Assessment of Reconstruction and Inverse Reconstruction in Right Atrium by Multimodal Echocardiographic Techniques

NCT02838914 | Unknown DMC

• 1 other identifier: XH-16-006
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the reconstruction and inverse reconstruction in right atrium by speckle tracking echocardiography combined with real-time three dimensional echocardiography for atrial fibrillation patients before and after radiofrequency ablation (RFCA)

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Right atrium; Echocardiography; Remodeling

Outcome Measures

Primary Outcomes (1)

• Remodeling in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients

  In one week before RFCA

Secondary Outcomes (4)

• Remodeling in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients

  In one week after RFCA

• Inverse reconstruction in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients

  At three months after RFCA

• Inverse reconstruction in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients

  At six months after RFCA

• Adverse event that is related to RFCA, such as the incidence of cardiac tamponade (%) was obtained by echocardiography

  In one week after RFCA

Other Outcomes (1)

• Adverse events that are related to RFCA, such as the incidence of pulmonary vein stenosis(%) and embolism(%) were obtained by CT

  At six months after RFCA

Study Arms (2)

patients with AF

EXPERIMENTAL

Before radiofrequency ablation (RFCA)

Procedure: radiofrequency ablation (RFCA)

Assigned Comparisons

EXPERIMENTAL

After radiofrequency ablation (RFCA)

Procedure: radiofrequency ablation (RFCA)

Interventions

radiofrequency ablation (RFCA) PROCEDURE

Patients undergo radiofrequency ablation (RFCA)

Assigned Comparisons; patients with AF

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• With a history of paroxysmal Af (PAF) and PAF record within 6 months prior to ablation, confirming at least one of the following findings: AF lasting for ≥30 s recorded in Holter or 12-lead ECG.
• No response to more than one antiarrhythmic drug, or unwilling to receive longterm drug treatment.
• Can provide informed consent form expressing willingness to participate in the study and comply with follow-up tests and evaluation procedures.
• Aged 18-80 years.

You may not qualify if:

• With acute diseases, such as acute phase after myocardial infarction (within 3 months), within 3 months after acute heart failure or new cerebral infarction;
• In the list of heart transplantation;
• Expected survival less than 1 year;
• With other hemorrhagic diseases and anticoagulant therapy is not allowed;
• Thrombosis in left atrium;
• Heart failure, New York Heart Association(NYHA) III/IV or eject fraction(EF)\<40%;
• Patients with uncontrolled cancer;
• Significant hepatic or renal impairment (and/or alanine transaminase(ALT) or Aspartate transaminase(AST) \>2 times upper limit of normal, creatinine clearance rate(CCr)\<50%);
• Previous catheter radiofrequency ablation for AF or cardiac surgery;
• Pregnant and lactating women, women who plan to become pregnant, or women of child bearing age not using reliable contraceptive measures.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital,Shanghai Jiao Tong University School of Medicine

Shanghai, 200092, China

RECRUITING

Related Publications (14)

• Thihalolipavan S, Morin DP. Atrial fibrillation and congestive heart failure. Heart Fail Clin. 2014 Apr;10(2):305-18. doi: 10.1016/j.hfc.2013.12.005. Epub 2014 Feb 4.

  PMID: 24656107 RESULT

• Extramiana F, Maison-Blanche P. Stroke and atrial fibrillation: where to go from here? Stroke. 2015 Mar;46(3):605-7. doi: 10.1161/STROKEAHA.114.007809. Epub 2015 Jan 29. No abstract available.

  PMID: 25634002 RESULT

• January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available.

  PMID: 24685669 RESULT

• Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH; ESC Committee for Practice Guidelines. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Europace. 2010 Oct;12(10):1360-420. doi: 10.1093/europace/euq350. No abstract available.

  PMID: 20876603 RESULT

• Rondano E, Dell'Era G, De Luca G, Piccinino C, Bellomo G, Marino PN. Left atrial asynchrony is a major predictor of 1-year recurrence of atrial fibrillation after electrical cardioversion. J Cardiovasc Med (Hagerstown). 2010 Jul;11(7):499-506. doi: 10.2459/JCM.0b013e32833757b5.

  PMID: 20445461 RESULT

• Wang Z, Tan H, Zhong M, Jiang G, Zhang Y, Zhang W. Strain rate imaging for noninvasive functional quantification of the left atrium in hypertensive patients with paroxysmal atrial fibrillation. Cardiology. 2008;109(1):15-24. doi: 10.1159/000105322. Epub 2007 Jul 10.

  PMID: 17627105 RESULT

• Lee YS, Hyun DW, Jung BC, Cho YK, Lee SH, Shin DG, Park HS, Han SW, Kim YN; KTK Cardiac Electrophysiology Working Group. Left atrial volume index as a predictor for occurrence of atrial fibrillation after ablation of typical atrial flutter. J Cardiol. 2010 Nov;56(3):348-53. doi: 10.1016/j.jjcc.2010.07.006.

  PMID: 20889311 RESULT

• Muller H, Reverdin S, Burri H, Shah D, Lerch R. Measurement of left and right atrial volume in patients undergoing ablation for atrial arrhythmias: comparison of a manual versus semiautomatic algorithm of real time 3D echocardiography. Echocardiography. 2014 Apr;31(4):499-507. doi: 10.1111/echo.12391. Epub 2013 Oct 15.

  PMID: 24128369 RESULT

• Peluso D, Badano LP, Muraru D, Dal Bianco L, Cucchini U, Kocabay G, Kovacs A, Casablanca S, Iliceto S. Right atrial size and function assessed with three-dimensional and speckle-tracking echocardiography in 200 healthy volunteers. Eur Heart J Cardiovasc Imaging. 2013 Nov;14(11):1106-14. doi: 10.1093/ehjci/jet024. Epub 2013 Feb 19.

  PMID: 23423966 RESULT

• Marwick TH, Leano RL, Brown J, Sun JP, Hoffmann R, Lysyansky P, Becker M, Thomas JD. Myocardial strain measurement with 2-dimensional speckle-tracking echocardiography: definition of normal range. JACC Cardiovasc Imaging. 2009 Jan;2(1):80-4. doi: 10.1016/j.jcmg.2007.12.007.

  PMID: 19356538 RESULT

• Reant P, Labrousse L, Lafitte S, Bordachar P, Pillois X, Tariosse L, Bonoron-Adele S, Padois P, Deville C, Roudaut R, Dos Santos P. Experimental validation of circumferential, longitudinal, and radial 2-dimensional strain during dobutamine stress echocardiography in ischemic conditions. J Am Coll Cardiol. 2008 Jan 15;51(2):149-57. doi: 10.1016/j.jacc.2007.07.088.

  PMID: 18191740 RESULT

• Mor-Avi V, Lang RM, Badano LP, Belohlavek M, Cardim NM, Derumeaux G, Galderisi M, Marwick T, Nagueh SF, Sengupta PP, Sicari R, Smiseth OA, Smulevitz B, Takeuchi M, Thomas JD, Vannan M, Voigt JU, Zamorano JL. Current and evolving echocardiographic techniques for the quantitative evaluation of cardiac mechanics: ASE/EAE consensus statement on methodology and indications endorsed by the Japanese Society of Echocardiography. Eur J Echocardiogr. 2011 Mar;12(3):167-205. doi: 10.1093/ejechocard/jer021.

  PMID: 21385887 RESULT

• Mirza M, Caracciolo G, Khan U, Mori N, Saha SK, Srivathsan K, Altemose G, Scott L, Sengupta P, Jahangir A. Left atrial reservoir function predicts atrial fibrillation recurrence after catheter ablation: a two-dimensional speckle strain study. J Interv Card Electrophysiol. 2011 Sep;31(3):197-206. doi: 10.1007/s10840-011-9560-6. Epub 2011 Mar 22.

  PMID: 21424845 RESULT

• Puwanant S, Park M, Popovic ZB, Tang WH, Farha S, George D, Sharp J, Puntawangkoon J, Loyd JE, Erzurum SC, Thomas JD. Ventricular geometry, strain, and rotational mechanics in pulmonary hypertension. Circulation. 2010 Jan 19;121(2):259-66. doi: 10.1161/CIRCULATIONAHA.108.844340. Epub 2010 Jan 4.

  PMID: 20048214 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Kun Sun, M.D.;Ph.D.

  Department of Ultrasound, Xinhua Hospital, Shanghai Jiaotong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun Sun, M.D.;Ph.D.

CONTACT

13651696395; sunkunxh@163.com

Yi Yu, M.D.

CONTACT

13817308128; yuyi20122012@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice professor

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: July 20, 2016
• Study Start: June 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: August 1, 2019
• Last Updated: December 19, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)