Atrial FibrillationUNCOVER-PVINCT05677516
Incidence and Duration of Unintentional Neuromodulation Effects After Pulmonary Vein Isolation in Patients With Atrial Fibrillation.
An observational study of Atrial Fibrillation, run by 4th Military Clinical Hospital with Polyclinic, Poland at 2 sites in Poland.
Trial summary
Pulmonary vein isolation (PVI) is a proven, high-efficiency treatment for atrial fibrillation (AF). Performed, among others, using cryoablation, pulsed field ablation (PFA) or radiofrequency (RF) ablation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- ablation- pulmonary vain isolation- crioablation, ablation- pulmonary vain isolation- pulsed field ablation (PFA) and ablation- pulmonary vain isolation- radiofrequency ablation (RF)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 2 sitesPoland
- Study dates
- 23 Dec 2021to 23 Dec 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study group will consist of patients aged 18-85. With paroxysmal or persistent atrial fibrillation. Qualified for PVI according to the guidelines of the European Society of Cardiology.
Who may be able to join
- Patients qualified for PVI due to paroxysmal or persistent atrial fibrillation.
- Signed and dated written informed consent prior to admission to the trial.
Who cannot join
- Any underwent cardiac ablation.
- A history of cardiac surgery.
- Pregnancy.
- Diseases affecting the autonomic nervous system.
- Change in heart rhythm during PVI, with no conversion to the primary rhythm at the end of the procedure.
- Cardiac pacing during Holter ECG monitoring.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites, 2 recruiting
- Recruiting
Polish-American Heart Clinics Cardiovascular Center in Dąbrowa Górnicza, American Heart of Poland Group
Dąbrowa Górnicza, Silesian Voivodeship, 41-300
Sebastian Stec, PhD, +48600298022, smstec@wp.pl
Sebastian Stec, PhD
- Recruiting
4th Military Hospital, Cardiology Department
Wroclaw, Lower Silesian Voivodeship, 50-981
Przemysław Skoczyński, PhD, +48602753043, przeskocz@tlen.pl
Bruno Hrymniak, MD, +48603766801, bruno.hrymniak@gmail.com
About this study
Official title: Incidence and Duration of Unintentional Neuromodulation Effects After Pulmonary Vein Isolation in Patients With Atrial Fibrillation. (UNCOVER-PVI)
Pulmonary vein isolation (PVI) is a proven, high-efficiency treatment for atrial fibrillation (AF). Performed, among others, using cryoablation, pulsed field ablation (PFA) or radiofrequency (RF) ablation. It has been shown that its effectiveness significantly increases when the PVI procedure is combined with cardioneuroablation (CNA). The autonomic nervous system - ganglionated plexi (GP), the target of the CNA, are the endings of the vagal nerve and are located in the neighborhood of the pulmonary veins ostia. Places that, in many cases, are unintentionally damaged during PVI. Varying degrees of injury to the GP during PVI indicate that the group of patients undergoing PVI is heterogeneous in this regard, and the effectiveness of PVI may vary. Vagal nerve endings damage during CNA abolishes or modifies its activity, which is manifested by the acceleration of sinus rhythm and increased atrioventricular conduction efficiency. Unintended CNA is not observed in every PVI procedure. The severity of the unintended CNA effect and its duration also vary.
THE STUDY OBJECTIVES:
- Frequency of unintentional CNA occurrence during PVI
- Duration effect of CNA after unintentional CNA
- Evaluation of the relationship between the different kinds of energy - cryo, pulsed field) and RFwith the unintentional CNA frequency occurrence and durability effect
- Clinical significance evaluation of the new assessment method of the CNA effectiveness with the measure of the cSNRT and the sinus rate after its return, measured before and after PVI
- Assessment of clinical significance for CNA evaluation of the electrophysiological parameters of AV node conduction efficiency, such as PQ interval, AH interval, HV interval, and Wenckebach's point. Parameters will be examined before and after PVI.
- PVI efficacy evaluation with the AF and Sick Sinus Syndrome treatment, especially with the elimination of the indications for the PM implantation (sinus bradycardia, AV conduction disorders)
- Assessment of sinus rhythm maintenance after PVI with unintentional CNA and without unintentional CNA
- Assessment of ventricular rate control during AF burden after unintentional CNA
- The search for new parameters evaluating the effectiveness and degree of CNA, such as the change in SR frequency after its return, may prove helpful and allow for resignation or significantly reduce the use of the complicated protocol of extracardiac vagal ganglion stimulation (ECVS) as a method to verify the effectiveness CNAs.
Read the detailed description
This is a multi-centre, prospective, observational study, which will include patients with paroxysmal or persistent atrial fibrillation qualified for PVI by the European Society of Cardiology guidelines. Pulmonary veins will be isolated with three kinds of energies: cryo, pulsed field and RF. The study group will consist of four subgroups:
- Patients undergoing cryoablation of pulmonary veins with paroxysmal or persistent AF with ongoing AF during ablation
- Patients undergoing cryoablation of pulmonary veins with paroxysmal AF, in sinus rhythm during the procedure
- Patients undergoing pulmonary veins isolation with PFA with paroxysmal AF, in sinus rhythm during the procedure
- Patients undergoing RF ablation of the pulmonary veins using an electroanatomical system with paroxysmal AF, in sinus rhythm during the procedure
The effect of unintentional neuromodulation will be assessed based on the following:
- ECG Holter monitoring performed before and after the procedure in all groups
- Parameters assessed in EPS before and after the procedure in groups 2,3, and 4.
The long-term effect of neuromodulation and its impact on maintaining sinus rhythm will be assessed based on the following:
- The Holter ECG monitoring in groups 2,3, and 4.
- The interview in all groups after three months of observation.
PROTOCOL STUDY:
GROUP 1:
- Holter ECG prior to PVI
- Holter ECG after PVI
- Survey after three months of observation.
GROUPS 2,3 AND 4:
- Holter ECG prior to PVI
- EPS prior to PVI
- EPS after PVI
- Holter ECG prior to PVI
- Holter ECG after three to six months of observation
- Survey after three months of observation.
All the measured parameters as well as demographic and clinical data will be recorded in the study database.
- Conditions
- Atrial Fibrillation
- Being tested
- ablation- pulmonary vain isolation- crioablation, ablation- pulmonary vain isolation- pulsed field ablation (PFA), ablation- pulmonary vain isolation- radiofrequency ablation (RF), Electrophysiological study (EPS), Holter EKG
- Keywords
- pulmonary vains isolation, catdioneuroablation, cardioneuromodultion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ablation- pulmonary vain isolation- crioablationProcedure or surgery
Pulmonary vein isolation is the electrical isolation of the pulmonary veins from the left atrium. It can be performed using the cryoablation technique. The procedure begins with venous access through the femoral vein through which catheters and electrodes are inserted. Then, the left atrium is accessed through a transseptal puncture and the pulmonary veins are isolated using a cryoablation balloon. Cryoablation procedures are performed under local anesthesia. The procedure is performed using X-ray fluoroscopy.
ablation- pulmonary vain isolation- pulsed field ablation (PFA)Procedure or surgery
Pulmonary vein isolation is the electrical isolation of the pulmonary veins from the left atrium. It can be performed using the pulsed field ablation (PFA) technique. The procedure begins with venous access through the femoral vein through which catheters and electrodes are inserted. Then, the left atrium is accessed through a transseptal puncture and the pulmonary veins are isolated with a PFA electrode. PFA procedures are performed under general anesthesia. The procedure is performed using X-ray fluoroscopy.
ablation- pulmonary vain isolation- radiofrequency ablation (RF)Procedure or surgery
Pulmonary vein isolation is the electrical isolation of the pulmonary veins from the left atrium. It can be performed using the radiofrequency ablation (RF) technique. The procedure begins with venous access through the femoral vein through which catheters and electrodes are inserted. Then, the left atrium is accessed through a transseptal puncture and the pulmonary veins are isolated with a RF electrode. RF procedures are performed under local anesthesia. The procedure is performed using X-ray fluoroscopy.
Electrophysiological study (EPS)Procedure or surgery
In the electrophysiological study (EPS), electrophysiological parameters such as the recovery time of sinus rhythm (SNRT), Wenckebach's point, AH and HV intervals are measured. The examination begins with venous access through the femoral vein. Then, diagnostic electrodes are inserted into the right atrium, right ventricle and coronary sinus, with which electrophysiological tests are performed. The SNRT is measured after 60 seconds of atrial pacing with a 600ms cycle. The Wencjabach point is determined by stimulation in the incremental protocol. AV and HV intervals are measured during sinus rhythm using an electrode placed on the bundle of His. EPS is performed under local anesthesia. EPS will be performed both before and after pulmonary vein isolation. In patients with atrial fibrillation, during ablation, only the HV interval will be measured.
The procedure is performed using X-ray fluoroscopy.
Holter EKGDiagnostic test
Holter ECG is a 24-hour, non-invasive ECG recording using a portable recorder and electrodes placed on the patient's chest. The Holter ECG will be performed three times: on the day preceding and on the first day after pulmonary veins isolation, and after 3 months of observation.
QuestionnaireOther
The survey will be conducted after 3 months of observation and will include questions about the number of hospitalizations due to atrial fibrillation, heart palpitations, changes in pharmacotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients undergoing cryoablation of pulmonary veins with paroxysmal or persistent AF with ongoing AF during ablation. Receives: Procedure: ablation- pulmonary vain isolation- crioablation; Procedure: Electrophysiological study (EPS); Diagnostic Test: Holter EKG; Other: Questionnaire | |
| Group 2 | Patients undergoing cryoablation of pulmonary veins with paroxysmal AF, in sinus rhythm during the procedure. Receives: Procedure: ablation- pulmonary vain isolation- crioablation; Procedure: Electrophysiological study (EPS); Diagnostic Test: Holter EKG; Other: Questionnaire | |
| Group 3 | Patients undergoing pulmonary veins isolation with PFA with paroxysmal AF, in sinus rhythm during the procedure. Receives: Procedure: ablation- pulmonary vain isolation- pulsed field ablation (PFA); Procedure: Electrophysiological study (EPS); Diagnostic Test: Holter EKG; Other: Questionnaire | |
| Group 4 | Patients undergoing RF ablation of the pulmonary veins using an electroanatomical system with paroxysmal AF, in sinus rhythm during the procedure. Receives: Procedure: ablation- pulmonary vain isolation- radiofrequency ablation (RF); Procedure: Electrophysiological study (EPS); Diagnostic Test: Holter EKG; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceleration and maintenance of a faster sinus rhythm after PVI
Based on EPS before and after PVI and Holter ECG before and after PVI and after 3 months of follow-up.
Measured: 3 months of follow-up
Improvement of AV conduction efficiency and its durability after PVI
Based on EPS before and after PVI and Holter ECG before and after PVI and after 3 months of follow-up.
Measured: 3 months of follow-up
Recurrence of AF during the observation period.
Based on Holter ECG and survey after 3 months of follow-up.
Measured: 3 months of follow-up
Secondary outcomes (1)
AF recurrence with the need to increase doses of heart rate control drugs.
Based on survey after 3 months of follow-up.
Measured: 3 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start23 Dec 2021
- Primary completion23 Dec 2023 (estimated)
- Study completion23 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- 4th Military Clinical Hospital with Polyclinic, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krystian Josiak, 4th Military Clinical Hospital with Polyclinic, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677516
- Sponsor's protocol ID
- UNCOVER-PVI
- Acronym
- UNCOVER-PVI
- Status last verified
- Dec 2022
- First submitted
- 23 Dec 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be collected in a database accessible only to the named researchers.
Publications
Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.
PubMed 32860505Katritsis DG, Pokushalov E, Romanov A, Giazitzoglou E, Siontis GC, Po SS, Camm AJ, Ioannidis JP. Autonomic denervation added to pulmonary vein isolation for paroxysmal atrial fibrillation: a randomized clinical trial. J Am Coll Cardiol. 2013 Dec 17;62(24):2318-25. doi: 10.1016/j.jacc.2013.06.053. Epub 2013 Aug 21.
PubMed 23973694Aksu T, Guler TE, Bozyel S, Yalin K, Gopinathannair R. Why is pulmonary vein isolation not enough for vagal denervation in all cases? Pacing Clin Electrophysiol. 2020 May;43(5):520-523. doi: 10.1111/pace.13922. Epub 2020 May 2.
PubMed 32324285Sakamoto S, Schuessler RB, Lee AM, Aziz A, Lall SC, Damiano RJ Jr. Vagal denervation and reinnervation after ablation of ganglionated plexi. J Thorac Cardiovasc Surg. 2010 Feb;139(2):444-52. doi: 10.1016/j.jtcvs.2009.04.056. Epub 2009 Sep 9.
PubMed 19740492Yorgun H, Aytemir K, Canpolat U, Sahiner L, Kaya EB, Oto A. Additional benefit of cryoballoon-based atrial fibrillation ablation beyond pulmonary vein isolation: modification of ganglionated plexi. Europace. 2014 May;16(5):645-51. doi: 10.1093/europace/eut240. Epub 2013 Aug 16.
PubMed 23954919
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Duration of Unintentional Neuromodulation Effects After Pulmonary Vein Isolation in Patients With Atrial Fibrillation. (UNCOVER-PVI)
- ClinicalTrials.gov ID
- NCT05677516
- Acronym / sponsor ID
- UNCOVER-PVI / UNCOVER-PVI
- Conditions
- Atrial Fibrillation
- Keywords
- pulmonary vains isolation, catdioneuroablation, cardioneuromodultion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- 4th Military Clinical Hospital with Polyclinic, PolandUniversity, hospital or other
- Study start
- 23 Dec 2021 (actual)
- Primary completion
- 23 Dec 2023 (estimated)
- Study completion
- 23 Dec 2023 (estimated)
- First posted
- 10 Jan 2023 (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.
Pulmonary vein isolation (PVI) is a proven, high-efficiency treatment for atrial fibrillation (AF). Performed, among others, using cryoablation, pulsed field ablation (PFA) or radiofrequency (RF) ablation. It has been shown that its effectiveness significantly increases when the PVI procedure is combined with cardioneuroablation (CNA). The autonomic nervous system - ganglionated plexi (GP), the target of the CNA, are the endings of the vagal nerve and are located in the neighborhood of the pulmonary veins ostia. Places that, in many cases, are unintentionally damaged during PVI. Varying degrees of injury to the GP during PVI indicate that the group of patients undergoing PVI is heterogeneous in this regard, and the effectiveness of PVI may vary. Vagal nerve endings damage during CNA abolishes or modifies its activity, which is manifested by the acceleration of sinus rhythm and increased atrioventricular conduction efficiency. Unintended CNA is not observed in every PVI procedure. The severity of the unintended CNA effect and its duration also vary.
THE STUDY OBJECTIVES:
- Frequency of unintentional CNA occurrence during PVI
- Duration effect of CNA after unintentional CNA
- Evaluation of the relationship between the different kinds of energy - cryo, pulsed field) and RFwith the unintentional CNA frequency occurrence and durability effect
- Clinical significance evaluation of the new assessment method of the CNA effectiveness with the measure of the cSNRT and the sinus rate after its return, measured before and after PVI
- Assessment of clinical significance for CNA evaluation of the electrophysiological parameters of AV node conduction efficiency, such as PQ interval, AH interval, HV interval, and Wenckebach's point. Parameters will be examined before and after PVI.
- PVI efficacy evaluation with the AF and Sick Sinus Syndrome treatment, especially with the elimination of the indications for the PM implantation (sinus bradycardia, AV conduction disorders)
- Assessment of sinus rhythm maintenance after PVI with unintentional CNA and without unintentional CNA
- Assessment of ventricular rate control during AF burden after unintentional CNA
- The search for new parameters evaluating the effectiveness and degree of CNA, such as the change in SR frequency after its return, may prove helpful and allow for resignation or significantly reduce the use of the complicated protocol of extracardiac vagal ganglion stimulation (ECVS) as a method to verify the effectiveness CNAs.
Detailed description
This is a multi-centre, prospective, observational study, which will include patients with paroxysmal or persistent atrial fibrillation qualified for PVI by the European Society of Cardiology guidelines. Pulmonary veins will be isolated with three kinds of energies: cryo, pulsed field and RF. The study group will consist of four subgroups:
- Patients undergoing cryoablation of pulmonary veins with paroxysmal or persistent AF with ongoing AF during ablation
- Patients undergoing cryoablation of pulmonary veins with paroxysmal AF, in sinus rhythm during the procedure
- Patients undergoing pulmonary veins isolation with PFA with paroxysmal AF, in sinus rhythm during the procedure
- Patients undergoing RF ablation of the pulmonary veins using an electroanatomical system with paroxysmal AF, in sinus rhythm during the procedure
The effect of unintentional neuromodulation will be assessed based on the following:
- ECG Holter monitoring performed before and after the procedure in all groups
- Parameters assessed in EPS before and after the procedure in groups 2,3, and 4.
The long-term effect of neuromodulation and its impact on maintaining sinus rhythm will be assessed based on the following:
- The Holter ECG monitoring in groups 2,3, and 4.
- The interview in all groups after three months of observation.
PROTOCOL STUDY:
GROUP 1:
- Holter ECG prior to PVI
- Holter ECG after PVI
- Survey after three months of observation.
GROUPS 2,3 AND 4:
- Holter ECG prior to PVI
- EPS prior to PVI
- EPS after PVI
- Holter ECG prior to PVI
- Holter ECG after three to six months of observation
- Survey after three months of observation.
All the measured parameters as well as demographic and clinical data will be recorded in the study database.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: ablation- pulmonary vain isolation- crioablation, Procedure: Electrophysiological study (EPS), Diagnostic Test: Holter EKG, Other: QuestionnairePatients undergoing cryoablation of pulmonary veins with paroxysmal or persistent AF with ongoing AF during ablation. |
| Group 2 | – | Procedure: ablation- pulmonary vain isolation- crioablation, Procedure: Electrophysiological study (EPS), Diagnostic Test: Holter EKG, Other: QuestionnairePatients undergoing cryoablation of pulmonary veins with paroxysmal AF, in sinus rhythm during the procedure. |
| Group 3 | – | Procedure: ablation- pulmonary vain isolation- pulsed field ablation (PFA), Procedure: Electrophysiological study (EPS), Diagnostic Test: Holter EKG, Other: QuestionnairePatients undergoing pulmonary veins isolation with PFA with paroxysmal AF, in sinus rhythm during the procedure. |
| Group 4 | – | Procedure: ablation- pulmonary vain isolation- radiofrequency ablation (RF), Procedure: Electrophysiological study (EPS), Diagnostic Test: Holter EKG, Other: QuestionnairePatients undergoing RF ablation of the pulmonary veins using an electroanatomical system with paroxysmal AF, in sinus rhythm during the procedure. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study group will consist of patients aged 18-85. With paroxysmal or persistent atrial fibrillation. Qualified for PVI according to the guidelines of the European Society of Cardiology.
Key inclusion criteria (2 listed)
- Patients qualified for PVI due to paroxysmal or persistent atrial fibrillation.
- Signed and dated written informed consent prior to admission to the trial.
Key exclusion criteria (6 listed)
- Any underwent cardiac ablation.
- A history of cardiac surgery.
- Pregnancy.
- Diseases affecting the autonomic nervous system.
- Change in heart rhythm during PVI, with no conversion to the primary rhythm at the end of the procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ablation- pulmonary vain isolation- crioablationPulmonary vein isolation is the electrical isolation of the pulmonary veins from the left atrium. It can be performed using the cryoablation technique. The procedure begins with venous access through the femoral vein through which catheters and electrodes are inserted. Then, the left atrium is accessed through a transseptal puncture and the pulmonary veins are isolated using a cryoablation balloon. Cryoablation procedures are performed under local anesthesia. The procedure is performed using X-ray fluoroscopy. | Procedure or surgery | Group 1, Group 2 |
| ablation- pulmonary vain isolation- pulsed field ablation (PFA)Pulmonary vein isolation is the electrical isolation of the pulmonary veins from the left atrium. It can be performed using the pulsed field ablation (PFA) technique. The procedure begins with venous access through the femoral vein through which catheters and electrodes are inserted. Then, the left atrium is accessed through a transseptal puncture and the pulmonary veins are isolated with a PFA electrode. PFA procedures are performed under general anesthesia. The procedure is performed using X-ray fluoroscopy. | Procedure or surgery | Group 3 |
| ablation- pulmonary vain isolation- radiofrequency ablation (RF)Pulmonary vein isolation is the electrical isolation of the pulmonary veins from the left atrium. It can be performed using the radiofrequency ablation (RF) technique. The procedure begins with venous access through the femoral vein through which catheters and electrodes are inserted. Then, the left atrium is accessed through a transseptal puncture and the pulmonary veins are isolated with a RF electrode. RF procedures are performed under local anesthesia. The procedure is performed using X-ray fluoroscopy. | Procedure or surgery | Group 4 |
| Electrophysiological study (EPS)In the electrophysiological study (EPS), electrophysiological parameters such as the recovery time of sinus rhythm (SNRT), Wenckebach's point, AH and HV intervals are measured. The examination begins with venous access through the femoral vein. Then, diagnostic electrodes are inserted into the right atrium, right ventricle and coronary sinus, with which electrophysiological tests are performed. The SNRT is measured after 60 seconds of atrial pacing with a 600ms cycle. The Wencjabach point is determined by stimulation in the incremental protocol. AV and HV intervals are measured during sinus rhythm using an electrode placed on the bundle of His. EPS is performed under local anesthesia. EPS will be performed both before and after pulmonary vein isolation. In patients with atrial fibrillation, during ablation, only the HV interval will be measured. The procedure is performed using X-ray fluoroscopy. | Procedure or surgery | Group 1, Group 2, Group 3, Group 4 |
| Holter EKGHolter ECG is a 24-hour, non-invasive ECG recording using a portable recorder and electrodes placed on the patient's chest. The Holter ECG will be performed three times: on the day preceding and on the first day after pulmonary veins isolation, and after 3 months of observation. | Diagnostic test | Group 1, Group 2, Group 3, Group 4 |
| QuestionnaireThe survey will be conducted after 3 months of observation and will include questions about the number of hospitalizations due to atrial fibrillation, heart palpitations, changes in pharmacotherapy. | Other | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Acceleration and maintenance of a faster sinus rhythm after PVI
Time frame: 3 months of follow-up
Based on EPS before and after PVI and Holter ECG before and after PVI and after 3 months of follow-up.
Improvement of AV conduction efficiency and its durability after PVI
Time frame: 3 months of follow-up
Based on EPS before and after PVI and Holter ECG before and after PVI and after 3 months of follow-up.
Recurrence of AF during the observation period.
Time frame: 3 months of follow-up
Based on Holter ECG and survey after 3 months of follow-up.
1 secondary outcome
AF recurrence with the need to increase doses of heart rate control drugs.
Time frame: 3 months of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Background: PubMed 32860505Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.
- Background: PubMed 23973694Katritsis DG, Pokushalov E, Romanov A, Giazitzoglou E, Siontis GC, Po SS, Camm AJ, Ioannidis JP. Autonomic denervation added to pulmonary vein isolation for paroxysmal atrial fibrillation: a randomized clinical trial. J Am Coll Cardiol. 2013 Dec 17;62(24):2318-25. doi: 10.1016/j.jacc.2013.06.053. Epub 2013 Aug 21.
- Background: PubMed 32324285Aksu T, Guler TE, Bozyel S, Yalin K, Gopinathannair R. Why is pulmonary vein isolation not enough for vagal denervation in all cases? Pacing Clin Electrophysiol. 2020 May;43(5):520-523. doi: 10.1111/pace.13922. Epub 2020 May 2.
- Background: PubMed 19740492Sakamoto S, Schuessler RB, Lee AM, Aziz A, Lall SC, Damiano RJ Jr. Vagal denervation and reinnervation after ablation of ganglionated plexi. J Thorac Cardiovasc Surg. 2010 Feb;139(2):444-52. doi: 10.1016/j.jtcvs.2009.04.056. Epub 2009 Sep 9.
- Background: PubMed 23954919Yorgun H, Aytemir K, Canpolat U, Sahiner L, Kaya EB, Oto A. Additional benefit of cryoballoon-based atrial fibrillation ablation beyond pulmonary vein isolation: modification of ganglionated plexi. Europace. 2014 May;16(5):645-51. doi: 10.1093/europace/eut240. Epub 2013 Aug 16.
- Individual participant dataSharing planned: No. The data will be collected in a database accessible only to the named researchers.
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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. This study is not recruiting at the moment.
2 sites 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, run by 4th Military Clinical Hospital with Polyclinic, Poland at 2 sites in Poland.
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 2 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: status not confirmed, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Przemysław Skoczyński, PhD (+48602753043, przeskocz@tlen.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceleration and maintenance of a faster sinus rhythm after PVI (time frame: 3 months of follow-up). 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 NCT05677516, which also lists 5 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 10 Jan 2023.