Prophylactic Permanent Pacemaker in Patients With Right Bundle Branch Block Undergoing Transcatheter Aortic Valve Implantation

NCT05889208 | Not Yet Recruiting DMC

• 1 other identifier: TAVI-PACE
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn about the safety and outcome of prophylactic pacemaker implantation in patients with right bundle-branch block undergoing trans-catheter aortic valve (TAVI) implantation in patients with severe aortic stenosis and left ventricular ejection fraction.Participants will be randomized to:

• Prophylactic pacemaker implantation prior TAVI
• Conservative strategy

Conditions

Aortic Stenosis; Right Bundle-Branch Block

Keywords

Trans-catheter aortic valve implantation; Pacemaker

Outcome Measures

Primary Outcomes (1)

• Events in the control arm

  Composite of all-cause mortality, unplanned pacemaker implantation and new onset of heart failure

  12 months

Study Arms (2)

Prophylactic pacemaker implantation

ACTIVE COMPARATOR

Brady-pacemaker implantation prior the TAVI-procedure. Pacemaker modus is according to local conditions.

Device: Prophylactic pacemaker implantation

Usual care

NO INTERVENTION

Pacemaker implantation after TAVI if atrioventricular block occurs.

Interventions

Prophylactic pacemaker implantation DEVICE

Pacemaker implantation prior the TAVI-procedure

Prophylactic pacemaker implantation

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients undergoing TAVI indicated by severe valvular aortic stenosis
• Written informed consent
• Left ventricular ejection fraction ≥ 40 %
• Persistent RBBB in 12-lead electrocardiogram (RSR' pattern in V1-3, QRS duration \> 120 milliseconds, and wide S wave in leads I, aVL, V5-6)

You may not qualify if:

• Other indications for pacemaker implantation or previously implanted pacemaker
• Life expectancy \< 1 year
• No written informed consent

Sponsors & Collaborators

• Aalborg University Hospital: lead

Related Publications (10)

• Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available.

  PMID: 34453165 BACKGROUND

• Suh SH, Oh TR, Choi HS, Yang EM, Kim CS, Bae EH, Ma SK, Oh KH, Hyun YY, Sung S, Kim SW; Korean Cohort Study for Outcomes in Patients with Chronic Kidney Disease (KNOW-CKD) Investigators. Bone Mineral Density and All-Cause Mortality in Patients with Nondialysis Chronic Kidney Disease: Results from KNOW-CKD Study. J Clin Med. 2023 Feb 25;12(5):1850. doi: 10.3390/jcm12051850.

  PMID: 36902637 BACKGROUND

• van Rosendael PJ, Delgado V, Bax JJ. Pacemaker implantation rate after transcatheter aortic valve implantation with early and new-generation devices: a systematic review. Eur Heart J. 2018 Jun 1;39(21):2003-2013. doi: 10.1093/eurheartj/ehx785.

  PMID: 29420704 BACKGROUND

• Maeno Y, Abramowitz Y, Kawamori H, Kazuno Y, Kubo S, Takahashi N, Mangat G, Okuyama K, Kashif M, Chakravarty T, Nakamura M, Cheng W, Friedman J, Berman D, Makkar RR, Jilaihawi H. A Highly Predictive Risk Model for Pacemaker Implantation After TAVR. JACC Cardiovasc Imaging. 2017 Oct;10(10 Pt A):1139-1147. doi: 10.1016/j.jcmg.2016.11.020. Epub 2017 Apr 12.

  PMID: 28412434 BACKGROUND

• Auffret V, Webb JG, Eltchaninoff H, Munoz-Garcia AJ, Himbert D, Tamburino C, Nombela-Franco L, Nietlispach F, Moris C, Ruel M, Dager AE, Serra V, Cheema AN, Amat-Santos IJ, de Brito FS Jr, Lemos PA, Abizaid A, Sarmento-Leite R, Dumont E, Barbanti M, Durand E, Alonso Briales JH, Vahanian A, Bouleti C, Imme S, Maisano F, Del Valle R, Benitez LM, Garcia Del Blanco B, Puri R, Philippon F, Urena M, Rodes-Cabau J. Clinical Impact of Baseline Right Bundle Branch Block in Patients Undergoing Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2017 Aug 14;10(15):1564-1574. doi: 10.1016/j.jcin.2017.05.030. Epub 2017 Jul 19.

  PMID: 28734885 BACKGROUND

• Watanabe Y, Kozuma K, Hioki H, Kawashima H, Nara Y, Kataoka A, Nagura F, Nakashima M, Shirai S, Tada N, Araki M, Takagi K, Yamanaka F, Yamamoto M, Hayashida K. Pre-Existing Right Bundle Branch Block Increases Risk for Death After Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve. JACC Cardiovasc Interv. 2016 Nov 14;9(21):2210-2216. doi: 10.1016/j.jcin.2016.08.035.

  PMID: 27832846 BACKGROUND

• 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

• Nielsen JC, Andersen HR, Thomsen PE, Thuesen L, Mortensen PT, Vesterlund T, Pedersen AK. Heart failure and echocardiographic changes during long-term follow-up of patients with sick sinus syndrome randomized to single-chamber atrial or ventricular pacing. Circulation. 1998 Mar 17;97(10):987-95. doi: 10.1161/01.cir.97.10.987.

  PMID: 9529267 BACKGROUND

• Okuno T, Asami M, Heg D, Lanz J, Praz F, Hagemeyer D, Brugger N, Grani C, Huber A, Spirito A, Raber L, Stortecky S, Windecker S, Pilgrim T. Impact of Left Ventricular Outflow Tract Calcification on Procedural Outcomes After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2020 Aug 10;13(15):1789-1799. doi: 10.1016/j.jcin.2020.04.015.

  PMID: 32763071 BACKGROUND

• Bisson A, Bodin A, Herbert J, Lacour T, Saint Etienne C, Pierre B, Clementy N, Deharo P, Babuty D, Fauchier L. Pacemaker Implantation After Balloon- or Self-Expandable Transcatheter Aortic Valve Replacement in Patients With Aortic Stenosis. J Am Heart Assoc. 2020 May 5;9(9):e015896. doi: 10.1161/JAHA.120.015896. Epub 2020 May 2.

  PMID: 32362220 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis; Bundle-Branch Block

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Heart Block; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ashkan Eftekhari

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashkan Eftekhari, MD PhD

CONTACT

+4597664465; asef@rn.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant ass. professor MD PhD

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 5, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 5, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE