Persistent Atrial FibrillationPhase 4NCT07877116
Sevoflurane Versus Propofol Anesthesia in Intracardiac Echocardiography-Guided Atrial Fibrillation Ablation
A Phase 4 study testing Sevoflurane and propofol in people with Persistent Atrial Fibrillation, run by Hüseyin Ulaş Pinar at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, single-center study will compare sevoflurane inhalational anesthesia with propofol intravenous anesthesia in patients undergoing intracardiac echocardiography-guided radiofrequency catheter ablation for atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Sevoflurane and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to Apr 2027
- Phase
- Phase 4
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with atrial fibrillation who are scheduled to undergo elective intracardiac echocardiography-guided radiofrequency catheter ablation.
- Patients aged 18 to 64 years who provide informed consent to participate in the study.
- Patients aged 65 to 90 years with a Mini-Mental State Examination score of 24 or higher who provide informed consent to participate in the study.
Who cannot join
- Known allergy to propofol.
- Known allergy to sevoflurane.
- Left ventricular ejection fraction below 35%.
- Previous catheter ablation.
- Emergency ablation procedure.
- Refusal to provide informed consent for study participation.
- Patients aged 65 to 90 years with a Mini-Mental State Examination score below 24.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Medicine, Department of Anesthesiology and Reanimation
Ankara, Ankara, 06230
Hüseyin Ulaş Pınar, MD, +90 5055251992, huseyinpinar2002@yahoo.com
Hüseyin Ulaş Pınar, MD
About this study
Official title: Comparison of Inhalational Anesthesia and Intravenous Anesthesia as General Anesthesia Management in Intracardiac Echocardiography-Guided Radiofrequency Catheter Ablation Procedures in Patients With Atrial Fibrillation in Terms of Acute Procedural Success and Early Atrial Arrhythmia Recurrence
This prospective, randomized, single-center study will compare sevoflurane inhalational anesthesia with propofol intravenous anesthesia in patients undergoing intracardiac echocardiography-guided radiofrequency catheter ablation for atrial fibrillation. Eligible participants will be randomly assigned to one of two general anesthesia groups. In the sevoflurane group, anesthesia will be maintained with sevoflurane, while in the propofol group, anesthesia will be maintained with propofol administered using target-controlled infusion. In both groups, anesthesia depth will be adjusted to maintain a Bispectral Index value between 40 and 60. The study will evaluate acute procedural success and atrial arrhythmia recurrence at 6 months. Additional outcomes will include mapping time, ablation time, total procedure time, hemodynamic instability, recovery score, and procedural complications.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Sevoflurane, propofol
- Keywords
- Intracardiac Echocardiography, Radiofrequency Catheter Ablation, Atrial Arrhythmia Recurrence, Bispectral Index, General Anesthesia, Sevoflurane, propofol
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Sevoflurane will be used for maintenance of general anesthesia. General anesthesia will be induced with propofol 2 mg/kg, and the sevoflurane dose will be adjusted to maintain a Bispectral Index (BIS) value between 40 and 60.
propofolDrug
Propofol will be administered using target-controlled infusion (TCI), with an initial plasma target concentration of 4 mcg/mL. General anesthesia will be maintained with propofol, adjusted to maintain a Bispectral Index (BIS) value between 40 and 60.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane Inhalational Anesthesia | Experimental | Participants in this arm will receive general anesthesia induction with propofol 2 mg/kg. Anesthesia will be maintained with sevoflurane, and the sevoflurane dose will be adjusted to maintain a Bispectral Index (BIS) value between 40 and 60. Receives: Drug: Sevoflurane |
| Propofol Intravenous Anesthesia | Active comparator | articipants in this arm will receive propofol using target-controlled infusion (TCI), with an initial plasma target concentration of 4 mcg/mL. Anesthesia will be maintained with propofol, adjusted to maintain a Bispectral Index (BIS) value between 40 and 60. Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial Tachyarrhythmia Recurrence at 6 Months
The proportion of participants with atrial tachyarrhythmia recurrence at 6 months after radiofrequency catheter ablation will be assessed during routine cardiology follow-up and obtained from medical records.
Measured: From the date of the ablation procedure through 6 months after the procedure
Secondary outcomes (7)
Acute Procedural Success
The proportion of participants in whom the radiofrequency catheter ablation procedure is successfully completed as intended at the end of the procedure will be assessed.
Measured: At the end of the ablation procedure
Mapping Time
Mapping time during the radiofrequency catheter ablation procedure will be recorded from the intraoperative procedure records.
Measured: During the ablation procedure
Ablation Time
Ablation time during the radiofrequency catheter ablation procedure will be recorded from the intraoperative procedure records.
Measured: During the ablation procedure
Total Procedure Time
Total procedure time for the radiofrequency catheter ablation procedure will be recorded from the intraoperative procedure records.
Measured: During the ablation procedure
Hemodynamic Instability
Hemodynamic instability during the procedure will be assessed from intraoperative anesthesia records. Mean arterial pressure will be recorded during the procedure.
Measured: During the ablation procedure
Change in Quality of Recovery-15 (QoR-15) Score at 24 Hours
Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire preoperatively and at 24 hours after the procedure. Each of the 15 items is scored from 0 to 10, with higher scores indicating better recovery.
Measured: Preoperatively and 24 hours after the procedure
Procedural Complications
The proportion of participants experiencing procedural complications will be assessed based on intraoperative procedure and anesthesia records.
Measured: 1. During the ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hüseyin Ulaş Pinar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hüseyin Ulaş Pinar, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877116
- Sponsor's protocol ID
- KA-26018
- Other IDs
- 26-AKD-287
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No