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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

214

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

Study Start

First participant enrolled

August 1, 2016

Completed

26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2016

Completed

12 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed

Last Updated

September 20, 2016

Status Verified

September 1, 2016

Enrollment Period

11 months

First QC Date

August 27, 2016

Last Update Submit

September 18, 2016

Conditions

Persistent Atrial Fibrillation

Keywords

atrial fibrillationcatheter ablation

Outcome Measures

Primary Outcomes (1)

AF recurrence
Freedom from AF at 1 year without any anti-arrhythmic drugs. Recurrent AF is defined as documented AF (through 12-lead ECG or Holter) period lasting \>30 seconds after a 3-month blanking period.
From August, 2016 to July 2019. The overall Time Frame for AF recurrence is being assessed up to 36 months.

Secondary Outcomes (4)

Acute success rate of AF termination during ablation procedure
From August, 2016 to July 2017. The overall Time Frame for AF termination during ablation procedure is being assessed up to 12 months.
Frequency of complications
From August, 2016 to July 2017. The overall Time Frame for frequency of complications is being assessed up to 12 months.
Average radiation exposure
From August, 2016 to July 2017. The overall Time Frame for average radiation exposure is being assessed up to 12 months.
Frequency of redo procedures
From August, 2016 to July 2019. The overall Time Frame for frequency of redo procedures is being assessed up to 12 months.

Other Outcomes (1)

Average ablation time and procedure time
From August, 2016 to July 2017. The overall Time Frame for average ablation time and procedure time are being assessed up to 12 months.

Study Arms (2)

With additional LAAW linear ablation

EXPERIMENTAL

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

Procedure: Additional LAAW linear ablation

Without additional LAAW linear ablation

ACTIVE COMPARATOR

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

Procedure: Additional LAAW linear ablation

Interventions

Additional LAAW linear ablationPROCEDURE

Additional linear ablation on LAAW using ThermoCool SmartTouch ablation catheter.

With additional LAAW linear ablationWithout additional LAAW linear ablation

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

Patients without spontaneous ongoing AF at the beginning of the procedure;
Age: \<18 years or \>70 years;
LA size \> 55mm measured on echocardiogram;
Previous AF ablation history including surgical ablation;
Documented LA thrombus;
Severe pulmonary diseases;
Previous cardiac surgical history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

China National Center for Cardiovascular Diseaseslead
Beijing Hospitalcollaborator
First Affiliated Hospital, Sun Yat-Sen Universitycollaborator
Tianjin Medical University General Hospitalcollaborator
Wuhan Asia Heart Hospitalcollaborator
First Affiliated Hospital of Kunming Medical Universitycollaborator

Study Sites (1)

China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

RECRUITING

Related Publications (7)

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.
PMID: 24682348BACKGROUND
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.
PMID: 22922413BACKGROUND
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.
PMID: 22550126BACKGROUND
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.
PMID: 23062545BACKGROUND
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.
PMID: 22245414BACKGROUND
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.
PMID: 17997359BACKGROUND
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.
PMID: 24400694BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Yan Yao, MD,PhD
China National Center for Cardiovascular Diseases
PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Yao, MD,PhD

CONTACT

+86-13901121319 ianyao@263.net.cn

Lingmin Wu, MD,PhD

CONTACT

+86-18810488351 wlmxt2008@126.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER GOV
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

August 27, 2016

First Posted

September 8, 2016

Study Start

August 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2019

Last Updated

September 20, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing: Will not share

Locations

CN(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (1)

Study Arms (2)

With additional LAAW linear ablation

Without additional LAAW linear ablation

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (7)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations