- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06364215
Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation ((SMILE-AF))
April 19, 2024 updated by: Jorge E. Romero, MD, Brigham and Women's Hospital
Posterior Wall Substrate Modification Using Irreversible Electroporation for the Treatment of Paroxysmal Atrial Fibrillation
Compare the efficacy and safety between pulmonary vein isolation (PVI) alone versus PVI with left atrial (LA) posterior wall isolation (PWI) using pulsed-field ablation (PFA) in the treatment of patients with paroxysmal atrial fibrillation (PAF).
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
450
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Obadah Aloum, MD
- Phone Number: 6177325241
- Email: oaloum@bwh.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
Contact:
- Obadah Aloum, MD
- Phone Number: 617-525-7047
-
Contact:
- Fernando Moreno
- Phone Number: 6175257047
-
Principal Investigator:
- Jorge E Romero, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Age 21-90 years.
- Symptomatic PAF whether failed AAD or not.
- At least one symptomatic episode of PAF lasting <7 days, documented on electrocardiogram (ECG), Holter, ZioPatch, ILR, or smartwatch recording in the year prior to enrollment.
- Patients undergoing first time ablation for AF.
Exclusion Criteria:
- Persistent atrial fibrillation (PeAF) (> 7 days in duration).
- Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or other reversible non-cardiac cause.
- Previous surgical or catheter ablation of AF.
- Previous valve surgery, ventriculotomy, atriotomy, or presence of a mitral mechanical prosthetic or bioprosthetic valve.
- left atrial anteroposterior (LA AP) diameter >55 mm or indexed left atrium (LA) volume >48 ml/m2.
- Contraindications to oral or systemic anticoagulation.
- Previous thromboembolic event (including ischemic strokes and TIA) within the last 3 months.
- Previous myocardial infarction or percutaneous coronary intervention within the past 2 months.
- Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months (180 days).
- Pregnancy.
- History of PV stenosis.
- History of severe pulmonary hypertension.
- History of diaphragmatic paresis or hemi-paresis.
- History of heart transplantation.
- History of blood clotting or bleeding abnormalities.
- Life expectancy of less than 12 months.
- Presence of intracardiac thrombus.
- Complex congenital heart disease, including tetralogy of Fallot, ventricular septal defects, Ebstein's anomaly, systemic right ventricle, and transposition of the great arteries.
- Intracardiac or vascular abnormalities that preclude adequate catheter introduction or manipulation within the LA.
- Pacing dependent patients.
- Active malignancy or history of treated malignancy within 12 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma).
- Active systemic infection.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Pulmonary Vein Isolation (PVI)
Pulsed field ablation isolation of the pulmonary veins only.
|
Ablation of the pulmonary veins for the treatment of Paroxysmal Atrial Fibrillation using pulsed field ablation.
|
Active Comparator: Pulmonary Vein Isolation and Posterior Wall Isolation ( PVI+PWI)
Pulsed field ablation isolation of the pulmonary veins and the posterior wall of the left atrium.
|
Ablation of the pulmonary veins and the left atrium posterior wall for the treatment of Paroxysmal Atrial Fibrillation using pulsed field ablation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Procedural success, defined as freedom from of all documented atrial arrhythmias episodes after the 3-month blanking period.
Time Frame: 12 months
|
will be assessed by:
|
12 months
|
The primary safety endpoint is a composite of acute procedure-related complications and any other major adverse events within the 12 months following the ablation procedure.
Time Frame: 12 Months
|
All number of acute procedure-related complications will be reported and assessed including: atrio-esophageal fistula, cardiac perforation, pulmonary vein (PV) stenosis, acute kidney injury, phrenic nerve paralysis, thromboembolic events, stroke, or transient ischemic attacks (TIA), and other major adverse events within the 12 months following the ablation procedure: pericarditis cardiac tamponade pericardial effusion, coronary artery spasm, Vascular access complication/major bleeding, local hematoma, ecchymosis left atrium or vascular laceration
|
12 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Freedom from atrial arrhythmias medication
Time Frame: 12 Months
|
Time and dose of anti arrhythmic medications use will be compared between the two groups.
|
12 Months
|
Procedural time
Time Frame: 12 Months
|
procedural time will be compared among groups.
|
12 Months
|
Procedure-related Recurrencies
Time Frame: 12 Months
|
Rate of PV and PW reconnection in patients undergoing repeat ablation procedures for recurrence of AF.
|
12 Months
|
Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT).
Time Frame: 12 Months
|
It reports scores from 0 to 100.
A score of 0 corresponds to complete disability, while a score of 100 describes the highest level of QoL
|
12 Months
|
Use of amiodarone
Time Frame: 12 months
|
Number of patients using amiodarone, and duration of using it will be compared among groups.
|
12 months
|
Complications.
Time Frame: 12 Months.
|
Incidence of acute procedure-related complications and long-term procedure-related complication.
|
12 Months.
|
fluoroscopy time.
Time Frame: during 1-2 hours procedure.
|
fluoroscopy time will be asses between the two groups.
|
during 1-2 hours procedure.
|
Pulsed field ablation (PFA) applications during procedure.
Time Frame: During 1-2 hours procedure.
|
The PFA count will be compared by the two groups.
|
During 1-2 hours procedure.
|
first-pass pulmonary vein isolation (PVI).
Time Frame: During 1-2 hours procedure.
|
the rates of first pass PVI will be compared between the two groups.
|
During 1-2 hours procedure.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jorge E Romero, MD, Mass General Brigham
- Principal Investigator: William H Sauer, MD, Mass General Brigham
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Nattel S, Burstein B, Dobrev D. Atrial remodeling and atrial fibrillation: mechanisms and implications. Circ Arrhythm Electrophysiol. 2008 Apr;1(1):62-73. doi: 10.1161/CIRCEP.107.754564. No abstract available.
- Kuck KH, Brugada J, Furnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.
- Kirchhof 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.
- Reddy VY, Anic A, Koruth J, Petru J, Funasako M, Minami K, Breskovic T, Sikiric I, Dukkipati SR, Kawamura I, Neuzil P. Pulsed Field Ablation in Patients With Persistent Atrial Fibrillation. J Am Coll Cardiol. 2020 Sep 1;76(9):1068-1080. doi: 10.1016/j.jacc.2020.07.007.
- Stewart MT, Haines DE, Verma A, Kirchhof N, Barka N, Grassl E, Howard B. Intracardiac pulsed field ablation: Proof of feasibility in a chronic porcine model. Heart Rhythm. 2019 May;16(5):754-764. doi: 10.1016/j.hrthm.2018.10.030. Epub 2018 Oct 30.
- Reddy VY, Koruth J, Jais P, Petru J, Timko F, Skalsky I, Hebeler R, Labrousse L, Barandon L, Kralovec S, Funosako M, Mannuva BB, Sediva L, Neuzil P. Ablation of Atrial Fibrillation With Pulsed Electric Fields: An Ultra-Rapid, Tissue-Selective Modality for Cardiac Ablation. JACC Clin Electrophysiol. 2018 Aug;4(8):987-995. doi: 10.1016/j.jacep.2018.04.005. Epub 2018 May 11.
- Packer 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.
- Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.
- Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, Benjamin EJ, Gillum RF, Kim YH, McAnulty JH Jr, Zheng ZJ, Forouzanfar MH, Naghavi M, Mensah GA, Ezzati M, Murray CJ. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47. doi: 10.1161/CIRCULATIONAHA.113.005119. Epub 2013 Dec 17.
- Lim HS, Hocini M, Dubois R, Denis A, Derval N, Zellerhoff S, Yamashita S, Berte B, Mahida S, Komatsu Y, Daly M, Jesel L, Pomier C, Meillet V, Amraoui S, Shah AJ, Cochet H, Sacher F, Jais P, Haissaguerre M. Complexity and Distribution of Drivers in Relation to Duration of Persistent Atrial Fibrillation. J Am Coll Cardiol. 2017 Mar 14;69(10):1257-1269. doi: 10.1016/j.jacc.2017.01.014.
- Andrade JG, Wells GA, Deyell MW, Bennett M, Essebag V, Champagne J, Roux JF, Yung D, Skanes A, Khaykin Y, Morillo C, Jolly U, Novak P, Lockwood E, Amit G, Angaran P, Sapp J, Wardell S, Lauck S, Macle L, Verma A; EARLY-AF Investigators. Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation. N Engl J Med. 2021 Jan 28;384(4):305-315. doi: 10.1056/NEJMoa2029980. Epub 2020 Nov 16.
- Wazni OM, Dandamudi G, Sood N, Hoyt R, Tyler J, Durrani S, Niebauer M, Makati K, Halperin B, Gauri A, Morales G, Shao M, Cerkvenik J, Kaplon RE, Nissen SE; STOP AF First Trial Investigators. Cryoballoon Ablation as Initial Therapy for Atrial Fibrillation. N Engl J Med. 2021 Jan 28;384(4):316-324. doi: 10.1056/NEJMoa2029554. Epub 2020 Nov 16.
- DeLurgio DB, Crossen KJ, Gill J, Blauth C, Oza SR, Magnano AR, Mostovych MA, Halkos ME, Tschopp DR, Kerendi F, Taigen TL, Shults CC, Shah MH, Rajendra AB, Osorio J, Silver JS, Hook BG, Gilligan DM, Calkins H. Hybrid Convergent Procedure for the Treatment of Persistent and Long-Standing Persistent Atrial Fibrillation: Results of CONVERGE Clinical Trial. Circ Arrhythm Electrophysiol. 2020 Dec;13(12):e009288. doi: 10.1161/CIRCEP.120.009288. Epub 2020 Nov 13.
- Narayan SM, Krummen DE, Shivkumar K, Clopton P, Rappel WJ, Miller JM. Treatment of atrial fibrillation by the ablation of localized sources: CONFIRM (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation) trial. J Am Coll Cardiol. 2012 Aug 14;60(7):628-36. doi: 10.1016/j.jacc.2012.05.022. Epub 2012 Jul 18.
- Hong J, Stewart MT, Cheek DS, Francischelli DE, Kirchhof N. Cardiac ablation via electroporation. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:3381-4. doi: 10.1109/IEMBS.2009.5332816.
- Reddy VY, Anter E, Rackauskas G, Peichl P, Koruth JS, Petru J, Funasako M, Minami K, Natale A, Jais P, Nakagawa H, Marinskis G, Aidietis A, Kautzner J, Neuzil P. Lattice-Tip Focal Ablation Catheter That Toggles Between Radiofrequency and Pulsed Field Energy to Treat Atrial Fibrillation: A First-in-Human Trial. Circ Arrhythm Electrophysiol. 2020 Jun;13(6):e008718. doi: 10.1161/CIRCEP.120.008718. Epub 2020 May 8.
- Ekanem 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. Erratum In: Europace. 2023 Feb 16;25(2):449.
- Rahman F, Kwan GF, Benjamin EJ. Global epidemiology of atrial fibrillation. Nat Rev Cardiol. 2016 Jul 14;13(8):501. doi: 10.1038/nrcardio.2016.114. No abstract available.
- Chew DS, Jones KA, Loring Z, Black-Maier E, Noseworthy PA, Exner DV, Packer DL, Grant J, Mark DB, Piccini JP. Diagnosis-to-ablation time predicts recurrent atrial fibrillation and rehospitalization following catheter ablation. Heart Rhythm O2. 2021 Nov 19;3(1):23-31. doi: 10.1016/j.hroo.2021.11.012. eCollection 2022 Feb.
- Romero J, Gabr M, Alviz I, Briceno D, Diaz JC, Rodriguez D, Patel K, Polanco D, Trivedi C, Mohanty S, Della Rocca D, Lakkireddy D, Natale A, Di Biase L. Focal impulse and rotor modulation guided ablation versus pulmonary vein isolation for atrial fibrillation: A meta-analysis of head-to-head comparative studies. J Cardiovasc Electrophysiol. 2021 Jul;32(7):1822-1832. doi: 10.1111/jce.15036. Epub 2021 May 27.
- Atienza F, Almendral J, Jalife J, Zlochiver S, Ploutz-Snyder R, Torrecilla EG, Arenal A, Kalifa J, Fernandez-Aviles F, Berenfeld O. Real-time dominant frequency mapping and ablation of dominant frequency sites in atrial fibrillation with left-to-right frequency gradients predicts long-term maintenance of sinus rhythm. Heart Rhythm. 2009 Jan;6(1):33-40. doi: 10.1016/j.hrthm.2008.10.024. Epub 2008 Oct 22.
- Kistler PM, Chieng D, Sugumar H, Ling LH, Segan L, Azzopardi S, Al-Kaisey A, Parameswaran R, Anderson RD, Hawson J, Prabhu S, Voskoboinik A, Wong G, Morton JB, Pathik B, McLellan AJ, Lee G, Wong M, Finch S, Pathak RK, Raja DC, Sterns L, Ginks M, Reid CM, Sanders P, Kalman JM. Effect of Catheter Ablation Using Pulmonary Vein Isolation With vs Without Posterior Left Atrial Wall Isolation on Atrial Arrhythmia Recurrence in Patients With Persistent Atrial Fibrillation: The CAPLA Randomized Clinical Trial. JAMA. 2023 Jan 10;329(2):127-135. doi: 10.1001/jama.2022.23722.
- Markman TM, Hyman MC, Kumareswaran R, Arkles JS, Santangeli P, Schaller RD, Supple GE, Frankel DS, Riley MP, Lin D, Garcia F, Dixit S, Callans DJ, Marchlinski FE, Nazarian S. Durability of posterior wall isolation after catheter ablation among patients with recurrent atrial fibrillation. Heart Rhythm. 2020 Oct;17(10):1740-1744. doi: 10.1016/j.hrthm.2020.05.005. Epub 2020 May 7.
- Kumar P, Bamimore AM, Schwartz JD, Chung EH, Gehi AK, Kiser AC, Hummel JP, Mounsey JP. Challenges and Outcomes of Posterior Wall Isolation for Ablation of Atrial Fibrillation. J Am Heart Assoc. 2016 Sep 23;5(9):e003885. doi: 10.1161/JAHA.116.003885.
- Aryana A, Thiemann AM, Pujara DK, Cossette LL, Allen SL, Bowers MR, Gandhavadi M, Heath R, Trivedi AD, O'Neill PG, Ellis ER, d'Avila A. Pulmonary Vein Isolation With and Without Posterior Wall Isolation in Paroxysmal Atrial Fibrillation: IMPPROVE-PAF Trial. JACC Clin Electrophysiol. 2023 May;9(5):628-637. doi: 10.1016/j.jacep.2023.01.014. Epub 2023 Mar 22.
- Tovar O, Tung L. Electroporation of cardiac cell membranes with monophasic or biphasic rectangular pulses. Pacing Clin Electrophysiol. 1991 Nov;14(11 Pt 2):1887-92. doi: 10.1111/j.1540-8159.1991.tb02785.x.
- Nikolski VP, Efimov IR. Electroporation of the heart. Europace. 2005 Sep;7 Suppl 2:146-54. doi: 10.1016/j.eupc.2005.04.011.
- Fuller IA, Wood MA. Intramural coronary vasculature prevents transmural radiofrequency lesion formation: implications for linear ablation. Circulation. 2003 Apr 8;107(13):1797-803. doi: 10.1161/01.CIR.0000058705.97823.F4. Epub 2003 Mar 24.
- Lavee J, Onik G, Mikus P, Rubinsky B. A novel nonthermal energy source for surgical epicardial atrial ablation: irreversible electroporation. Heart Surg Forum. 2007;10(2):E162-7. doi: 10.1532/HSF98.20061202.
- Wittkampf FH, van Driel VJ, van Wessel H, Vink A, Hof IE, Grundeman PF, Hauer RN, Loh P. Feasibility of electroporation for the creation of pulmonary vein ostial lesions. J Cardiovasc Electrophysiol. 2011 Mar;22(3):302-9. doi: 10.1111/j.1540-8167.2010.01863.x.
- Wittkampf FH, van Driel VJ, van Wessel H, Neven KG, Grundeman PF, Vink A, Loh P, Doevendans PA. Myocardial lesion depth with circular electroporation ablation. Circ Arrhythm Electrophysiol. 2012 Jun 1;5(3):581-6. doi: 10.1161/CIRCEP.111.970079. Epub 2012 Apr 6.
- Cochet H, Nakatani Y, Sridi-Cheniti S, Cheniti G, Ramirez FD, Nakashima T, Eggert C, Schneider C, Viswanathan R, Derval N, Duchateau J, Pambrun T, Chauvel R, Reddy VY, Montaudon M, Laurent F, Sacher F, Hocini M, Haissaguerre M, Jais P. Pulsed field ablation selectively spares the oesophagus during pulmonary vein isolation for atrial fibrillation. Europace. 2021 Sep 8;23(9):1391-1399. doi: 10.1093/europace/euab090.
- Steiger NA, Romero JE. Pulsed-field ablation: What are the unknowns and when will they cease to concern us? J Cardiovasc Electrophysiol. 2022 Jul;33(7):1489-1493. doi: 10.1111/jce.15521. Epub 2022 May 25. No abstract available.
- Yavin H, Shapira-Daniels A, Barkagan M, Sroubek J, Shim D, Melidone R, Anter E. Pulsed Field Ablation Using a Lattice Electrode for Focal Energy Delivery: Biophysical Characterization, Lesion Durability, and Safety Evaluation. Circ Arrhythm Electrophysiol. 2020 Jun;13(6):e008580. doi: 10.1161/CIRCEP.120.008580. Epub 2020 May 6.
- Koruth JS, Kuroki K, Kawamura I, Stoffregen WC, Dukkipati SR, Neuzil P, Reddy VY. Focal Pulsed Field Ablation for Pulmonary Vein Isolation and Linear Atrial Lesions: A Preclinical Assessment of Safety and Durability. Circ Arrhythm Electrophysiol. 2020 Jun;13(6):e008716. doi: 10.1161/CIRCEP.120.008716. Epub 2020 May 6.
- Loh P, van Es R, Groen MHA, Neven K, Kassenberg W, Wittkampf FHM, Doevendans PA. Pulmonary Vein Isolation With Single Pulse Irreversible Electroporation: A First in Human Study in 10 Patients With Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2020 Oct;13(10):e008192. doi: 10.1161/CIRCEP.119.008192. Epub 2020 Sep 8.
- Tohoku S, Chun KRJ, Bordignon S, Chen S, Schaack D, Urbanek L, Ebrahimi R, Hirokami J, Bologna F, Schmidt B. Findings from repeat ablation using high-density mapping after pulmonary vein isolation with pulsed field ablation. Europace. 2023 Feb 16;25(2):433-440. doi: 10.1093/europace/euac211.
- Kawamura I, Neuzil P, Shivamurthy P, Kuroki K, Lam J, Musikantow D, Chu E, Turagam MK, Minami K, Funasako M, Petru J, Choudry S, Miller MA, Langan MN, Whang W, Dukkipati SR, Koruth JS, Reddy VY. How does the level of pulmonary venous isolation compare between pulsed field ablation and thermal energy ablation (radiofrequency, cryo, or laser)? Europace. 2021 Nov 8;23(11):1757-1766. doi: 10.1093/europace/euab150.
- Lee JM, Shim J, Park J, Yu HT, Kim TH, Park JK, Uhm JS, Kim JB, Joung B, Lee MH, Kim YH, Pak HN; POBI-AF Investigators. The Electrical Isolation of the Left Atrial Posterior Wall in Catheter Ablation of Persistent Atrial Fibrillation. JACC Clin Electrophysiol. 2019 Nov;5(11):1253-1261. doi: 10.1016/j.jacep.2019.08.021. Epub 2019 Oct 30. Erratum In: JACC Clin Electrophysiol. 2023 Jan;9(1):145.
- Aryana A, Allen SL, Pujara DK, Bowers MR, O'Neill PG, Yamauchi Y, Shigeta T, Vierra EC, Okishige K, Natale A. Concomitant Pulmonary Vein and Posterior Wall Isolation Using Cryoballoon With Adjunct Radiofrequency in Persistent Atrial Fibrillation. JACC Clin Electrophysiol. 2021 Feb;7(2):187-196. doi: 10.1016/j.jacep.2020.08.016. Epub 2020 Oct 28.
- Ahn J, Shin DG, Han SJ, Lim HE. Does isolation of the left atrial posterior wall using cryoballoon ablation improve clinical outcomes in patients with persistent atrial fibrillation? A prospective randomized controlled trial. Europace. 2022 Jul 21;24(7):1093-1101. doi: 10.1093/europace/euac005.
- Abhayaratna WP, Seward JB, Appleton CP, Douglas PS, Oh JK, Tajik AJ, Tsang TS. Left atrial size: physiologic determinants and clinical applications. J Am Coll Cardiol. 2006 Jun 20;47(12):2357-63. doi: 10.1016/j.jacc.2006.02.048.
- Castiello T, Georgiopoulos G, Finocchiaro G, Claudia M, Gianatti A, Delialis D, Aimo A, Prasad S. COVID-19 and myocarditis: a systematic review and overview of current challenges. Heart Fail Rev. 2022 Jan;27(1):251-261. doi: 10.1007/s10741-021-10087-9. Epub 2021 Mar 24.
- Huo Y, Gaspar T, Schonbauer R, Wojcik M, Fiedler L, Roithinger FX, Martinek M, Purerfellner H, Kirstein B, Richter U, Ulbrich S, Mayer J, Krahnefeld O, Agdirlioglu T, Zedda A, Piorkowski J, Piorkowski C. Low-Voltage Myocardium-Guided Ablation Trial of Persistent Atrial Fibrillation. NEJM Evid. 2022 Nov;1(11):EVIDoa2200141. doi: 10.1056/EVIDoa2200141. Epub 2022 Oct 19.
- Romero J, Polanco D, Gabr M, Alviz I, Diaz JC, Briceno D, Velasco A, Patel K, Natale A, Di Biase L. Posterior Wall Electrical Isolation in Patients Undergoing Catheter Ablation for Paroxysmal and Nonparoxysmal Atrial Fibrillation. JACC Clin Electrophysiol. 2023 Apr;9(4):583-585. doi: 10.1016/j.jacep.2022.11.007. Epub 2023 Jan 18. No abstract available.
- Turagam MK, Neuzil P, 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, Lemoine MD, Ruwald M, Mulder BA, Rollin A, Lehrmann H, Fink T, Jurisic Z, Chaumont C, Adelino R, Nentwich K, Gunawardene M, Ouss A, Heeger CH, Manninger M, Bohnen JE, Sultan A, Peichl P, Koopman P, Derval N, Kueffer T, Rahe G, Reddy VY. Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry. Circulation. 2023 Jul 4;148(1):35-46. doi: 10.1161/CIRCULATIONAHA.123.064959. Epub 2023 May 18.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2024
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
April 8, 2024
First Submitted That Met QC Criteria
April 11, 2024
First Posted (Actual)
April 15, 2024
Study Record Updates
Last Update Posted (Actual)
April 22, 2024
Last Update Submitted That Met QC Criteria
April 19, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024P000883
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atrial Fibrillation Paroxysmal
-
Medtronic Cardiac Rhythm and Heart FailureCompletedParoxysmal Atrial Fibrillation (PAF)United States, Canada
-
Biosense Webster, Inc.Active, not recruitingRefractory Paroxysmal Atrial FibrillationChina
-
Boston Scientific CorporationCompletedParoxysmal Atrial Fibrillation (PAF)United States, Spain, Germany, Australia, United Kingdom, Sweden, Czechia, France, Portugal
-
Charite University, Berlin, GermanyGerman Federal Ministry of Education and ResearchTerminatedSymptomatic Paroxysmal Atrial FibrillationGermany
-
Biosense Webster, Inc.RecruitingDrug Refractory Paroxysmal Atrial FibrillationUnited States
-
Hospital Clinic of BarcelonaCompletedDrug-refractory Paroxysmal Atrial FibrillationSpain
-
Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
-
Biosense Webster, Inc.CompletedDrug Refractory Symptomatic Paroxysmal Atrial FibrillationUnited States
-
Medtronic Cardiac Rhythm and Heart FailureMedtronic Atrial Fibrillation SolutionsCompletedSymptomatic Paroxysmal Atrial Fibrillation Without Clinically Significant Heart DiseasesNetherlands, Australia, France, Norway, Germany, Croatia, Italy, Argentina, Belgium
-
Beijing Anzhen HospitalJohnson & Johnson; Heart Health Research CenterNot yet recruitingParoxysmal Atrial Fibrillation | Persistent Atrial Fibrillation
Clinical Trials on Pulmonary Vein Isolation alone
-
University of LeipzigRecruiting
-
University of PennsylvaniaWithdrawnTypical Atrial Flutter | Risk Factors With Future Development of Atrial FlutterUnited States
-
University Medical Center GroningenBoston Scientific CorporationNot yet recruiting
-
Instituto de investigación e innovación biomédica...Active, not recruitingAtrial Fibrillation, PersistentSpain
-
ElsanRecruitingPersistent Atrial FibrillationFrance
-
Hospital General Universitario de AlicanteNot yet recruiting
-
AtriCure, Inc.Active, not recruitingAtrial FibrillationUnited States
-
Asklepios proresearchCompletedAtrial Fibrillation | TachycardiaGermany
-
Diagram B.V.CompletedParoxysmal Atrial Fibrillation | Persistent Atrial Fibrillation | Out of Range Hypertension | Signs of Sympathetic OverdriveSpain, Netherlands
-
Haukeland University HospitalUniversity Hospital of North Norway; St. Olavs HospitalCompletedPersistent Atrial FibrillationNorway