Atrial FibrillationHOMA-PULSENCT07551947
Insulin Resistance as a Predictor of Pulsed Field Ablation Success in Atrial Fibrillation (HOMA-PULSE)
An observational study of Atrial Fibrillation and Insulin Resistance, run by Nemocnice AGEL Trinec-Podlesi a.s. at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Insulin Resistance, Catheter Ablation
- How many people
- 120 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Apr 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: HOMA-PULSE: Assessment of Glucose Metabolism and Insulin Resistance as a Predictor of Pulsed Field Ablation Success in Atrial Fibrillation
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.
Read more
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.
Read the detailed description
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:
- Baseline (day of ablation): Fasting blood samples collected during routine preoperative preparation for HOMA-IR calculation (fasting glucose + insulinemia), complete lipid profile, inflammatory markers (hs-CRP, fibrinogen, leukocytes, IL-6, IL-1beta), cardiovascular biomarkers (NT-proBNP), and specific biomarkers (GDF-15). Demographic, clinical, echocardiographic, and ECG parameters recorded. Standardized PFA ablation performed with detailed procedural documentation including recording of intracardiac electrograms (EGMs) for subsequent neural network analysis.
- Follow-up (4-5 months post-ablation): Single standard clinical visit including symptom assessment (EHRA score), 12-lead ECG, Holter monitoring (minimum 24 hours), and clinical decision regarding reablation indication.
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.
- 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
- Medical subject headings
- Atrial Fibrillation, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Intracardiac signals recorded during ablation procedure (baseline) to reablation decision at 4-5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start1 Apr 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemocnice AGEL Trinec-Podlesi a.s.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Otakar Jiravsky, Nemocnice AGEL Trinec-Podlesi a.s.
- Investigators
- Otakar Jiravsky, MUDr., Ph.D., MBA, Principal investigator, Nemocnice AGEL Trinec-Podlesi a.s.Jan Chovancik, MUDr., Ph.D., Sub-investigator, Nemocnice AGEL Trinec-Podlesi a.s.Jan Adamek, MUDr., Sub-investigator, Nemocnice AGEL Trinec-Podlesi a.s.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551947
- Sponsor's protocol ID
- HOMA-PULSE-2026
- Other IDs
- EK KLH_EK_01_HOMA PULSE, INT2025003
- Acronym
- HOMA-PULSE
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Donnellan E, Aagaard P, Kanj M, Jaber W, Elshazly M, Hoosien M, Baranowski B, Hussein A, Saliba W, Wazni O. Association Between Pre-Ablation Glycemic Control and Outcomes Among Patients With Diabetes Undergoing Atrial Fibrillation Ablation. JACC Clin Electrophysiol. 2019 Aug;5(8):897-903. doi: 10.1016/j.jacep.2019.05.018. Epub 2019 Jul 31.
PubMed 31439289Chan YH, Chang GJ, Lai YJ, Chen WJ, Chang SH, Hung LM, Kuo CT, Yeh YH. Atrial fibrillation and its arrhythmogenesis associated with insulin resistance. Cardiovasc Diabetol. 2019 Sep 26;18(1):125. doi: 10.1186/s12933-019-0928-8.
PubMed 31558158Reddy VY, Dukkipati SR, Neuzil P, Anic A, Petru J, Funasako M, Cochet H, Minami K, Breskovic T, Sikiric I, Sediva L, Chovanec M, Koruth J, Jais P. Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II. JACC Clin Electrophysiol. 2021 May;7(5):614-627. doi: 10.1016/j.jacep.2021.02.014. Epub 2021 Apr 28.
PubMed 33933412
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOMA-PULSE: Assessment of Glucose Metabolism and Insulin Resistance as a Predictor of Pulsed Field Ablation Success in Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07551947
- Acronym / sponsor ID
- HOMA-PULSE / HOMA-PULSE-2026
- Keywords
- atrial fibrillation, pulsed field ablation, insulin resistance, HOMA-IR, GDF-15, reablation, metabolic predictors, non-diabetic
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nemocnice AGEL Trinec-Podlesi a.s.University, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Baseline (day of ablation): Fasting blood samples collected during routine preoperative preparation for HOMA-IR calculation (fasting glucose + insulinemia), complete lipid profile, inflammatory markers (hs-CRP, fibrinogen, leukocytes, IL-6, IL-1beta), cardiovascular biomarkers (NT-proBNP), and specific biomarkers (GDF-15). Demographic, clinical, echocardiographic, and ECG parameters recorded. Standardized PFA ablation performed with detailed procedural documentation including recording of intracardiac electrograms (EGMs) for subsequent neural network analysis.
- Follow-up (4-5 months post-ablation): Single standard clinical visit including symptom assessment (EHRA score), 12-lead ECG, Holter monitoring (minimum 24 hours), and clinical decision regarding reablation indication.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of Reablation at 4-5 Months
Time frame: 4 to 5 months after primary PFA ablation
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.
Prevalence of Insulin Resistance in Non-Diabetic AF Patients Undergoing PFA
Time frame: Baseline (day of ablation)
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.
Association Between HOMA-IR and Reablation Risk
Time frame: Baseline HOMA-IR measurement to reablation decision at 4-5 months post-ablation
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.
4 secondary outcomes
Optimal HOMA-IR Cut-Off Value for Predicting Reablation
Time frame: Baseline HOMA-IR to reablation decision at 4-5 months
Association Between GDF-15 and Ablation Outcomes
Time frame: Baseline GDF-15 to reablation decision at 4-5 months
Area Under ROC Curve (AUC) of Multiparametric Predictive Model for Reablation Indication
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
Time frame: Intracardiac signals recorded during ablation procedure (baseline) to reablation decision at 4-5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Background: PubMed 31439289Donnellan E, Aagaard P, Kanj M, Jaber W, Elshazly M, Hoosien M, Baranowski B, Hussein A, Saliba W, Wazni O. Association Between Pre-Ablation Glycemic Control and Outcomes Among Patients With Diabetes Undergoing Atrial Fibrillation Ablation. JACC Clin Electrophysiol. 2019 Aug;5(8):897-903. doi: 10.1016/j.jacep.2019.05.018. Epub 2019 Jul 31.
- Background: PubMed 31558158Chan YH, Chang GJ, Lai YJ, Chen WJ, Chang SH, Hung LM, Kuo CT, Yeh YH. Atrial fibrillation and its arrhythmogenesis associated with insulin resistance. Cardiovasc Diabetol. 2019 Sep 26;18(1):125. doi: 10.1186/s12933-019-0928-8.
- Background: PubMed 33933412Reddy VY, Dukkipati SR, Neuzil P, Anic A, Petru J, Funasako M, Cochet H, Minami K, Breskovic T, Sikiric I, Sediva L, Chovanec M, Koruth J, Jais P. Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II. JACC Clin Electrophysiol. 2021 May;7(5):614-627. doi: 10.1016/j.jacep.2021.02.014. Epub 2021 Apr 28.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Otakar Jiravsky, MUDr., Ph.D., MBA principal investigator
Nemocnice AGEL Trinec-Podlesi a.s.
Jan Chovancik, MUDr., Ph.D. sub-investigator
Nemocnice AGEL Trinec-Podlesi a.s.
Jan Adamek, MUDr. sub-investigator
Nemocnice AGEL Trinec-Podlesi a.s.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Insulin Resistance, run by Nemocnice AGEL Trinec-Podlesi a.s. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Reablation at 4-5 Months (time frame: 4 to 5 months after primary PFA ablation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07551947, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.