Paroxysmal Atrial FibrillationPULSE-SEDNCT07877519
Conscious Sedation Versus General Anesthesia for Pulsed Field Ablation in Paroxysmal Atrial Fibrillation
A study testing Local Anesthesia With Conscious Sedation, General Anesthesia and VARIPULSE Pulsed Field Ablation System in people with Paroxysmal Atrial Fibrillation, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This prospective, multicenter, randomized, controlled, noninferiority trial will compare local anesthesia with conscious sedation and general anesthesia in patients undergoing pulsed field ablation for paroxysmal atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Local Anesthesia With Conscious Sedation, General Anesthesia and VARIPULSE Pulsed Field Ablation System
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to Jun 2028
- Phase
- Interventional
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of paroxysmal atrial fibrillation.
- Age 18 to 80 years.
- Scheduled and willing to undergo pulsed field ablation.
- American Society of Anesthesiologists physical status class I to III.
- Able to understand the study procedures and provide written informed consent.
Who cannot join
- Contraindication to catheter ablation, including intracardiac or atrial thrombus.
- Previous catheter ablation for atrial fibrillation or left atrial premature contractions.
- Known allergy to iodinated contrast media.
- Concurrent participation in another clinical trial involving a drug or medical device.
- Pregnancy, breastfeeding, or planned pregnancy in the near future.
- Active infection.
- Unwilling to participate or unable to comply with the study procedures and scheduled follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037
Guanzhi Chen, Doctor, +8613923975318, chenguanzhi@fuwai.com
Ligang Ding, Doctor, ligangding@263.net
About this study
Official title: Efficacy and Safety of Local Anesthesia With Conscious Sedation Versus General Anesthesia for Pulsed Field Ablation in Patients With Paroxysmal Atrial Fibrillation: A Prospective, Multicenter, Randomized, Controlled, Noninferiority Trial
This prospective, multicenter, randomized, controlled, noninferiority trial will compare local anesthesia with conscious sedation and general anesthesia in patients undergoing pulsed field ablation for paroxysmal atrial fibrillation.
A total of 390 participants aged 18 to 80 years will be randomly assigned in a 1:1 ratio to undergo pulsed field ablation under either local anesthesia with conscious sedation or general anesthesia. Both groups will receive pulmonary vein isolation using the same pulsed field ablation strategy.
Read more
The primary outcome is recurrence of an electrocardiographically documented atrial tachyarrhythmia after an 8-week post-ablation blanking period. Recurrence is defined as atrial fibrillation, atrial flutter, or atrial tachycardia lasting at least 30 seconds through 12 months after ablation.
The study will also compare the ability of each anesthesia strategy to support successful completion of the ablation procedure, anesthesia-related and ablation-related complications, procedural efficiency, patient-reported pain and anxiety, overall procedural experience, and direct medical costs.
Read the detailed description
Pulsed field ablation is an emerging catheter ablation technology for the treatment of atrial fibrillation. Delivery of pulsed field energy may cause chest discomfort, coughing, involuntary movement, and phrenic nerve stimulation. General anesthesia is therefore commonly used to improve participant tolerance and facilitate catheter stability during the procedure. However, general anesthesia requires dedicated anesthesia personnel and resources and may prolong preprocedural preparation and postprocedural recovery.
Local anesthesia combined with conscious sedation may provide a simpler alternative for pulsed field ablation. This strategy may reduce the need for anesthesia resources while maintaining participant safety and procedural effectiveness. However, high-quality evidence directly comparing local anesthesia with conscious sedation and general anesthesia during pulsed field ablation remains limited.
This study is a prospective, multicenter, randomized, controlled, noninferiority trial designed to compare the efficacy and safety of the two anesthesia strategies in participants with paroxysmal atrial fibrillation. A total of 390 eligible participants will be randomly assigned in a 1:1 ratio to either local anesthesia with conscious sedation or general anesthesia. The randomization sequence will be generated by an independent statistician using computer-based block randomization.
Participants assigned to the local anesthesia with conscious sedation group will receive protocol-specified antitussive pretreatment, local anesthesia, analgesia, and conscious sedation. Additional sedative or analgesic medication may be administered according to vital signs, pain, coughing, agitation, and clinical tolerance. Participants who experience persistent severe coughing or agitation, respiratory depression or refractory hypoxemia, uncorrectable hemodynamic instability, or an inability to tolerate the assigned strategy may be converted to general anesthesia. Participants who are converted to general anesthesia will remain in their originally assigned group for the primary intention-to-treat analysis.
Participants assigned to the general anesthesia group will receive general anesthesia administered and managed by an anesthesiologist according to the clinical practice of the participating center.
All participants will undergo bilateral pulmonary vein isolation using the VARIPULSE pulsed field ablation catheter under CARTO 3 electroanatomic mapping guidance. Additional ablation of the left atrial posterior wall, superior vena cava, or other atrial substrate may be performed when clinically indicated. Activated clotting time will be maintained at 350 seconds or longer during left atrial ablation.
Participants will be followed at 1, 2, 3, 6, and 12 months after ablation. Wearable electrocardiographic monitoring will be performed for at least 7 days at each scheduled follow-up. The first 8 weeks after ablation will be considered the blanking period.
The primary outcome is recurrence of an electrocardiographically documented atrial tachyarrhythmia, defined as atrial fibrillation, atrial flutter, or atrial tachycardia lasting at least 30 seconds after the 8-week blanking period through 12 months after ablation. The primary analysis will evaluate whether local anesthesia with conscious sedation is noninferior to general anesthesia, using a prespecified absolute noninferiority margin of 13 percentage points.
Secondary outcomes include successful completion of the planned ablation procedure with support from the assigned anesthesia strategy, conversion from conscious sedation to general anesthesia, anesthesia-related adverse events, ablation-related complications, acute pulmonary vein isolation success, procedure and recovery times, fluoroscopy time, participant-reported pain and anxiety, overall procedural experience, and direct anesthesia- or sedation-related medical costs.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Local Anesthesia With Conscious Sedation, General Anesthesia, VARIPULSE Pulsed Field Ablation System, Compound methoxyphenamine capsules, Salbutamol
- Keywords
- Pulsed Field Ablation, Conscious Sedation, General Anesthesia, Local Anesthesia, Catheter Ablation, Pulmonary Vein Isolation, Noninferiority Trial, VARIPULSE
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Anesthesia With Conscious SedationProcedure or surgery
Protocol-specified antitussive pretreatment is followed by local anesthesia, analgesia, and conscious sedation. Before femoral venous puncture, intravenous tropisetron hydrochloride 5 mg, dexamethasone 5 mg, lidocaine 100 mg over 10 minutes, fentanyl 50 micrograms, midazolam 2 mg, and atropine 1 mg are given. After transseptal puncture, fentanyl 50-100 micrograms is given intravenously, followed by 0.04 micrograms/kg/min infusion. Additional midazolam or fentanyl may be given according to vital signs and clinical tolerance. Conversion to general anesthesia is permitted for persistent severe coughing, pain, anxiety, or agitation interfering with catheter positioning or energy delivery; persistent respiratory depression or refractory hypoxemia; uncorrectable hemodynamic instability; or inability or unwillingness to tolerate the assigned strategy.
General AnesthesiaProcedure or surgery
General anesthesia will be induced, maintained, and monitored by an anesthesiologist according to routine clinical practice at each participating center. Airway management, anesthetic medications, ventilation parameters, hemodynamic management, and post-anesthesia recovery will be documented.
VARIPULSE Pulsed Field Ablation SystemDevice
All participants will undergo bilateral pulmonary vein isolation using the VARIPULSE pulsed field ablation catheter under CARTO 3 electroanatomic mapping guidance. Additional ablation of the left atrial posterior wall, superior vena cava, or other atrial substrate may be performed when clinically indicated. Bidirectional pulmonary vein isolation will be evaluated at the end of the procedure. Activated clotting time will be maintained at 350 seconds or longer during left atrial ablation.
Compound methoxyphenamine capsulesDrug
Oral antitussive pretreatment with compound methoxyphenamine capsules (Asmeton) during the 24 hours before the procedure, as specified in the protocol.
SalbutamolDrug
Nebulized pretreatment in combination with budesonide and lidocaine within 90 minutes before the procedure, as specified in the protocol for the local anesthesia with conscious sedation arm.
BudesonideDrug
Nebulized pretreatment in combination with salbutamol and lidocaine within 90 minutes before the procedure, as specified in the protocol for the local anesthesia with conscious sedation arm.
LidocaineDrug
Administered by nebulization with salbutamol and budesonide within 90 minutes before the procedure, and intravenously before femoral venous puncture, as specified in the protocol for the local anesthesia with conscious sedation arm.
FentanylDrug
For the local anesthesia with conscious sedation arm: intravenous fentanyl 50 micrograms before femoral venous puncture, followed by 50 to 100 micrograms after transseptal puncture and a continuous intravenous infusion at 0.04 micrograms/kg/min. Additional doses may be administered according to vital signs, pain, and clinical tolerance, as specified in the protocol.
MidazolamDrug
For the local anesthesia with conscious sedation arm: intravenous midazolam 2 mg before femoral venous puncture. Additional doses may be given according to vital signs and clinical response, as specified in the protocol.
Tropisetron hydrochlorideDrug
Intravenous tropisetron hydrochloride 5 mg before femoral venous puncture as part of the protocol-specified premedication regimen for the local anesthesia with conscious sedation arm.
DexamethasoneDrug
Intravenous dexamethasone 5 mg before femoral venous puncture as part of the protocol-specified premedication regimen for the local anesthesia with conscious sedation arm.
AtropineDrug
Intravenous atropine 1 mg before femoral venous puncture as part of the protocol-specified premedication regimen for the local anesthesia with conscious sedation arm.
| Study group | Role | What they receive |
|---|---|---|
| Local Anesthesia With Conscious Sedation | Experimental | Participants assigned to this arm will undergo pulsed field ablation under local anesthesia with conscious sedation and protocol-specified antitussive pretreatment. Sedative and analgesic medications may be adjusted according to vital signs, pain, coughing, agitation, and clinical tolerance. Participants who meet prespecified intolerance or safety criteria may be converted to general anesthesia. Participants requiring conversion will remain in their originally assigned arm for the intention-to-treat analysis. Receives: Procedure: Local Anesthesia With Conscious Sedation; Device: VARIPULSE Pulsed Field Ablation System; Drug: Compound methoxyphenamine capsules; Drug: Salbutamol; Drug: Budesonide; Drug: Lidocaine; Drug: Fentanyl; Drug: Midazolam; Drug: Tropisetron hydrochloride; Drug: Dexamethasone; Drug: Atropine |
| General Anesthesia | Active comparator | Participants assigned to this arm will undergo pulsed field ablation under general anesthesia. General anesthesia will be administered and managed by an anesthesiologist according to routine clinical practice at each participating center. Receives: Procedure: General Anesthesia; Device: VARIPULSE Pulsed Field Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Recurrence of Atrial Tachyarrhythmia After the Blanking Period
Recurrence is defined as at least one episode of atrial fibrillation, atrial flutter, or atrial tachycardia lasting 30 seconds or longer and documented by electrocardiographic monitoring after the 8-week post-ablation blanking period. Rhythm monitoring will be performed using a wearable electrocardiographic device for at least 7 days at each scheduled follow-up. The outcome will be reported as the percentage of participants with recurrence.
Measured: From the end of the 8-week post-ablation blanking period through 12 months after the index ablation procedure
Secondary outcomes (15)
Percentage of Participants With Successful Procedural Support by the Assigned Anesthesia Strategy
Successful procedural support is defined as completion of the planned ablation strategy without an anesthesia-related event causing interruption, premature termination, or inability to complete the intended ablation strategy.
For participants assigned to local anesthesia with conscious sedation, success requires: (1) no interruption of ablation on three or more occasions because of severe coughing, pain, or agitation; (2) no single interruption lasting more than 5 minutes because of severe coughing, pain, or agitation; and (3) no conversion to general anesthesia because of intolerance of the assigned anesthesia strategy.
For participants assigned to general anesthesia, success requires no premature termination of the procedure because of hemodynamic instability, a severe allergic reaction, or another anesthesia-related event.
Measured: During the index ablation procedure
Percentage of Participants With Airway Mechanical Injury
The percentage of participants experiencing at least one airway mechanical injury, including sore throat, mucosal bleeding, or hoarseness, following the assigned anesthesia or sedation strategy. Individual components will also be recorded separately.
Measured: From initiation of anesthesia or sedation through discharge from the index hospitalization, an expected average of 2 days.
Percentage of Participants Requiring Conversion From Conscious Sedation to General Anesthesia
The percentage of participants assigned to local anesthesia with conscious sedation who require conversion to general anesthesia because of persistent severe coughing, pain, anxiety, or agitation interfering with catheter positioning or energy delivery; persistent respiratory depression or refractory hypoxemia; uncorrectable hemodynamic instability; or inability or unwillingness to tolerate the assigned anesthesia strategy.
Measured: During the index ablation procedure
Percentage of Participants With Intraoperative Agitation
The percentage of participants with intraoperative agitation documented by the procedural team during the index ablation procedure.
Measured: During the index ablation procedure
Duration of Procedural Area Occupancy
The elapsed time in minutes from the participant's entry into the procedural area, recorded by the first entry scan, to the participant's exit from the procedural area, recorded by the corresponding exit scan.
Measured: During the index procedure
Duration of Catheter Laboratory Occupancy
The elapsed time in minutes from the participant's entry into the catheter laboratory, recorded by the second entry scan, to the participant's exit from the catheter laboratory, recorded by the corresponding exit scan.
Measured: During the index procedure
Percentage of Participants With Acute Pulmonary Vein Isolation Success
The percentage of participants in whom bidirectional electrical isolation of all targeted pulmonary veins is confirmed at the end of the index ablation procedure.
Measured: At the end of the index ablation procedure
Pain Visual Analog Scale Score
Pain will be assessed using a 0-to-100 visual analog scale, where 0 indicates no pain and 100 indicates the worst imaginable pain. Higher scores indicate greater pain.
Measured: Immediately after the index ablation procedure
Anxiety Visual Analog Scale Score
Anxiety will be assessed using a 0-to-100 visual analog scale, where 0 indicates no anxiety and 100 indicates the worst imaginable anxiety. Higher scores indicate greater anxiety.
Measured: Immediately after the index ablation procedure
Overall Procedural Experience Visual Analog Scale Score
Overall procedural experience will be assessed using a 0-to-100 visual analog scale, where 0 indicates the worst possible procedural experience and 100 indicates the best possible procedural experience. Higher scores indicate a better procedural experience.
Measured: Immediately after the index ablation procedure
Direct Anesthesia- or Sedation-Related Supplies and Medication Cost
The total itemized cost in Chinese yuan of supplies and medications directly related to the assigned anesthesia or sedation strategy. Items may include laryngeal masks, anesthesia breathing circuits, anesthesia masks, respiratory filters, intravenous anesthetics, muscle relaxants, reversal agents, local anesthetics, nasal oxygen-delivery supplies, fentanyl, midazolam, dexmedetomidine, and lidocaine, as applicable.
Measured: During the index procedure and associated procedural preparation and recovery
Anesthesia- or Sedation-Related Monitoring and Service Cost
The total cost in Chinese yuan of anesthesia- or sedation-related monitoring and professional services, including respiratory function monitoring under general anesthesia and local anesthesia or sedation procedure fees, as applicable.
Measured: During the index procedure and associated procedural preparation and recovery
Ancillary and Rescue Care Cost
The total cost in Chinese yuan of ancillary and rescue care associated with the assigned anesthesia or sedation strategy, including oxygen therapy, intravenous access, pressure-monitoring catheters, oxygen sensors, supportive treatment, emergency treatment, and antiemetic medications.
Measured: During the index hospitalization, through discharge (expected an average of 2 days after initiation of anesthesia or sedation).
Percentage of Participants With Anesthesia-Related Adverse Events
The percentage of participants experiencing at least one prespecified anesthesia-related adverse event, including sore throat, mucosal bleeding, hoarseness, bradycardia, intraoperative hypotension, hypoxemia, postoperative cognitive dysfunction, or severe vomiting. Each component event will also be recorded and reported separately.
Measured: From initiation of anesthesia or sedation through 30 days after the index ablation procedure
Percentage of Participants With Ablation-Related Complications
The percentage of participants experiencing at least one prespecified ablation-related complication, including cardiac tamponade, pericardial effusion, coronary artery spasm, phrenic nerve injury, kidney injury, hemolysis, or vascular access complications. Each component event will also be recorded and reported separately.
Measured: From the index ablation procedure through 12 months after the 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 Jun 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to undergo pulsed field ablation under either local anesthesia with conscious sedation or general anesthesia. Both groups will receive the same pulsed field ablation strategy and will be followed for 12 months.
- Masking
- None (open label)
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ligang Ding, Study chair, Chinese Academy of Medical Sciences & Peking Union Medical College Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877519
- Sponsor's protocol ID
- PULSE-SED
- Acronym
- PULSE-SED
- Status last verified
- Oct 2026
- First submitted
- 19 Jul 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision regarding sharing deidentified individual participant data has not yet been finalized. Any future data sharing will require approval by the study investigators and relevant ethics committees, appropriate protection of participant privacy, and execution of a data-use agreement.
Publications
Iacopino S, Colella J, Dini D, Mantovani L, Sorrenti PF, Malacrida M, Filannino P. Sedation strategies for pulsed-field ablation of atrial fibrillation: focus on deep sedation with intravenous ketamine in spontaneous respiration. Europace. 2023 Aug 2;25(9):euad230. doi: 10.1093/europace/euad230.
PubMed 37494101Schmidt B, Bordignon S, Neven K, Reichlin T, Blaauw Y, Hansen J, Adelino R, Ouss A, Futing A, Roten L, Mulder BA, Ruwald MH, Mene R, van der Voort P, Reinsch N, Kueffer T, Boveda S, Albrecht EM, Schneider CW, Chun KRJ. EUropean real-world outcomes with Pulsed field ablatiOn in patients with symptomatic atRIAl fibrillation: lessons from the multi-centre EU-PORIA registry. Europace. 2023 Jul 4;25(7):euad185. doi: 10.1093/europace/euad185.
PubMed 37379528Garcia R, Waldmann V, Vanduynhoven P, Nesti M, Jansen de Oliveira Figueiredo M, Narayanan K, Conte G, Guerra JM, Boveda S, Duncker D. Worldwide sedation strategies for atrial fibrillation ablation: current status and evolution over the last decade. Europace. 2021 Dec 7;23(12):2039-2045. doi: 10.1093/europace/euab154.
PubMed 34308973Ekanem E, Reddy VY, Schmidt B, Reichlin T, Neven K, Metzner A, Hansen J, Blaauw Y, Maury P, Arentz T, Sommer P, Anic A, Anselme F, Boveda S, Deneke T, Willems S, van der Voort P, Tilz R, Funasako M, Scherr D, Wakili R, Steven D, Kautzner J, Vijgen J, Jais P, Petru J, Chun J, Roten L, Futing A, Rillig A, Mulder BA, Johannessen A, Rollin A, Lehrmann H, Sohns C, Jurisic Z, Savoure A, Combes S, Nentwich K, Gunawardene M, Ouss A, Kirstein B, Manninger M, Bohnen JE, Sultan A, Peichl P, Koopman P, Derval N, Turagam MK, Neuzil P; MANIFEST-PF Cooperative. Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF). Europace. 2022 Sep 1;24(8):1256-1266. doi: 10.1093/europace/euac050.
PubMed 35647644Reddy 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 33933412Reddy VY, Gerstenfeld EP, Natale A, Whang W, Cuoco FA, Patel C, Mountantonakis SE, Gibson DN, Harding JD, Ellis CR, Ellenbogen KA, DeLurgio DB, Osorio J, Achyutha AB, Schneider CW, Mugglin AS, Albrecht EM, Stein KM, Lehmann JW, Mansour M; ADVENT Investigators. Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2023 Nov 2;389(18):1660-1671. doi: 10.1056/NEJMoa2307291. Epub 2023 Aug 27.
PubMed 37634148Di Biase L, Diaz JC, Zhang XD, Romero J. Pulsed field catheter ablation in atrial fibrillation. Trends Cardiovasc Med. 2022 Aug;32(6):378-387. doi: 10.1016/j.tcm.2021.07.006. Epub 2021 Jul 28.
PubMed 34329732Parameswaran R, Al-Kaisey AM, Kalman JM. Catheter ablation for atrial fibrillation: current indications and evolving technologies. Nat Rev Cardiol. 2021 Mar;18(3):210-225. doi: 10.1038/s41569-020-00451-x. Epub 2020 Oct 13.
PubMed 33051613Packer DL, Mark DB, Robb RA, Monahan KH, Bahnson TD, Poole JE, Noseworthy PA, Rosenberg YD, Jeffries N, Mitchell LB, Flaker GC, Pokushalov E, Romanov A, Bunch TJ, Noelker G, Ardashev A, Revishvili A, Wilber DJ, Cappato R, Kuck KH, Hindricks G, Davies DW, Kowey PR, Naccarelli GV, Reiffel JA, Piccini JP, Silverstein AP, Al-Khalidi HR, Lee KL; CABANA Investigators. Effect of Catheter Ablation vs Antiarrhythmic Drug Therapy on Mortality, Stroke, Bleeding, and Cardiac Arrest Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial. JAMA. 2019 Apr 2;321(13):1261-1274. doi: 10.1001/jama.2019.0693.
PubMed 30874766Mark DB, Anstrom KJ, Sheng S, Piccini JP, Baloch KN, Monahan KH, Daniels MR, Bahnson TD, Poole JE, Rosenberg Y, Lee KL, Packer DL; CABANA Investigators. Effect of Catheter Ablation vs Medical Therapy on Quality of Life Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial. JAMA. 2019 Apr 2;321(13):1275-1285. doi: 10.1001/jama.2019.0692.
PubMed 30874716Kirchhof P, Camm AJ, Goette A, Brandes A, Eckardt L, Elvan A, Fetsch T, van Gelder IC, Haase D, Haegeli LM, Hamann F, Heidbuchel H, Hindricks G, Kautzner J, Kuck KH, Mont L, Ng GA, Rekosz J, Schoen N, Schotten U, Suling A, Taggeselle J, Themistoclakis S, Vettorazzi E, Vardas P, Wegscheider K, Willems S, Crijns HJGM, Breithardt G; EAST-AFNET 4 Trial Investigators. Early Rhythm-Control Therapy in Patients with Atrial Fibrillation. N Engl J Med. 2020 Oct 1;383(14):1305-1316. doi: 10.1056/NEJMoa2019422. Epub 2020 Aug 29.
PubMed 32865375Roth GA, Mensah GA, Johnson CO, Addolorato G, Ammirati E, Baddour LM, Barengo NC, Beaton AZ, Benjamin EJ, Benziger CP, Bonny A, Brauer M, Brodmann M, Cahill TJ, Carapetis J, Catapano AL, Chugh SS, Cooper LT, Coresh J, Criqui M, DeCleene N, Eagle KA, Emmons-Bell S, Feigin VL, Fernandez-Sola J, Fowkes G, Gakidou E, Grundy SM, He FJ, Howard G, Hu F, Inker L, Karthikeyan G, Kassebaum N, Koroshetz W, Lavie C, Lloyd-Jones D, Lu HS, Mirijello A, Temesgen AM, Mokdad A, Moran AE, Muntner P, Narula J, Neal B, Ntsekhe M, Moraes de Oliveira G, Otto C, Owolabi M, Pratt M, Rajagopalan S, Reitsma M, Ribeiro ALP, Rigotti N, Rodgers A, Sable C, Shakil S, Sliwa-Hahnle K, Stark B, Sundstrom J, Timpel P, Tleyjeh IM, Valgimigli M, Vos T, Whelton PK, Yacoub M, Zuhlke L, Murray C, Fuster V; GBD-NHLBI-JACC Global Burden of Cardiovascular Diseases Writing Group. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol. 2020 Dec 22;76(25):2982-3021. doi: 10.1016/j.jacc.2020.11.010.
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