Insulin Resistance as a Predictor of Pulsed Field Ablation Success in Atrial Fibrillation (HOMA-PULSE)

NCT07551947 | Enrolling By Invitation

• 3 other identifiers: HOMA-PULSE-2026EK KLH_EK_01_HOMA PULSEINT2025003
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation; Insulin Resistance; Catheter Ablation; Artificial Intelligence

Keywords

atrial fibrillation; pulsed field ablation; insulin resistance; HOMA-IR; GDF-15; reablation; metabolic predictors; non-diabetic; biomarkers; electroporation; pulmonary vein isolation; neural network; intracardiac electrograms; deep learning; artificial intelligence; signal analysis

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline HOMA-IR measurement to reablation decision at 4-5 months post-ablation

Secondary Outcomes (4)

• Optimal HOMA-IR Cut-Off Value for Predicting Reablation

  Baseline HOMA-IR to reablation decision at 4-5 months

• Association Between GDF-15 and Ablation Outcomes

  Baseline GDF-15 to reablation decision at 4-5 months

• Area Under ROC Curve (AUC) of Multiparametric Predictive Model for Reablation Indication

  Baseline parameters to reablation decision at 4-5 months

• Area Under ROC Curve (AUC) of Neural Network Intracardiac Electrogram Model for Predicting Reablation

  Intracardiac signals recorded during ablation procedure (baseline) to reablation decision at 4-5 months

Other Outcomes (3)

• Correlation Coefficient Between Baseline HOMA-IR and Total Pulsed Field Ablation Procedure Time

  Baseline HOMA-IR and procedural parameters on day of ablation

• Correlation Coefficient Between Baseline HOMA-IR and Left Atrial Volume Index

  Baseline (day of ablation)

• Number of Participants with Reablation Indication Stratified by Baseline HOMA-IR Tertile and Pharmacotherapy Class

  Baseline HOMA-IR and medication status to reablation decision at 4-5 months

Study Arms (2)

Normal Insulin Sensitivity

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.

Insulin Resistant

Patients with HOMA-IR \> 2.5, classified as insulin resistant. Undergo standard PFA ablation for atrial fibrillation with follow-up at 4-5 months.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• Age \>= 18 years
• Undergoing first catheter ablation for atrial fibrillation using pulsed field ablation (PFA)
• No known diagnosis of diabetes mellitus
• Signed written informed consent

You may not qualify if:

• Known diabetes mellitus or active antidiabetic treatment
• Previous atrial fibrillation ablation by any method
• Pregnancy
• Severe renal insufficiency (eGFR \< 30 mL/min)
• Other severe comorbidities limiting follow-up
• Inability to provide informed consent

Sponsors & Collaborators

• Nemocnice AGEL Trinec-Podlesi a.s.: lead

Study Sites (1)

Kardiocentrum, Nemocnice AGEL Trinec-Podlesi a.s.

Třinec, 73961, Czechia

Location

Related Publications (3)

• Donnellan E, Aagaard P, Kanj M, et al. Association Between Pre-Ablation Glycemic Control and Outcomes Among Patients With Diabetes Undergoing Atrial Fibrillation Ablation. JACC Clin Electrophysiol. 2019;5(8):897-903.

  BACKGROUND

• Chan YH, Chang GJ, Lai YJ, et al. Atrial fibrillation and its arrhythmogenesis associated with insulin resistance. Cardiovasc Diabetol. 2019;18(1):125.

  BACKGROUND

• Reddy VY, Dukkipati SR, Neuzil P, et al. Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PULSED AF. JACC Clin Electrophysiol. 2022;8(3):315-331.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fasting venous blood samples (serum and plasma aliquots) stored at -80 degrees Celsius for insulin, GDF-15, IL-6, IL-1beta, and other biomarker analysis.

MeSH Terms

Conditions

Atrial Fibrillation; Insulin Resistance

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Otakar Jiravsky, MUDr., Ph.D., MBA

  Nemocnice AGEL Trinec-Podlesi a.s.

  PRINCIPAL INVESTIGATOR

• Jan Chovancik, MUDr., Ph.D.

  Nemocnice AGEL Trinec-Podlesi a.s.

  SUB INVESTIGATOR

• Jan Adamek, MUDr.

  Nemocnice AGEL Trinec-Podlesi a.s.

  SUB INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Arrhythmology, Cardiocentrum

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

CZ (1)