An observational study in Atrial Fibrillation, Insulin Resistance and Catheter Ablation, sponsored by Nemocnice AGEL Trinec-Podlesi a.s.. Enrolling by invitation at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by Nemocnice AGEL Trinec-Podlesi a.s. · Observational
This study investigates whether insulin resistance, a metabolic condition where the body's cells respond poorly to insulin, can predict the success of atrial fibrillation (AF) ablation using pulsed field ablation (PFA) technology.
Atrial fibrillation is the most common heart rhythm disorder, affecting 2-4% of adults. Catheter ablation is an effective treatment, but 20-40% of patients require a repeat procedure. Identifying patients at higher risk of ablation failure could improve treatment planning and outcomes.
Scientific evidence suggests that insulin resistance - which can exist for years before diabetes develops - may contribute to electrical and structural changes in the heart that promote AF. However, no prospective study has systematically examined whether insulin resistance measured by the HOMA-IR index predicts ablation outcomes, particularly with the newest pulsed field ablation technology.
HOMA-PULSE is a prospective observational study enrolling at least 120 non-diabetic patients undergoing their first AF ablation using pulsed field ablation at the Cardiocentrum, AGEL Hospital Trinec-Podlesi, Czech Republic.
On the day of ablation, fasting blood samples are collected as part of routine preoperative care. A portion of these samples is used to measure insulin resistance (HOMA-IR index, calculated from fasting glucose and insulin levels) along with additional biomarkers including GDF-15, hs-CRP, NT-proBNP, IL-6, and IL-1beta. Detailed procedural and clinical data are recorded.
Patients attend a single follow-up visit at 4-5 months post-ablation - a standard part of clinical care after AF ablation. The primary outcome is the clinical decision regarding need for repeat ablation (reablation), made by the treating physician blinded to the HOMA-IR result.
The study does not involve any additional procedures, visits, or interventions beyond standard clinical care. The only research-specific element is the additional laboratory analysis of biomarkers from blood samples that would be drawn regardless of study participation.
Additionally, intracardiac electrograms recorded during the ablation procedure will be analyzed using deep learning neural network models to extract electrophysiological features and evaluate whether insulin resistance has a detectable electrophysiological signature that can be captured by artificial intelligence.
If a significant association between insulin resistance and ablation outcomes is confirmed, this could lead to new strategies combining ablation with metabolic optimization to improve success rates.
BACKGROUND:
Atrial fibrillation (AF) is the most common cardiac arrhythmia, with a prevalence of 2-4% in the adult population that is increasing exponentially. Catheter ablation is an established treatment for symptomatic AF, but primary ablation success rates range from 60-80%, with a significant proportion of patients requiring reablation. Identification of clinically relevant predictors of ablation success remains a key research challenge.
Diabetes mellitus increases AF risk 1.5-2-fold and is associated with faster progression from paroxysmal to persistent AF. Experimental data suggest that insulin resistance (IR) preceding manifest diabetes may contribute to electrical and structural atrial remodeling through oxidative stress, microvascular dysfunction, and local fibrosis. Despite robust experimental evidence, no prospectively designed study has systematically evaluated the association between HOMA-IR and AF ablation outcomes, particularly in non-diabetic patients where early detection of metabolic abnormalities could have the greatest clinical benefit.
Pulsed field ablation (PFA) represents the newest generation of catheter ablation technology, using irreversible electroporation to achieve selective myocardial ablation with minimal collateral damage. While studies have evaluated the impact of diabetes on radiofrequency ablation outcomes, data on the predictive value of subclinical glucose metabolism disorders in patients undergoing PFA are virtually absent.
The HOMA-IR index (Homeostatic Model Assessment of Insulin Resistance) is a validated, clinically available tool for quantifying insulin resistance, calculated from fasting glucose and insulin levels.
GDF-15 (Growth Differentiation Factor 15) has been identified as a potential link between metabolic and cardiovascular phenotypes, associated with both insulin resistance and AF recurrence risk. Its measurement alongside HOMA-IR may provide deeper insight into pathophysiological mechanisms connecting metabolic abnormalities with atrial electrical instability.
STUDY DESIGN:
Single-arm prospective observational monocentric study at the Cardiocentrum, AGEL Hospital Trinec-Podlesi, Czech Republic, 2026-2028.
ASSESSMENT SCHEDULE:
BLINDING:
The treating physician making the reablation decision is blinded to the HOMA-IR value and other study-specific biomarker results.
STATISTICAL ANALYSIS:
Sample size: >=120 patients, providing adequate statistical power (beta=0.8, alpha=0.05) to detect a 2-fold relative risk of reablation in patients with elevated HOMA-IR, assuming 10-15% reablation frequency and 40% prevalence of abnormal insulin resistance in non-diabetic cardiovascular patients. Patients stratified by HOMA-IR tertiles. Continuous variables expressed as mean +/- SD or median (IQR) and compared using t-test or Mann-Whitney U test. Categorical variables compared using chi-square or Fisher's exact test. Multivariable logistic regression with adjustment for relevant clinical covariates used to identify independent predictors of reablation. ROC analysis to determine optimal HOMA-IR cut-off value. Final scoring system integrating HOMA-IR with other significant predictors. Deep learning neural network models (CNN/RNN) will be applied to intracardiac electrogram data recorded during ablation to extract electrophysiological features and evaluate their correlation with metabolic status and ablation outcomes. Analysis performed using SPSS v.30 and Python (TensorFlow/PyTorch).
DATA MANAGEMENT:
All data anonymized and processed in compliance with GDPR. Electronic data stored in password-protected secure database. Patient identification codes maintained separately from research data. Access restricted to authorized research team members only.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 120 is below the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Nemocnice AGEL Trinec-Podlesi a.s. is the lead sponsor of 9 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Non-diabetic adults with atrial fibrillation (paroxysmal or persistent) indicated for first catheter ablation using pulsed field ablation at a single tertiary cardiology center (Cardiocentrum, AGEL Hospital Trinec-Podlesi, Czech Republic).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with HOMA-IR \<= 2.5, classified as having normal insulin sensitivity. Undergo standard PFA ablation for atrial fibrillation with follow-up at 4-5 months.
Patients with HOMA-IR \> 2.5, classified as insulin resistant. Undergo standard PFA ablation for atrial fibrillation with follow-up at 4-5 months.
Rate of Reablation at 4-5 Months
Clinical decision regarding the need for repeat ablation (reablation) based on clinical status and findings during the follow-up examination at 4-5 months after primary PFA ablation. Binary outcome (yes/no). Decision made by the treating physician blinded to HOMA-IR values, based on: recurrence of symptomatic atrial fibrillation, symptomatic atrial tachycardias, or asymptomatic AF recurrence documented on ECG/Holter monitoring. Assessment includes: clinical symptom evaluation (EHRA score), 12-lead ECG, and minimum 24-hour Holter ECG monitoring.
Time frame: 4 to 5 months after primary PFA ablation
Prevalence of Insulin Resistance in Non-Diabetic AF Patients Undergoing PFA
Proportion of enrolled non-diabetic patients with abnormal insulin sensitivity defined as HOMA-IR \> 2.5, calculated from fasting glucose and insulin levels measured on the day of ablation.
Time frame: Baseline (day of ablation)
Association Between HOMA-IR and Reablation Risk
Odds ratio (OR) for the association between HOMA-IR and the indication for reablation, adjusted for relevant clinical covariates (age, sex, BMI, AF type, left atrial size, LVEF, CHA2DS2-VA score, comorbidities, and pharmacotherapy) using multivariable logistic regression analysis.
Time frame: Baseline HOMA-IR measurement to reablation decision at 4-5 months post-ablation
Optimal HOMA-IR Cut-Off Value for Predicting Reablation
4a. Area Under ROC Curve (AUC) of HOMA-IR for Predicting Reablation Indication Description: Discriminatory performance of baseline HOMA-IR as a predictor of reablation indication, quantified as the area under the receiver operating characteristic (ROC) curve with 95% confidence interval. An AUC of 0.5 indicates no discrimination; 1.0 indicates perfect discrimination. Time Frame: Baseline HOMA-IR to reablation decision at 4-5 months Unit of Measure: AUC (dimensionless, range 0.0-1.0) 4b. Optimal HOMA-IR Cut-Off Value for Predicting Reablation Indication Description: Optimal threshold value of baseline HOMA-IR identified from the ROC curve using the Youden index (maximizing sensitivity + specificity - 1). Reported with 95% confidence interval obtained by bootstrapping. Time Frame: Baseline HOMA-IR to reablation decision at 4-5 months Unit of Measure: HOMA-IR v
Time frame: Baseline HOMA-IR to reablation decision at 4-5 months
Association Between GDF-15 and Ablation Outcomes
Association between baseline Growth Differentiation Factor 15 (GDF-15) levels and the indication for reablation, including correlation with HOMA-IR (Pearson or Spearman coefficient). Assessment of additive prognostic value of combining GDF-15 with HOMA-IR compared to HOMA-IR alone (comparison of AUC values).
Time frame: Baseline GDF-15 to reablation decision at 4-5 months
Area Under ROC Curve (AUC) of Multiparametric Predictive Model for Reablation Indication
Description: Discriminatory performance of a multiparametric predictive model integrating baseline HOMA-IR with clinical and biochemical parameters (lipid profile, high-sensitivity C-reactive protein, GDF-15, NT-proBNP, left atrial volume index, age, sex, and body mass index) for predicting reablation indication. The model is developed by multivariable logistic regression with internal validation by bootstrapping (1000 resamples). Discriminatory performance is quantified as the area under the receiver operating characteristic (ROC) curve, reported with 95% confidence interval. An AUC of 0.5 indicates no discrimination; 1.0 indicates perfect discrimination. Calibration (Hosmer-Lemeshow test, calibration slope) and reclassification (NRI, IDI) will be reported in the accompanying publication as secondary analyses.
Time frame: Baseline parameters to reablation decision at 4-5 months
Area Under ROC Curve (AUC) of Neural Network Intracardiac Electrogram Model for Predicting Reablation
Discriminatory performance of a deep learning neural network model (convolutional neural network) trained to extract electrophysiological features from intracardiac electrograms recorded during pulsed field ablation. Features include local atrial activation patterns, signal amplitude, fractionation indices, and conduction velocity. The model output is evaluated as a predictor of reablation indication. Performance is quantified as the area under the receiver operating characteristic curve with 95% confidence interval from internal cross-validation. Correlation of the neural network feature score with baseline HOMA-IR (Spearman coefficient) and improvement over HOMA-IR alone (integrated discrimination improvement) will be reported as secondary analyses in the publication.
Time frame: Intracardiac signals recorded during ablation procedure (baseline) to reablation decision at 4-5 months
Correlation Coefficient Between Baseline HOMA-IR and Total Pulsed Field Ablation Procedure Time
Spearman rank correlation coefficient between baseline HOMA-IR (calculated from fasting plasma glucose and insulin on the day of ablation) and total pulsed field ablation procedure time (defined as the interval from vascular access to sheath removal, measured by the electrophysiology recording system). The analysis tests whether higher insulin resistance is associated with longer procedure duration, potentially reflecting more complex atrial substrate. Reported with 95% confidence interval. Additional procedural parameters (fluoroscopy time, number of PFA applications, acute pulmonary vein isolation success, need for additional ablation lines) will be reported in the accompanying publication as supplementary correlations.
Time frame: Baseline HOMA-IR and procedural parameters on day of ablation
Correlation Coefficient Between Baseline HOMA-IR and Left Atrial Volume Index
Spearman rank correlation coefficient between baseline HOMA-IR and left atrial volume index, measured by transthoracic echocardiography using the biplane area-length or Simpson method in apical 4- and 2-chamber views at end-systole and indexed to body surface area. The analysis tests whether higher insulin resistance is associated with greater left atrial remodeling, a key substrate for atrial fibrillation recurrence. Reported with 95% confidence interval. Additional echocardiographic parameters (left atrial area, left ventricular ejection fraction, left atrial strain) will be reported in the accompanying publication as supplementary correlations.
Time frame: Baseline (day of ablation)
Number of Participants with Reablation Indication Stratified by Baseline HOMA-IR Tertile and Pharmacotherapy Class
Count of participants with reablation indication at 4-5 months, stratified jointly by baseline HOMA-IR tertile (low, middle, high) and baseline pharmacotherapy class at the time of index ablation (beta-blockers, ACE inhibitors or angiotensin receptor blockers, statins, SGLT2 inhibitors or GLP-1 receptor agonists). The primary analysis evaluates whether pharmacotherapy modifies the association between HOMA-IR and reablation risk. Interaction between HOMA-IR (continuous) and each pharmacotherapy class will be formally tested in logistic regression models with interaction terms, with results reported in the accompanying publication.
Time frame: Baseline HOMA-IR and medication status to reablation decision at 4-5 months
Plan to share: Undecided — Anonymized dataset of metabolic, demographic, and electrophysiological parameters may be made available after study completion and primary publication, upon reasonable request to the Principal Investigator.
Started Apr 2026 (actual). Primary completion is estimated for Dec 2028, 32 months after the start.
Of 550 non-industry observational studies under Atrial Fibrillation, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 91. This study's planned 32 months is below that.
Counting every sponsor, half of 698 studies reached it within 38 months; a quarter within 22 and three quarters within 76.
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Nemocnice AGEL Trinec-Podlesi a.s.