Addition of Six Short Lines on Pulmonary Vein Isolation

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

Addition of Six Short Ablation Lines on Pulmonary Vein Isolation Circumferences Reduces Recurrence Rate of Paroxysmal Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02637453
• Other study ID #: ShanghaiXinhua-Af
• Status: Completed
• Phase: N/A
• Start date: January 4, 2017
• Est. completion date: January 10, 2021

Study information

• Verified date: April 2021
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We randomly assigned 390 patients with symptomatic, paroxysmal AF to undergo catheter ablation with PVI (PVI group) alone or combined with 6 additional ablation lines extended outside the PVI circumferences at 1, 3 and 6 o'clock of left PV and 6, 9 and 11 o'clock of right PV (PVI+6L group). Patients received monthly 12-lead electrocardiogram, 24-hour Holter at 3, 6 and 9 months and 14-days continuous monitoring at 12 months to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was freedom from AF recurrence between 91 and 365 days after catheter ablation. The secondary end points included the AF burden, procedural parameters, and complications.

Description:

We randomly assigned 390 patients with symptomatic, paroxysmal AF to undergo catheter ablation with PVI (PVI group) alone or combined with 6 additional ablation lines extended outside the PVI circumferences at 1, 3 and 6 o'clock of left PV and 6, 9 and 11 o'clock of right PV (PVI+6L group). Patients received monthly 12-lead electrocardiogram, 24-hour Holter at 3, 6 and 9 months and 14-days continuous monitoring at 12 months to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was freedom from AF recurrence between 91 and 365 days after catheter ablation. The secondary end points included the AF burden, procedural parameters, and complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: January 10, 2021
• Est. primary completion date: January 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion criteria

1. Patients between the ages of 18 and 80 years undergoing their first ablation of atrial fibrillation.

2. Diagnosed with symptomatic paroxysmal atrial fibrillation, defined as an documented episode of atrial fibrillation that lasts more than 30 seconds and terminates in less than 7 days.

3. Resistant or intolerant to at least one class I, II, or III antiarrhythmic drugs.

4. Patients deemed candidates for radiofrequency ablation of atrial fibrillation.

5. Able and willing to comply with pre-, post-, and follow-up requirements.

Exclusion criteria

1. Left atrial thrombus by pre-procedural imaging.

2. Uncontrolled heart failure: New York Heart Association Class III or IV, or left ventricular ejection fraction< 40%

3. Myocardial infarction, unstable angina, coronary stenting within the previous 90 days.

4. Stroke or any thrombo-embolic events within the previous 90 days.

5. Expecting cardiac transplantation or other cardiac surgery within 180 days.

6. History of catheter ablation of atrial fibrillation, atrial flutter or atrial tachycardia.

7. History of blood clotting or bleeding abnormalities.

8. Contraindication to anticoagulation.

9. History of cardiac surgery.

10. Uncontrolled maligment tumor.

11. Patients in dialysis or creatinine > 221 µmol/L.

12. Patients with alanine aminotransferase > 150 U/L or aspartate aminotransferase > 76 U/L

13. Acute illness or active infection at time of index procedure or leukocytosis for which antibiotics have been or will be prescribed.

14. Life expectancy less than 1 year.

15. Women who are pregnant or who plan to become pregnant during the study.

16. Other significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Procedure:
• PVI
Pulmonary vein isolation
• CPVI+6L
After PVI, 6 ablation lines were added with an extension from pulmonary vein ostium at 1, 3 and 6 o'clock (from internal view) of left PV and 6, 9 and 11 o'clock of right PV

Locations

Country	Name	City	State
China	Xinhua Hospital, Shanghai Jiao Tong University School of Medicne	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai Chest Hospital, Shanghai East Hospital, Xuzhou Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (12)

Calò L, Rebecchi M, Sciarra L, De Luca L, Fagagnini A, Zuccaro LM, Pitrone P, Dottori S, Porfirio M, de Ruvo E, Lioy E. Catheter ablation of right atrial ganglionated plexi in patients with vagal paroxysmal atrial fibrillation. Circ Arrhythm Electrophysiol. 2012 Feb;5(1):22-31. doi: 10.1161/CIRCEP.111.964262. Epub 2011 Dec 6. — View Citation

Cheema A, Vasamreddy CR, Dalal D, Marine JE, Dong J, Henrikson CA, Spragg D, Cheng A, Nazarian S, Sinha S, Halperin H, Berger R, Calkins H. Long-term single procedure efficacy of catheter ablation of atrial fibrillation. J Interv Card Electrophysiol. 2006 Apr;15(3):145-55. Epub 2006 Aug 5. — View Citation

Haïssaguerre M, Jaïs P, Shah DC, Takahashi A, Hocini M, Quiniou G, Garrigue S, Le Mouroux A, Le Métayer P, Clémenty J. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med. 1998 Sep 3;339(10):659-66. — View Citation

Katritsis 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. — View Citation

Noheria A, Kumar A, Wylie JV Jr, Josephson ME. Catheter ablation vs antiarrhythmic drug therapy for atrial fibrillation: a systematic review. Arch Intern Med. 2008 Mar 24;168(6):581-6. doi: 10.1001/archinte.168.6.581. Review. — View Citation

Ouyang F, Tilz R, Chun J, Schmidt B, Wissner E, Zerm T, Neven K, Köktürk B, Konstantinidou M, Metzner A, Fuernkranz A, Kuck KH. Long-term results of catheter ablation in paroxysmal atrial fibrillation: lessons from a 5-year follow-up. Circulation. 2010 Dec 7;122(23):2368-77. doi: 10.1161/CIRCULATIONAHA.110.946806. Epub 2010 Nov 22. — View Citation

Reddy VY, Dukkipati SR, Neuzil P, Natale A, Albenque JP, Kautzner J, Shah D, Michaud G, Wharton M, Harari D, Mahapatra S, Lambert H, Mansour M. Randomized, Controlled Trial of the Safety and Effectiveness of a Contact Force-Sensing Irrigated Catheter for Ablation of Paroxysmal Atrial Fibrillation: Results of the TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR) Study. Circulation. 2015 Sep 8;132(10):907-15. doi: 10.1161/CIRCULATIONAHA.114.014092. Epub 2015 Aug 10. — View Citation

Stabile G, Bertaglia E, Senatore G, De Simone A, Zoppo F, Donnici G, Turco P, Pascotto P, Fazzari M, Vitale DF. Catheter ablation treatment in patients with drug-refractory atrial fibrillation: a prospective, multi-centre, randomized, controlled study (Catheter Ablation For The Cure Of Atrial Fibrillation Study). Eur Heart J. 2006 Jan;27(2):216-21. Epub 2005 Oct 7. — View Citation

Steinberg BA, Beckley PD, Deering TF, Clark CL, Amin AN, Bauer KA, Cryer B, Mansour M, Scheiman JM, Zenati MA, Newby LK, Peacock WF, Bhatt DL; Society of Cardiovascular Patient Care. Evaluation and management of the atrial fibrillation patient: a report from the Society of Cardiovascular Patient Care. Crit Pathw Cardiol. 2013 Sep;12(3):107-15. doi: 10.1097/HPC.0b013e31829834ed. — View Citation

Weerasooriya R, Khairy P, Litalien J, Macle L, Hocini M, Sacher F, Lellouche N, Knecht S, Wright M, Nault I, Miyazaki S, Scavee C, Clementy J, Haissaguerre M, Jais P. Catheter ablation for atrial fibrillation: are results maintained at 5 years of follow-up? J Am Coll Cardiol. 2011 Jan 11;57(2):160-6. doi: 10.1016/j.jacc.2010.05.061. — View Citation

Wilber DJ, Pappone C, Neuzil P, De Paola A, Marchlinski F, Natale A, Macle L, Daoud EG, Calkins H, Hall B, Reddy V, Augello G, Reynolds MR, Vinekar C, Liu CY, Berry SM, Berry DA; ThermoCool AF Trial Investigators. Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial. JAMA. 2010 Jan 27;303(4):333-40. doi: 10.1001/jama.2009.2029. — View Citation

Zhang S. Atrial fibrillation in mainland China: epidemiology and current management. Heart. 2009 Jul;95(13):1052-5. doi: 10.1136/hrt.2008.146589. Epub 2009 Mar 23. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from AF recurrence between 91 and 365 days	AF recurrence was defined by AF (including atrial flutter or atrial tachycardia) of 30 seconds or more captured by ECG monitoring or any clinical presentation with AF outside the 90-day blanking period (between 91 and 365 days). Cardioversion, or use of class I or III antiarrhythmic drugs outside blanking period was also considered as AF recurrence.	91 to 365 days
Secondary	AF burden	Percentage of time in AF, atrial flutter or atrial tachycardia on 14-days continuous monitoring at 12 months.	12 months
Secondary	Procedural time	Total procedural time from femoral vein puncture to decannulation (skin-to-skin time)	Within procedure
Secondary	Fluoroscopy time	Time of patients' exposure to the real-time X-ray imaging during the procedure.	Within procedure
Secondary	Ablation time	Radiofrequency delivery time during the procedure.	Within procedure
Secondary	Early onset complications	Complications within 30 days post-ablation, including death, myocardial infarction, diaphragmatic paralysis, stroke or transient ischemic attack, systemic embolism, pericardial effusion or tamponade requiring drainage, heart block, pericarditis, and vascular access complications requiring intervention.	Within 30 days
Secondary	Late onset complications	Complications detected any time during the follow-up, including severe pulmonary vein stenosis (>70%), and atrioesophageal fistula.	within 12 months