Atrial fibrillation ablation versus heart rate control using conduction system pacing with ablation of the atrioventricular node
| ISRCTN | ISRCTN65526476 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65526476 |
| ClinicalTrials.gov number | NCT06207383 |
| Secondary identifying numbers | SNF_2024-D0031 |
- Submission date
- 25/07/2024
- Registration date
- 05/08/2024
- Last edited
- 06/11/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Atrial fibrillation (AF) impacts heart function by causing a loss of contraction and deteriorating pump function due to the irregular and often rapid heart rate. The coexistence of AF with heart failure (HF) increases the risk of hospitalization and death. Treatment strategies involve drugs to slow down heart rate or to maintain normal rhythm, catheter intervention to maintain normal rhythm (AF ablation by pulmonary vein isolation), or implantation of a pacemaker with catheter ablation of the atrioventricular node (AVNA) to allow the pacemaker to regulate the heart rate. Conduction system pacing (CSP) involves implanting the pacemaker lead directly into the heart's natural electrical conduction system, maintaining a close to normal contraction of the heart (which allows preservation of pump function).
This study evaluates a strategy of AF ablation against CSP combined with AVNA in patients with AF and HF, as these treatments have never been directly compared. The aim is to determine whether CSP with AVNA has similar rates of heart failure hospitalization and death compared to AF ablation.
Who can participate?
Patients aged 60 years and over who have persistent AF (which is continuously present for over 7 days) and HF (with at least one hospitalization or emergency room / HF clinic visit for HF in the past 2 years and elevated blood markers for HF during this interval)
What does the study involve?
Patients are randomly allocated to either AF ablation or to pacemaker implantation with CSP and AVNA. Both these treatments are performed in routine clinical practice. The patients are then followed up for at least 1 year for clinical events (hospitalizations, deaths), as well as other criteria such as quality of life.
What are the possible benefits and risks of participating?
Participants will be closely followed up. The risks involved are those of the routine procedures of the study.
Where is the study run from?
University Hospital of Geneva (Switzerland)
When is the study starting and how long is it expected to run for?
August 2022 to October 2028
Who is funding the study?
Swiss National Science Fund (Switzerland)
Who is the main contact?
Prof. Haran Burri, haran.burri@hug.ch
Contact information
Public, Scientific, Principal Investigator
Cardiology Departement
University Hospital of Geneva
Rue Gabrielle Perret Gentil 4
Geneva
1211
Switzerland
 ORCID ID |
0000-0002-4393-5338 |
|---|---|
| Phone | +41 (0)22 372 72 00 |
| haran.burri@hug.ch |
Study information
| Study design | Investigator-initiated prospective randomized controlled open-label multicentre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Catheter ABlation of Atrial fibrillation versus atrioventricular nodal ablation with CondUction System pacing in persistent atrial fibrillation and heart failure (ABACUS) |
| Study acronym | ABACUS |
| Study hypothesis | The investigation seeks primarily to determine whether Conduction System Pacing + Atrioventricular Nodal Ablation (CSP+AVNA) is superior to atrial fibrillation (AF) ablation to reduce the incidence of cardiovascular hospitalization (CVH) or mortality, and whether it is non-inferior to reduce heart failure hospitalization (HFH) or mortality, in patients with persistent atrial fibrillation (AF) and heart failure (HF). |
| Ethics approval(s) |
1. Approved 16/10/2024, Commission cantonale d'éthique de la recherche (CCER) / Cantonal research ethics commission (Rue Adrien-Lachenal 8, Geneva, 1227, Switzerland; +41 (0)22 546 51 01; ccer@etat.ge.ch), ref: 2024-D0031 2. Approved 26/06/2024, HUS Regional Medical Research Ethics Committee (HUS Central Archives, PO Box 200, Marjaniementie 74, Iiris Centre, Helsinki, 00029 HUS, Finland; -; keskuskirjaamo@hus.fi), ref: HUS/4385/2024 |
| Condition | Persistent atrial fibrillation and heart failure |
| Intervention | AF ablation is a routine procedure and may be performed according to the operator’s preference (e.g. radiofrequency ablation, cryoablation, pulsed-field ablation etc) but should include pulmonary vein isolation (PVI) and restoration of sinus rhythm as a goal. Patients may be included in the trial if they have had a single previous PVI, but any further redo procedures during the course of the trial are considered CVH endpoints. Rate and/or rhythm control medical therapy may be continued after the ablation procedure, as deemed necessary. Randomization will be 1:1 using RedCAP with the alternative intervention of CSP + AVNA. CSP implantation with His bundle pacing (HBP) or left bundle branch area pacing (LBBAP) is currently available in routine clinical practice and may be performed according to the operator’s preference but should include conduction system capture or left ventricular septal pacing (LVSP) as a goal. All hardware to be used are commercially available and some will soon receive regulatory approval for CSP. AVNA is a standard procedure which may be performed during the implantation or as a staged procedure, according to operator preference. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The following primary endpoints are assessed at the last follow-up/study closure: 1. The composite of all-cause death and CVH (superiority hypothesis) 2. The composite of all-cause death and HFH (non-inferiority hypothesis) |
| Secondary outcome measures | The following secondary endpoints are measured using patient medical records at the last follow-up/study closure unless specified otherwise: 1. Individual components of the primary endpoints 2. Cardiovascular mortality 3. Duration of hospitalization for cardiovascular causes 4. Reintervention rate (atrial fibrillation [AF] ablation or device-related) 6. Need for pacemaker implantation (e.g. sinus node dysfunction following AF ablation) 7. Atrioventricular nodal ablation (AVNA) or AF ablation crossovers 8. Sinus rhythm at each follow-up 9. New York Heart Association (NYHA) class at baseline, 1 year and at end of follow-up 10. Quality of life (QOL) questionnaire measured using the Minnesota Living with Heart Failure and EQ-5D-5L at baseline and 1-year 11. Symptom classification for AF measured using the modified European Heart Rhythm Association (EHRA) score 12. Patient-reported outcome measures (PROMs) at 1 year 13. Win ratio composite endpoint analysis 14. Left ventricular ejection fraction (LVEF) at 1 year 15. Left atrial size at 1 year (long axis diameter and 4-chamber surface area) 16. Periprocedural complications (within 1 month of intervention) 17. Long-term complications 18. Healthcare costs and cost-effectiveness |
| Overall study start date | 16/08/2022 |
| Overall study end date | 01/10/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 60 Years |
| Upper age limit | 100 Years |
| Sex | Male |
| Target number of participants | 220 |
| Participant inclusion criteria | 1. Persistent AF with symptomatic HF despite medical therapy, considered to be suitable for AF ablation, with at most one previous PVI procedure 2. At least one prior hospital admission, or emergency room / HF clinic visit for HF in the past 2 years, with NT-pro-BNP >1000 pg/ml or BNP >250 pg/ml measured at any timepoint during this interval 3. Previous or current rate or rhythm control drug therapy 4. Considered eligible for CSP implantation as an alternative to AF ablation 5. Age > or = 60 years |
| Participant exclusion criteria | 1. NYHA Class IV and systolic blood pressure ≤80 mmHg despite optimized therapy 2. Life expectancy <2 years 3. Need for major surgical intervention 4. Myocardial infarction, stroke or percutaneous coronary intervention within the previous 3 months 5. Previously implanted or planned implantation of CRT device or pacemaker. Implantable cardioverter defibrillator (ICD) implantation without a pacing indication is acceptable. 6. Participation in another controlled trial 7. Inability to sign an informed consent form |
| Recruitment start date | 24/10/2024 |
| Recruitment end date | 20/08/2027 |
Locations
Countries of recruitment
- Austria
- Belgium
- Bulgaria
- Czech Republic
- England
- Finland
- France
- Germany
- Hungary
- Italy
- Netherlands
- Poland
- Spain
- Switzerland
- United Kingdom
Study participating centres
Geneva
1211
Switzerland
Bern
3010
Switzerland
Zurich
8091
Switzerland
Basel
4031
Switzerland
Bologna
40138
Italy
Rovigo
45100
Italy
Novara
28100
Italy
Cona
8-44124
Italy
Leipzig
04289
Germany
Bad Oeynhausen
32545
Germany
Bremen
28277
Germany
Valencia
46026
Spain
Barcelona
08036
Spain
Zaragoza
50009
Spain
Madrid
28046
Spain
Prag
100 00
Czech Republic
Budapest
1085
Hungary
Edegem
2650
Belgium
Gent
9000
Belgium
Bruges
8000
Belgium
Krakow
30-688
Poland
Rzeszów
35-623
Poland
Helsinki
FI-00029
Finland
Linz
4020
Austria
Graz
8036
Austria
Sofia
1407
Bulgaria
Maastricht
6229
Netherlands
London
SW3 6LY
United Kingdom
Rouen
76031
France
Sponsor information
Hospital/treatment centre
Mrs Delphine Nerfin, University Hospital of Geneva, Legal Affairs Department, Bvd de la Cluse 77 - 1211 Genève 14
Geneva
1211
Switzerland
| Phone | +41 (0)79 553 17 59 |
|---|---|
| haran.burri@hug.ch | |
| Website | http://www.hug-ge.ch/ |
"ROR" |
https://ror.org/01m1pv723 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Schweizerischer Nationalfonds, Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerische Nationalfonds, SNF, SNSF, FNS
- Location
- Switzerland
Results and Publications
| Intention to publish date | 30/01/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Presentation of the results in a cardiology congress (EHRA) and publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository (Yareta) without personal data identifiers. |
Editorial Notes
06/11/2024: The recruitment start date was changed from 01/09/2024 to 24/10/2024.
05/11/2024: Ethics approval details added.
05/08/2024: Study's existence confirmed by the Swiss National Science Foundation.
