Clinical trial · Interventional
Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI
Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post Transcatheter Aortic Valve Implantation
NCT05966675CI-TRIAL-00090763PACE-4-TAVIrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study aims to compare permanent Conduction System Pacing (CSP) with the standard therapy - Right Ventricular Pacing (RVP) or Biventricular Pacing (BVP) - in preventing the development and progression of symptomatic Chronic Heart Failure (CHF) and improving survival in patients after Transcatheter Aortic Valve Implantation (TAVI).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atrioventricular Block, Second and Third Degree | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conduction system pacing | Device | — | UNRESOLVED |
| right ventricular or biventricular pacing | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Conduction System Pacing
- description
- Patients who receive Conduction System Pacing in form of Left Bundle Branch Area Pacing or His Bundle Pacing.
- interventionNames
- Device: conduction system pacing
- type
- ACTIVE_COMPARATOR
- label
- Standard Pacing Method
- description
- 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.
- interventionNames
- Device: right ventricular or biventricular pacing
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. transcatheter aortic valve implantation (TAVI) in up to 30 days before qualification to pacemaker implantation 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: 1. Permanent pacemaker implantation before TAVI procedure 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
References
Publications (11)
- BACKGROUNDGlikson 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. PMID 34455430
- BACKGROUNDShimony 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. PMID 21798880
- BACKGROUNDDaubert 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. PMID 9474680
- BACKGROUNDDandamudi 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. PMID 27016475
- BACKGROUNDHuang 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. PMID 31233818
- BACKGROUNDJastrzebski 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. PMID 30707037