Catheter Ablation Therapy for Persistent Atrial Fibrillation

NCT ID: NCT02892162

Last Updated: 2016-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-07-31

Brief Summary

Use of catheter ablation for persistent atrial fibrillation (PerAF) remains controversial due to unsatisfactory long-term success rates (15% - 28.4%). The investigators' previous study indicated that the upper area of the left atrium (LA) plays an important role in PerAF, with the LA roof and mitral isthmus appearing to serve as main substrate in progression from PAF to PerAF and maintenance of fibrillatory activities. The investigators therefore hypothesized that AF should not be initiated or sustained if the latter crucial regions for AF maintenance are abolished. This study aimed to describe the efficacy and safety of additional linear ablation on the left atrial anterior wall for PerAF.

Detailed Description

Although studies and guidelines have helped establish catheter ablation as preferred treatment for patients suffering from paroxysmal atrial fibrillation (PAF), use of catheter ablation for persistent atrial fibrillation (PerAF) remains controversial due to unsatisfactory long-term success rates (15% - 28.4%).

The investigators' study indicated that the upper area of the left atrium (LA) plays an important role in PerAF, with the LA roof and mitral isthmus appearing to serve as main substrate in progression from PAF to PerAF and maintenance of fibrillatory activities. The investigators therefore hypothesized that AF should not be initiated or sustained if the latter crucial regions for AF maintenance are abolished. This was confirmed using a stepwise pure linear ablation protocol, consisting of a line across the LA roof and extending along the anterior wall of pulmonary veins (PV) antrum to mitral valve annulus (MVA) without PV isolation; the approach appeared safe and effective with long-term (5.2 years) follow-up success rate of 40% for PerAF.

This study will evaluate efficacy and safety of circumferential pulmonary vein isolation (CPVI) + LA roof linear ablation + LA anterior wall (LAAW) linear ablation combined with high density mapping and contact force sensing techniques for perAF. This study is expected to provide a practical and guided catheter ablation strategy with maximized safety and efficacy through use of contact force sensing technique, which will be accepted by other qualified electrophysiology laboratories.

Conditions

Persistent Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

With additional LAAW linear ablation

Patients who undergo CPVI+LA roof linear ablation+/ MI linear ablation, and additional LAAW linear ablation using ThermoCool SmartTouch catheter.

Group Type: EXPERIMENTAL

Additional LAAW linear ablation

Intervention Type: PROCEDURE

Additional linear ablation on LAAW using ThermoCool SmartTouch ablation catheter.

Without additional LAAW linear ablation

Patients who undergo CPVI+LA roof +/ MI linear ablation using ThermoCool SmartTouch catheter, without LAAW linear ablation.

Group Type: ACTIVE_COMPARATOR

Additional LAAW linear ablation

Intervention Type: PROCEDURE

Additional linear ablation on LAAW using ThermoCool SmartTouch ablation catheter.

Interventions

Additional LAAW linear ablation

Additional linear ablation on LAAW using ThermoCool SmartTouch ablation catheter.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• The main inclusion criterion is patients suffering from drug refractory persistent atrial fibrillation and referred to catheter ablation therapy. Persistent AF is defined as continuous AF for over 7 days, or lasting no more than 7 days but requiring pharmacological or electrical cardioversion.

Exclusion Criteria

1. Patients without spontaneous ongoing AF at the beginning of the procedure;

2. Age: <18 years or >70 years;

3. LA size > 55mm measured on echocardiogram;

4. Previous AF ablation history including surgical ablation;

5. Documented LA thrombus;

6. Severe pulmonary diseases;

7. Previous cardiac surgical history.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Hospital

OTHER_GOV

Sponsor Role: collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role: collaborator

Wuhan Asia Heart Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role: collaborator

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yan Yao, MD,PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yan Yao, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

China National Center for Cardiovascular Diseases

Locations

China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yan Yao, MD,PhD

Role: CONTACT

ianyao@263.net.cn

+86-13901121319

Lingmin Wu, MD,PhD

Role: CONTACT

wlmxt2008@126.com

+86-18810488351

Facility Contacts

Yan Yao, MD, PhD

Role: primary

ianyao@263.net.cn

+86-13901121319

Lingmin Wu, MD, PhD

Role: backup

wlmxt2008@126.com

+86-18810488351

References

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; ACC/AHA Task Force Members. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014 Dec 2;130(23):2071-104. doi: 10.1161/CIR.0000000000000040. Epub 2014 Mar 28. No abstract available.

Reference Type: BACKGROUND

PMID: 24682348 (View on PubMed)

Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines (CPG). 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J. 2012 Nov;33(21):2719-47. doi: 10.1093/eurheartj/ehs253. Epub 2012 Aug 24. No abstract available.

Reference Type: BACKGROUND

PMID: 22922413 (View on PubMed)

Chao TF, Tsao HM, Lin YJ, Tsai CF, Lin WS, Chang SL, Lo LW, Hu YF, Tuan TC, Suenari K, Li CH, Hartono B, Chang HY, Ambrose K, Wu TJ, Chen SA. Clinical outcome of catheter ablation in patients with nonparoxysmal atrial fibrillation: results of 3-year follow-up. Circ Arrhythm Electrophysiol. 2012 Jun 1;5(3):514-20. doi: 10.1161/CIRCEP.111.968032. Epub 2012 May 1.

Reference Type: BACKGROUND

PMID: 22550126 (View on PubMed)

Tilz RR, Rillig A, Thum AM, Arya A, Wohlmuth P, Metzner A, Mathew S, Yoshiga Y, Wissner E, Kuck KH, Ouyang F. Catheter ablation of long-standing persistent atrial fibrillation: 5-year outcomes of the Hamburg Sequential Ablation Strategy. J Am Coll Cardiol. 2012 Nov 6;60(19):1921-9. doi: 10.1016/j.jacc.2012.04.060. Epub 2012 Oct 10.

Reference Type: BACKGROUND

PMID: 23062545 (View on PubMed)

Sorgente A, Tung P, Wylie J, Josephson ME. Six year follow-up after catheter ablation of atrial fibrillation: a palliation more than a true cure. Am J Cardiol. 2012 Apr 15;109(8):1179-86. doi: 10.1016/j.amjcard.2011.11.058. Epub 2012 Jan 14.

Reference Type: BACKGROUND

PMID: 22245414 (View on PubMed)

Yao Y, Zheng L, Zhang S, He DS, Zhang K, Tang M, Chen K, Pu J, Wang F, Chen X. Stepwise linear approach to catheter ablation of atrial fibrillation. Heart Rhythm. 2007 Dec;4(12):1497-504. doi: 10.1016/j.hrthm.2007.07.028. Epub 2007 Aug 11.

Reference Type: BACKGROUND

PMID: 17997359 (View on PubMed)

Wu L, Yao Y, Zheng L, Zhang K, Zhang S. Long-term follow-up of pure linear ablation for persistent atrial fibrillation without circumferential pulmonary vein isolation. J Cardiovasc Electrophysiol. 2014 May;25(5):471-476. doi: 10.1111/jce.12360. Epub 2014 Jan 24.

Reference Type: BACKGROUND

PMID: 24400694 (View on PubMed)

Other Identifiers

2015-ZX51

Identifier Type: -

Identifier Source: org_study_id