Zero Fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for Right Atrial Arrhythmias

NCT03151278 | Completed DMC

• 1 other identifier: TJHCDD-ZF-RAA-20110131
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach with conventional fluoroscopic approach as performing catheter ablation of right atrial arrhythmias.

Conditions

Atrial Arrhythmia; Atrial Premature Complexes; Atrial Tachycardia

Keywords

Fluoroscopy; Ablation; Three dimensional; Atrial arrhythmia; Radiation

Outcome Measures

Primary Outcomes (1)

• Total success rates

  The patients have no related arrhythias or recurrence during follow up.

  3 months

Secondary Outcomes (5)

• Total procedure time

  during procedure

• Fluoroscopy time

  during procedure

• Complications

  6 months

• Immediate success rate

  24 hours

• Recurrence rate

  6 months

Study Arms (2)

Zero-fluoroscopy ablation

EXPERIMENTAL

Atrial arrhythmias will be mapped and ablated under the guidance of three-dimensional mapping system without fluoroscopy.

Procedure: Zero-fluoroscopy ablation

Conventional fluoroscopy ablation

ACTIVE COMPARATOR

Atrial arrhythmias will be mapped and ablated under fluoroscopic guidance plus three-dimensional mapping system.

Procedure: Conventional fluoroscopy ablation

Interventions

Zero-fluoroscopy ablation PROCEDURE

Catheter ablation will be performed under the guidance of one kind of three-dimensional navigation system and without fluoroscopic guidance.

Zero-fluoroscopy ablation

Conventional fluoroscopy ablation PROCEDURE

Catheter ablation will be performed using fluoroscopy plus one kind of three-dimensional navigation system.

Conventional fluoroscopy ablation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Atrial Tachycardia
• Atrial Premature Complexes

You may not qualify if:

• Left Atrial Premature Complexes
• Left Atrial Tachycardia

Sponsors & Collaborators

• Tongji Hospital: lead
• Fu Wai Hospital, Beijing, China: collaborator
• Xinyang Central Hospital: collaborator
• Ningbo No. 1 Hospital: collaborator
• Shanghai Tongji Hospital, Tongji University School of Medicine: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• Shenzhen Sun Yat-sen Cardiovascular Hospital: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Zhongshan Hospital Xiamen University: collaborator

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

Related Publications (5)

• Gelsomino S, La Meir M, Luca F, Lorusso R, Crudeli E, Vasquez L, Gensini GF, Maessen J. Treatment of lone atrial fibrillation: a look at the past, a view of the present and a glance at the future. Eur J Cardiothorac Surg. 2012 Jun;41(6):1284-94. doi: 10.1093/ejcts/ezr222. Epub 2012 Jan 10.

  PMID: 22233800 BACKGROUND

• Birnie D, Healey JS, Krahn AD, Ahmad K, Crystal E, Khaykin Y, Chauhan V, Philippon F, Exner D, Thibault B, Hruczkowski T, Nery P, Keren A, Redfearn D. Prevalence and risk factors for cervical and lumbar spondylosis in interventional electrophysiologists. J Cardiovasc Electrophysiol. 2011 Sep;22(9):957-60. doi: 10.1111/j.1540-8167.2011.02041.x. Epub 2011 Mar 8.

  PMID: 21385267 BACKGROUND

• Sra J, Krum D, Hare J, Okerlund D, Thompson H, Vass M, Schweitzer J, Olson E, Foley WD, Akhtar M. Feasibility and validation of registration of three-dimensional left atrial models derived from computed tomography with a noncontact cardiac mapping system. Heart Rhythm. 2005 Jan;2(1):55-63. doi: 10.1016/j.hrthm.2004.10.035.

  PMID: 15851266 BACKGROUND

• Oral H, Crawford T, Frederick M, Gadeela N, Wimmer A, Dey S, Sarrazin JF, Kuhne M, Chalfoun N, Wells D, Good E, Jongnarangsin K, Chugh A, Bogun F, Pelosi F Jr, Morady F. Inducibility of paroxysmal atrial fibrillation by isoproterenol and its relation to the mode of onset of atrial fibrillation. J Cardiovasc Electrophysiol. 2008 May;19(5):466-70. doi: 10.1111/j.1540-8167.2007.01089.x. Epub 2008 Feb 4.

  PMID: 18266669 BACKGROUND

• Razminia M, Manankil MF, Eryazici PL, Arrieta-Garcia C, Wang T, D'Silva OJ, Lopez CS, Crystal GJ, Khan S, Stancu MM, Turner M, Anthony J, Zheutlin TA, Kehoe RF. Nonfluoroscopic catheter ablation of cardiac arrhythmias in adults: feasibility, safety, and efficacy. J Cardiovasc Electrophysiol. 2012 Oct;23(10):1078-86. doi: 10.1111/j.1540-8167.2012.02344.x. Epub 2012 May 9.

  PMID: 22571735 BACKGROUND

MeSH Terms

Conditions

Atrial Premature Complexes

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yan Wang, PhD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 12, 2017
• Study Start: January 1, 2011
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)