Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI

NCT05966675 | Recruiting DMC

• 1 other identifier: 2022/ABM/03/00049
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Atrioventricular Block, Second and Third Degree

Keywords

Pacemaker; Transcatheter Aortic Valve Replacement; Conduction System Pacing (CSP); Atrioventricular Block; Congestive Heart Failure; Bradycardia

Outcome Measures

Primary Outcomes (2)

• Heart Failure Hospitalization

  Hospitalization due to heart failure as a main reason

  12 months

• All-cause death

  Death from any cause

  12 months

Secondary Outcomes (8)

• Change in exercise capacity

  24 months

• Response to Cardiac Resynchronization Therapy (CRT)

  24 months

• Pacing-Induced Cardiomyopathy (PICM)

  24 months

• Change in global longitudinal strain (GLS)

  24 months

• Atrial Fibrillation (AF) episodes

  24 months

Study Arms (2)

Conduction System Pacing

EXPERIMENTAL

Patients who receive Conduction System Pacing in form of Left Bundle Branch Area Pacing or His Bundle Pacing.

Device: conduction system pacing

Standard Pacing Method

ACTIVE COMPARATOR

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.

Device: right ventricular or biventricular pacing

Interventions

conduction system pacing DEVICE

Implantation of cardiac implantable electronic device (CIED) with conduction system pacing (left bundle branch area pacing or his bundle pacing).

Conduction System Pacing

right ventricular or biventricular pacing DEVICE

Implantation of cardiac implantable electronic device with right ventricular or biventricular pacing according to left ventricular ejection fraction and current ESC guidelines.

Standard Pacing Method

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• transcatheter aortic valve implantation (TAVI) in up to 30 days before qualification to pacemaker implantation
• Fulfilled criteria for permanent pacemaker implantation according do 2021 ESC guidelines
• Written informed consent
• Age of at least 18 years

You may not qualify if:

• Permanent pacemaker implantation before TAVI procedure
• The occurrence of conduction disturbances more than 30 days after TAVI procedure
• No written informed consent
• Inability to obtain informed consent from participant
• Predicted inability to obtain cooperation from patient during observation period

Sponsors & Collaborators

• Medical University of Silesia: lead
• Medical Research Agency, Poland: collaborator

Study Sites (1)

Medical University of Silesia in Katowice

Katowice, Poland

RECRUITING

Related Publications (11)

• 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.

  PMID: 34455430 BACKGROUND

• 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.

  PMID: 21798880 BACKGROUND

• 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.

  PMID: 9474680 BACKGROUND

• 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.

  PMID: 27016475 BACKGROUND

• 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.

  PMID: 31233818 BACKGROUND

• 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.

  PMID: 30707037 BACKGROUND

• 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.

  PMID: 31930753 BACKGROUND

• 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.

  PMID: 25616819 BACKGROUND

• 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.

  PMID: 32030230 BACKGROUND

• 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.

  PMID: 35837611 BACKGROUND

• 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.

  PMID: 27832844 BACKGROUND

MeSH Terms

Conditions

Atrioventricular Block; Neoplasm Metastasis; Heart Failure; Bradycardia

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Krzysztof S. Gołba, MD PhD

  Silesian Medical University in Katowice

  STUDY CHAIR

Central Study Contacts

Krzysztof S. Gołba, MD PhD

CONTACT

+48 (32)359-88-93; krzysztof.golba@gmail.com

Tomasz Soral, MD

CONTACT

tomasz.soral@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient will be blind to type of intervention. Due to a need of method-specific use of hardware and tailored programming of cardiac devices, medical staff is impossible to blind. The inability to blind affects also echocardiographists and anyone performing device interrogation as significant differences in number and localisation of pacing leads, their electrical parameters and pacemaker settings are inherently different in studied arms.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized 1:1 to the intervention and control groups. In the control group, the type of ventricular pacing will depend on the left ventricular ejection fraction (LVEF): 1) RVP is planned in the group of patients with LVEF ≥40%, 2) BVP is planned in the group of patients with LVEF \<40%, following current ESC guidelines.

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 1, 2023
• Study Start: February 27, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)