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

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

Assessment of Reconstruction and Inverse Reconstruction in Right Atrium by by Multimodal Echocardiographic Techniques for Atrial Fibrillation Patients Before and After Radiofrequency Ablation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02838914
• Other study ID #: XH-16-006
• Status: Recruiting
• Phase: N/A
• Start date: June 2015
• Est. completion date: August 2019

Study information

• Verified date: December 2018
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Kun Sun, M.D.;Ph.D.
• Phone: 13651696395
• Email: sunkunxh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

The prevalence of atrial fibrillation (AF) has increased in recent years. The construction and function of right atrium haven't shown clearly before and after radiofrequency ablation (RFCA).The purpose of the study is to investigate whether RFCA can lead to inverse reconstruction of right atrium for atrial fibrillation patients, which diagnosing by speckle tracking echocardiography combined with real-time three dimensional echocardiography. All patients will be followed up for 12 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 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.

2. No response to more than one antiarrhythmic drug, or unwilling to receive longterm drug treatment.

3. Can provide informed consent form expressing willingness to participate in the study and comply with follow-up tests and evaluation procedures.

4. Aged 18-80 years.

Exclusion Criteria:

1. With acute diseases, such as acute phase after myocardial infarction (within 3 months), within 3 months after acute heart failure or new cerebral infarction;

2. In the list of heart transplantation;

3. Expected survival less than 1 year;

4. With other hemorrhagic diseases and anticoagulant therapy is not allowed;

5. Thrombosis in left atrium;

6. Heart failure, New York Heart Association(NYHA) III/IV or eject fraction(EF)<40%;

7. Patients with uncontrolled cancer;

8. 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%);

9. Previous catheter radiofrequency ablation for AF or cardiac surgery;

10. Pregnant and lactating women, women who plan to become pregnant, or women of child bearing age not using reliable contraceptive measures.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Procedure:
• radiofrequency ablation (RFCA)
Patients undergo radiofrequency ablation (RFCA)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (14)

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, L — View Citation

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. — View Citation

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 — View Citation

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. 201 — View Citation

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/ — View Citation

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 Car — View Citation

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 techniqu — View Citation

Müller 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. 2 — View Citation

Peluso D, Badano LP, Muraru D, Dal Bianco L, Cucchini U, Kocabay G, Kovàcs 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 I — View Citation

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/CI — View Citation

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 echocard — View Citation

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: 10.245 — View Citation

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. Review. — View Citation

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. Epub 2007 Jul 10. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Remodeling in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients		In one week after RFCA
Secondary	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
Secondary	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
Secondary	Adverse event that is related to RFCA, such as the incidence of cardiac tamponade (%) was obtained by echocardiography		In one week after RFCA