Electrogram-guided ablation
Procedurepulmonary vein ioslation; target electrograms ablation, including (1) Spatial-temporal Dispersion Activation, (2) Locally Short Cycle Length Activity, (3) High-Frequency Potentials, (4) Focal Activity.
NCT Number: NCT07153718
Atrial fibrillation (AF) in the context of heart failure (HF) is associated with a markedly poor prognosis. Catheter ablation has been shown to improve outcomes in this population, enhancing ablation success rates in these patients is critical for further reducing morbidity and mortality. We conducted this multicenter, randomized clinical trial to systematically evaluate the optimal ablation strategy in patients with heart failure and persistent AF.
This study is active but is not currently recruiting participants.
18 year–80 year
All sexes
Interventional
Not applicable
The PLA Navy Anqing Hospital, Anqing, Anhui, China
Atrial fibrillation (AF) in the context of heart failure (HF) is associated with a markedly poor prognosis, with one-year all-cause mortality rates approaching 34% and substantially elevated risks of stroke and rehospitalization. Catheter ablation has been shown to improve outcomes in this population, as evidenced by numerous pivotal studies, such as CASTLE-AF. It is well recognized that the majority of patients with HF and AF exhibit persistent AF; however, the underlying mechanisms responsible for sustaining persistent AF in this population remain to be fully elucidated. Thus, enhancing ablation success rates in these patients is therefore critical for further reducing morbidity and mortality.
Building on prior research, we have identified driver regions as critical determinants in the maintenance of persistent atrial fibrillation. Moreover, our randomized controlled trials have demonstrated that electro-anatomical ablation may represent the optimal strategy for persistent AF. Based on these findings, we conducted a multicenter, randomized clinical trial to systematically evaluate the optimal ablation strategy in patients with heart failure and persistent AF.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Heart Failure with Reduced Ejection Fraction (HFrEF): LVEF ≤ 40%. Heart Failure with Preserved Ejection Fraction (HFpEF): LVEF > 40%, including HFmrEF (LVEF 41-50%).
Exclusion criteria
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pulmonary vein ioslation; target electrograms ablation, including (1) Spatial-temporal Dispersion Activation, (2) Locally Short Cycle Length Activity, (3) High-Frequency Potentials, (4) Focal Activity.
pulmonary vein isolation; LA roof, posterior inferior wall and mitral isthmus linear lesion; Vein of Marshall (VOM) ethanol infusion.
pulmonary vein isolation; target electrogram ablation; linear ablation
Time frame: 12, 18, 24, 36, 46, 60months
The primary endpoint was the incidence of a composite of cardiovascular mortality, hospitalization or urgent visits due to worsening heart failure during the follow-up period after a single catheter ablation procedure
Time frame: 12, 18, 24, 36, 48, 60months
freedom from any documented AF/AT episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drug treatment
Time frame: 12, 24, 36, 48, 60 months after a single procedure
AF burden <1% after a single ablation procedure, as measured by Holter monitoring or device-recorded data (Patients who remained in persistent AF throughout follow-up were assigned AF burden=100%. Both ends of the distribution (burden=0% and burden=100%) were included in statistical analysis.).
Time frame: 12, 24, 36, 48, 60 months after a single procedure
Improvement in New York Heart Association (NYHA) functional class by at least one grade
Time frame: 12, 24, 36, 48, 60 months after a single procedure
Change in 6-minute walk test from baseline to Month 3, 12, 24, 36, 48, 60 months after a single procedure
Time frame: Month 3,12, 24, 36, 48, 60 after a single procedure
Change in N-terminal pro-B type natriuretic peptide (NT-proBNP) from baseline to Month 3,12, 24, 36, 48, 60 after a single procedure
Time frame: 30 days after a single procedure
Incidence of procedure-related complications, including but not limited to: vascular complications (e.g., hematoma, pseudoaneurysm), cardiac tamponade, stroke or transient ischemic attack (TIA), phrenic nerve injury, atrioesophageal fistula, procedure-related death within 30 days.
Xu Liu
Other
Optimal Ablation Strategies for Persistent Atrial Fibrillation With Heart Failure - Optimization of Intervention Strategies for Persistent Atrial Fibrillation
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