
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 |
|---|---|---|
| Resynchronization with conduction system pacingImplantation of permanent pacemaker with conduction system pacing (preferably left bundle branch) with or without defibrillator lead placement | Device | Resynchronization with conduction system pacing |
| Cardiac resynchronization therapy with biventricular stimulationImplantation of cardiac resynchronization therapy with biventricular stimulation with or without defibrillator lead placement | Device | Cardiac resynchronization therapy with biventricular stimulation |
Primary outcome
Change in left ventricular volume
Time frame: acute after the procedure, 1 month, 6 months, 12 months
Effect on reverse left ventricular remodeling measured as changes in left ventricular volume in both arms
Change in left ventricular ejection fraction
Time frame: acute procedure, 1 month, 6 months, 12 months
Effect on reverse left ventricular remodeling measured as changes in left ventricular ejection fraction in both arms
Difference in Heart Failure Class
Time frame: 6 months
From class 1 to 4
Difference in pro-BNP value
Time frame: 6 months
pg/mL
Difference in 6-minute walk test distance
Time frame: 6 months
meters
Difference in the EQ-5D index
Time frame: 6 months
score
7 secondary outcomes
Difference in myocardial work redistribution
Time frame: acute after the procedure, 1 month, 6 months, 12 months
Difference in QRS complex width
Time frame: acute after the procedure, 1 month, 6 months, 12 months
Difference in filtered QRS duration on high-resolution electrocardiogram
Time frame: acute after procedure, 1 month, 6 months, 12 months
Difference in sum absolute QRST integral
Time frame: acute after the procedure, 1 month, 6 months, 12 months
Difference in arrhythmia occurrence
Time frame: at least 12 months after enrollment
Rate of procedural complications
Time frame: at least 12 months after enrollment
Tpeak-end duration
Time frame: acute after the procedure, 1 month, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Background: PubMed 33936744Sharma PS, Vijayaraman P. Conduction System Pacing for Cardiac Resynchronisation. Arrhythm Electrophysiol Rev. 2021 Apr;10(1):51-58. doi: 10.15420/aer.2020.45.
- Background: PubMed 33247913Herweg B, Welter-Frost A, Vijayaraman P. The evolution of cardiac resynchronization therapy and an introduction to conduction system pacing: a conceptual review. Europace. 2021 Apr 6;23(4):496-510. doi: 10.1093/europace/euaa264.
- Background: PubMed 32387225Wu S, Su L, Vijayaraman P, Zheng R, Cai M, Xu L, Shi R, Huang Z, Whinnett ZI, Huang W. Left Bundle Branch Pacing for Cardiac Resynchronization Therapy: Nonrandomized On-Treatment Comparison With His Bundle Pacing and Biventricular Pacing. Can J Cardiol. 2021 Feb;37(2):319-328. doi: 10.1016/j.cjca.2020.04.037. Epub 2020 May 7.
- Background: PubMed 34167929Vinther M, Risum N, Svendsen JH, Mogelvang R, Philbert BT. A Randomized Trial of His Pacing Versus Biventricular Pacing in Symptomatic HF Patients With Left Bundle Branch Block (His-Alternative). JACC Clin Electrophysiol. 2021 Nov;7(11):1422-1432. doi: 10.1016/j.jacep.2021.04.003. Epub 2021 Apr 25.
- Background: PubMed 30010807Deif B, Ballantyne B, Almehmadi F, Mikhail M, McIntyre WF, Manlucu J, Yee R, Sapp JL, Roberts JD, Healey JS, Leong-Sit P, Tang AS. Cardiac resynchronization is pro-arrhythmic in the absence of reverse ventricular remodelling: a systematic review and meta-analysis. Cardiovasc Res. 2018 Sep 1;114(11):1435-1444. doi: 10.1093/cvr/cvy182.
- Background: PubMed 30885737Galand V, Singh JP, Leclercq C. Alternative left ventricular pacing approaches for optimal cardiac resynchronization therapy. Heart Rhythm. 2019 Aug;16(8):1281-1289. doi: 10.1016/j.hrthm.2019.03.011. Epub 2019 Mar 16.
- Background: PubMed 32031587Duchenne J, Aalen JM, Cvijic M, Larsen CK, Galli E, Bezy S, Beela AS, Unlu S, Pagourelias ED, Winter S, Hopp E, Kongsgard E, Donal E, Fehske W, Smiseth OA, Voigt JU. Acute redistribution of regional left ventricular work by cardiac resynchronization therapy determines long-term remodelling. Eur Heart J Cardiovasc Imaging. 2020 Jun 1;21(6):619-628. doi: 10.1093/ehjci/jeaa003.
- Background: PubMed 29272366Cvijic M, Duchenne J, Unlu S, Michalski B, Aarones M, Winter S, Aakhus S, Fehske W, Stankovic I, Voigt JU. Timing of myocardial shortening determines left ventricular regional myocardial work and regional remodelling in hearts with conduction delays. Eur Heart J Cardiovasc Imaging. 2018 Aug 1;19(8):941-949. doi: 10.1093/ehjci/jex325.
- Background: PubMed 29535066Abdelrahman M, Subzposh FA, Beer D, Durr B, Naperkowski A, Sun H, Oren JW, Dandamudi G, Vijayaraman P. Clinical Outcomes of His Bundle Pacing Compared to Right Ventricular Pacing. J Am Coll Cardiol. 2018 May 22;71(20):2319-2330. doi: 10.1016/j.jacc.2018.02.048. Epub 2018 Mar 10.
- Background: PubMed 27720211Dandamudi G, Vijayaraman P. History of His bundle pacing. J Electrocardiol. 2017 Jan-Feb;50(1):156-160. doi: 10.1016/j.jelectrocard.2016.09.011. Epub 2016 Sep 24.
- Background: PubMed 31504425Brugada J, Katritsis DG, Arbelo E, Arribas F, Bax JJ, Blomstrom-Lundqvist C, Calkins H, Corrado D, Deftereos SG, Diller GP, Gomez-Doblas JJ, Gorenek B, Grace A, Ho SY, Kaski JC, Kuck KH, Lambiase PD, Sacher F, Sarquella-Brugada G, Suwalski P, Zaza A; ESC Scientific Document Group. 2019 ESC Guidelines for the management of patients with supraventricular tachycardiaThe Task Force for the management of patients with supraventricular tachycardia of the European Society of Cardiology (ESC). Eur Heart J. 2020 Feb 1;41(5):655-720. doi: 10.1093/eurheartj/ehz467. No abstract available.
- Individual participant dataSharing planned: Yes
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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.
Marta Cvijc, MD study chair
University Medical Centre Ljubljana (Slovenia)
Anja Zupan Meznar, MD study chair
University Medical Centre Ljubljana (Slovenia)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resynchronization with conduction system pacing and Cardiac resynchronization therapy with biventricular stimulation in people with Dilated Cardiomyopathy with Conduction Defect and Left Bundle-Branch Block, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 7 inclusion and 9 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 1 Nov 2024. 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 Slovenia. 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?
Change in left ventricular volume (time frame: acute after the procedure, 1 month, 6 months, 12 months). The study lists 6 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 NCT05155865, which also lists 11 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 1 Nov 2024.