Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI
NCT ID: NCT05966675
Last Updated: 2025-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
500 participants
INTERVENTIONAL
2024-02-27
2028-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pacemaker Utilization and Ventricular Pacing in Patients Undergoing Trans-catheter Aortic Valve Replacement (TAVR)
NCT02994667
Effects of Left Ventricular Pacing Optimilization on Cardiac Perfusion, Contractile Force, and Clinical Performance in Patients With Ventricular Dysfunction and Heart Failure
NCT00551681
Ventricular Pacing Rate in Follow-up of Patients Treated With Definitive PM Implantation Post TAVI
NCT06499428
Conventional Biventricular Versus Left Bundle Branch Pacing on Outcomes in Heart Failure Patients
NCT05769036
Electrophysiologic HV-interval as a Predicor for Permanent Pacemaker Implantation After TAVI
NCT01801098
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Conduction System Pacing
Patients who receive Conduction System Pacing in form of Left Bundle Branch Area Pacing or His Bundle Pacing.
conduction system pacing
Implantation of cardiac implantable electronic device (CIED) with conduction system pacing (left bundle branch area pacing or his bundle pacing).
Standard Pacing Method
Patients who receive currently standard pacing method with exact type of ventricular pacing depending upon left ventricular ejection fraction (LVEF): right ventricular pacing in case of LVEF \>= 40% or biventricular pacing if LVEF is determined to be less than 40%, as per current ESC guidelines.
right ventricular or biventricular pacing
Implantation of cardiac implantable electronic device with right ventricular or biventricular pacing according to left ventricular ejection fraction and current ESC guidelines.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
conduction system pacing
Implantation of cardiac implantable electronic device (CIED) with conduction system pacing (left bundle branch area pacing or his bundle pacing).
right ventricular or biventricular pacing
Implantation of cardiac implantable electronic device with right ventricular or biventricular pacing according to left ventricular ejection fraction and current ESC guidelines.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Fulfilled criteria for permanent pacemaker implantation according do 2021 ESC guidelines
3. Written informed consent
4. Age of at least 18 years
Exclusion Criteria
2. The occurrence of conduction disturbances more than 30 days after TAVI procedure
3. No written informed consent
4. Inability to obtain informed consent from participant
5. Predicted inability to obtain cooperation from patient during observation period
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical Research Agency, Poland
OTHER_GOV
Medical University of Silesia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Krzysztof S. Gołba, MD PhD
Role: STUDY_CHAIR
Silesian Medical University in Katowice
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University of Silesia in Katowice
Katowice, , Poland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. No abstract available.
Shimony A, Eisenberg MJ, Filion KB, Amit G. Beneficial effects of right ventricular non-apical vs. apical pacing: a systematic review and meta-analysis of randomized-controlled trials. Europace. 2012 Jan;14(1):81-91. doi: 10.1093/europace/eur240. Epub 2011 Jul 27.
Daubert JC, Ritter P, Le Breton H, Gras D, Leclercq C, Lazarus A, Mugica J, Mabo P, Cazeau S. Permanent left ventricular pacing with transvenous leads inserted into the coronary veins. Pacing Clin Electrophysiol. 1998 Jan;21(1 Pt 2):239-45. doi: 10.1111/j.1540-8159.1998.tb01096.x.
Dandamudi G, Vijayaraman P. How to perform permanent His bundle pacing in routine clinical practice. Heart Rhythm. 2016 Jun;13(6):1362-6. doi: 10.1016/j.hrthm.2016.03.040. Epub 2016 Mar 22. No abstract available.
Huang W, Chen X, Su L, Wu S, Xia X, Vijayaraman P. A beginner's guide to permanent left bundle branch pacing. Heart Rhythm. 2019 Dec;16(12):1791-1796. doi: 10.1016/j.hrthm.2019.06.016. Epub 2019 Jun 22. No abstract available.
Jastrzebski M, Moskal P, Bednarek A, Kielbasa G, Vijayaraman P, Czarnecka D. Programmed His Bundle Pacing: A Novel Maneuver for the Diagnosis of His Bundle Capture. Circ Arrhythm Electrophysiol. 2019 Feb;12(2):e007052. doi: 10.1161/CIRCEP.118.007052.
Jastrzebski M, Moskal P, Bednarek A, Kielbasa G, Kusiak A, Sondej T, Bednarski A, Vijayaraman P, Czarnecka D. Programmed deep septal stimulation: A novel maneuver for the diagnosis of left bundle branch capture during permanent pacing. J Cardiovasc Electrophysiol. 2020 Feb;31(2):485-493. doi: 10.1111/jce.14352. Epub 2020 Jan 20.
Nazif TM, Dizon JM, Hahn RT, Xu K, Babaliaros V, Douglas PS, El-Chami MF, Herrmann HC, Mack M, Makkar RR, Miller DC, Pichard A, Tuzcu EM, Szeto WY, Webb JG, Moses JW, Smith CR, Williams MR, Leon MB, Kodali SK; PARTNER Publications Office. Predictors and clinical outcomes of permanent pacemaker implantation after transcatheter aortic valve replacement: the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry. JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):60-9. doi: 10.1016/j.jcin.2014.07.022.
Xi Z, Liu T, Liang J, Zhou YJ, Liu W. Impact of postprocedural permanent pacemaker implantation on clinical outcomes after transcatheter aortic valve replacement: a systematic review and meta-analysis. J Thorac Dis. 2019 Dec;11(12):5130-5139. doi: 10.21037/jtd.2019.12.02.
Xu S, Zhang E, Qian Z, Sun J, Zou F, Wang Y, Hou X, Zou J. Mid- to Long-Term Clinical and Echocardiographic Effects of Post-procedural Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis. Front Cardiovasc Med. 2022 Jun 28;9:911234. doi: 10.3389/fcvm.2022.911234. eCollection 2022.
Fadahunsi OO, Olowoyeye A, Ukaigwe A, Li Z, Vora AN, Vemulapalli S, Elgin E, Donato A. Incidence, Predictors, and Outcomes of Permanent Pacemaker Implantation Following Transcatheter Aortic Valve Replacement: Analysis From the U.S. Society of Thoracic Surgeons/American College of Cardiology TVT Registry. JACC Cardiovasc Interv. 2016 Nov 14;9(21):2189-2199. doi: 10.1016/j.jcin.2016.07.026.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022/ABM/03/00049
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.