Heart Failure Clinical Trial
— CONDUCT-AFOfficial title:
CONDUCTion System Pacing Versus Biventricular Pacing After Atrioventricular Node Ablation in Heart Failure Patients With Symptomatic Atrial Fibrillation and Narrow QRS (CONDUCT-AF Trial)
Atrioventricular node ablation (AVNA) with biventricular (BiV) pacemaker implantation is a feasible treatment option in patients with symptomatic refractory atrial fibrillation and heart failure. However, conduction system pacing (CSP) modalities, including His bundle pacing and left bundle branch pacing, could offer advantages over BiV pacing by providing more physiological activation. The randomized, interventional, multicentric study will explore whether CSP is non-inferior to BiV pacing in echocardiographic and clinical outcomes in heart failure (EF <50%) patients with symptomatic AF and narrow QRS scheduled for AVNA.
Status | Recruiting |
Enrollment | 82 |
Est. completion date | December 25, 2026 |
Est. primary completion date | December 25, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: 1. Symptomatic permanent atrial fibrillation, refractory to drug therapy or failed catheter ablation 2. Left ventricular ejection fraction <50% 3. Narrow intrinsic QRS = 120 ms 4. NT-proBNP > 600 ng/L 5. Patient has provided written informed consent 6. Age between 18 years and 85 years Exclusion Criteria: 1. Pre-existing permanent pacemaker, implantable cardioverter-defibrillator or cardiac resynchronization device. Patients who had devices implanted that had <5% of paced beats (i.e., backup pacing) can be enrolled. 2. Life expectancy less than 12 months 3. Severe concomitant non-cardiac disease 4. Pregnancy 5. Recent (<3 months) myocardial infarction, percutaneous or surgical myocardial revascularization 6. Significant heart valve disease (severe insufficiency or stenosis) 7. Contraindication for oral anticoagulation 8. Mechanical tricuspid valve replacement 9. Unwillingness to participate or lack of availability for follow-up |
Country | Name | City | State |
---|---|---|---|
Austria | University Hospital Graz - Divison of Cardiology | Graz | |
Belgium | Hospital Oost-Limburg (Hartzentrum Genk) | Genk | |
Bulgaria | Acibadem City Clinic Tokuda Hospital - Department of Invasive Electrophysiology | Sofia | |
Croatia | Clinical Hospital Center Rijeka | Rijeka | |
Croatia | University Hospital of Split | Split | |
Croatia | University Hospital Centre Zagreb | Zagreb | |
Romania | County Clinical emergency hospital of Brasov - Department of Interventional Cardiology | Brasov | |
Slovenia | University Medical Centre Ljubljana - Department of cardiology | Ljubljana | |
Slovenia | University Medical Centre Ljubljana - Department of cardiovascular surgery | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
University Medical Centre Ljubljana |
Austria, Belgium, Bulgaria, Croatia, Romania, Slovenia,
Brignole M, Pentimalli F, Palmisano P, Landolina M, Quartieri F, Occhetta E, Calo L, Mascia G, Mont L, Vernooy K, van Dijk V, Allaart C, Fauchier L, Gasparini M, Parati G, Soranna D, Rienstra M, Van Gelder IC; APAF-CRT Trial Investigators. AV junction ablation and cardiac resynchronization for patients with permanent atrial fibrillation and narrow QRS: the APAF-CRT mortality trial. Eur Heart J. 2021 Dec 7;42(46):4731-4739. doi: 10.1093/eurheartj/ehab569. Erratum In: Eur Heart J. 2021 Oct 16;: Eur Heart J. 2021 Dec 08;: — View Citation
Brugada J, Katritsis DG, Arbelo E, Arribas F, Bax JJ, Blomstrom-Lundqvist C, Calkins H, Corrado D, Deftereos SG, Diller GP, Gomez-Doblas JJ, Gorenek B, Grace A, Ho SY, Kaski JC, Kuck KH, Lambiase PD, Sacher F, Sarquella-Brugada G, Suwalski P, Zaza A; ESC Scientific Document Group. 2019 ESC Guidelines for the management of patients with supraventricular tachycardiaThe Task Force for the management of patients with supraventricular tachycardia of the European Society of Cardiology (ESC). Eur Heart J. 2020 Feb 1;41(5):655-720. doi: 10.1093/eurheartj/ehz467. No abstract available. Erratum In: Eur Heart J. 2020 Nov 21;41(44):4258. — View Citation
Chatterjee NA, Upadhyay GA, Ellenbogen KA, Hayes DL, Singh JP. Atrioventricular nodal ablation in atrial fibrillation: a meta-analysis of biventricular vs. right ventricular pacing mode. Eur J Heart Fail. 2012 Jun;14(6):661-7. doi: 10.1093/eurjhf/hfs036. Epub 2012 Mar 21. — View Citation
Huang W, Su L, Wu S, Xu L, Xiao F, Zhou X, Ellenbogen KA. Benefits of Permanent His Bundle Pacing Combined With Atrioventricular Node Ablation in Atrial Fibrillation Patients With Heart Failure With Both Preserved and Reduced Left Ventricular Ejection Fraction. J Am Heart Assoc. 2017 Apr 1;6(4):e005309. doi: 10.1161/JAHA.116.005309. — View Citation
Ivanovski M, Mrak M, Meznar AZ, Zizek D. Biventricular versus Conduction System Pacing after Atrioventricular Node Ablation in Heart Failure Patients with Atrial Fibrillation. J Cardiovasc Dev Dis. 2022 Jul 1;9(7):209. doi: 10.3390/jcdd9070209. — View Citation
Muthumala A, Vijayaraman P. His-Purkinje conduction system pacing and atrioventricular node ablation. Herzschrittmacherther Elektrophysiol. 2020 Jun;31(2):117-123. doi: 10.1007/s00399-020-00679-7. Epub 2020 May 6. — View Citation
Orlov MV, Gardin JM, Slawsky M, Bess RL, Cohen G, Bailey W, Plumb V, Flathmann H, de Metz K. Biventricular pacing improves cardiac function and prevents further left atrial remodeling in patients with symptomatic atrial fibrillation after atrioventricular node ablation. Am Heart J. 2010 Feb;159(2):264-70. doi: 10.1016/j.ahj.2009.11.012. — View Citation
Pillai A, Kolominsky J, Koneru JN, Kron J, Shepard RK, Kalahasty G, Huang W, Verma A, Ellenbogen KA. Atrioventricular junction ablation in patients with conduction system pacing leads: A comparison of His-bundle vs left bundle branch area pacing leads. Heart Rhythm. 2022 Jul;19(7):1116-1123. doi: 10.1016/j.hrthm.2022.03.1222. Epub 2022 Mar 26. — View Citation
Su L, Cai M, Wu S, Wang S, Xu T, Vijayaraman P, Huang W. Long-term performance and risk factors analysis after permanent His-bundle pacing and atrioventricular node ablation in patients with atrial fibrillation and heart failure. Europace. 2020 Dec 26;22(Suppl_2):ii19-ii26. doi: 10.1093/europace/euaa306. — View Citation
Tan ES, Rienstra M, Wiesfeld AC, Schoonderwoerd BA, Hobbel HH, Van Gelder IC. Long-term outcome of the atrioventricular node ablation and pacemaker implantation for symptomatic refractory atrial fibrillation. Europace. 2008 Apr;10(4):412-8. doi: 10.1093/europace/eun020. Epub 2008 Feb 12. — View Citation
Wang S, Wu S, Xu L, Xiao F, Whinnett ZI, Vijayaraman P, Su L, Huang W. Feasibility and Efficacy of His Bundle Pacing or Left Bundle Pacing Combined With Atrioventricular Node Ablation in Patients With Persistent Atrial Fibrillation and Implantable Cardioverter-Defibrillator Therapy. J Am Heart Assoc. 2019 Dec 17;8(24):e014253. doi: 10.1161/JAHA.119.014253. Epub 2019 Dec 13. — View Citation
Zizek D, Antolic B, Meznar AZ, Zavrl-Dzananovic D, Jan M, Stublar J, Pernat A. Biventricular versus His bundle pacing after atrioventricular node ablation in heart failure patients with narrow QRS. Acta Cardiol. 2022 May;77(3):222-230. doi: 10.1080/00015385.2021.1903196. Epub 2021 Jun 2. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in left ventricular ejection fraction. | Simpson's method assessed with echo. | baseline and 6 months | |
Secondary | Time to the first occurrence of heart failure hospitalization or cardiovascular death. | An episode of heart failure that requires unplanned medical attention with increase of diuretic dose / intravenous diuretic therapy or death due to cardiovascular causes. | at least 24 months | |
Secondary | Time to the first occurrence of heart failure hospitalization. | An episode of heart failure that requires unplanned medical attention with increase of diuretic dose or intravenous diuretic therapy. | at least 24 months | |
Secondary | Time to cardiovascular death. | Death due to cardiovascular causes. | at least 24 months | |
Secondary | Number of heart failure hospitalizations. | Episodes of heart failure that require unplanned medical attention with increase of diuretic dose or intravenous diuretic therapy. | at least 24 months | |
Secondary | Change in LV end-diastolic and end-systolic volumes. | Assessed by echo. | baseline and 6 months | |
Secondary | Change in clinical parameters | Quality of life measured by New York Heart Association (NYHA) classification. | baseline and 6 months | |
Secondary | Change in clinical parameters | Quality of life measured by Kansas City Cardiomyopathy Questionnaire (KCCQ). | baseline and 6 months | |
Secondary | Improvement in clinical parameters | Quality of life measured by European Heart Rhythm Association score of atrial fibrillation (EHRA AF). | baseline and 6 months | |
Secondary | Change in 6-Minute walk test. | Standard measurement. | baseline and 6 months | |
Secondary | Laboratory parameters. | NT-proB-type Natriuretic Peptide (BNP) | baseline and 6 months | |
Secondary | Procedural-related characteristics. | Total procedure and fluoroscopy time. | peri-procedural | |
Secondary | Procedure-associated adverse events. | Lead dislocations, device infection, bleeding, pneumotorax, etc. | peri-procedural, 30 days after the procedure | |
Secondary | Need for procedural reintervention. | Unplanned reintervention due to lead dysfunction or dislocation, device infection etc. | at least 24 months | |
Secondary | ECG parameters. | QRS duration and morphology. | before and after the procedure | |
Secondary | Pacing parameters. | Capture threshold measurement. | peri-procedural, at least 24 months | |
Secondary | Number of detected sustained VT/VF. | Detected sustained ventricular tachycardia or ventricular fibrillation on pacemaker telemetry. | at least 24 months |
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