Inhibition of Atrial Fibrillation by Elimination of Transitional Mechanisms

NCT02758002 | Withdrawn

• 1 other identifier: 151850
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

There is growing awareness of the importance of electrical rotors to the maintenance of atrial fibrillation (AF). Recent work in our laboratory has found that AF evolves over time, from rapid, focal activation, next to transitional rotors, and finally to stable, long duration rotors, whose locations are frequently separate from the transitional rotor sites. This project will test the hypothesis that mapping and ablation of the transitional rotors sites may prevent atrial fibrillation from progressing to sustained atrial fibrillation, and therefore increase the AF initiation threshold. The investigators will test this hypothesis during clinically-indicated electrophysiology study prior to ablation of symptomatic AF.

Conditions

Atrial Fibrillation; Arrhythmia

Keywords

atrial fibrillation ablation; ablation; atrial fibrillation rotors

Outcome Measures

Primary Outcomes (1)

• Changes in AF threshold induction from ablation of transitional rotors

  In patients presenting for AF ablation, the investigator will prospectively determine whether ablation of AF-initiating sites renders AF more difficult to induce, as measured by the rapid pacing cycle length required to initiate AF during two induction attempts consisting of rapid pacing of 15 seconds duration at decreasing cycle lengths.

  1 day

Study Arms (1)

Firm ablation for transitional AF rotors

EXPERIMENTAL

All subjects will undergo this ablation, in addition to their standard PVI and Firm ablation for sustained AF rotors.

Procedure: Firm ablation for transitional AF rotors

Interventions

Firm ablation for transitional AF rotors PROCEDURE

Transitional AF rotors will be mapped and ablated as part of this study. All subjects will undergo this ablation after standard PVI and Firm ablation for sustained rotors.

Firm ablation for transitional AF rotors

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with symptomatic atrial fibrillation (AF) undergoing clinically-indicated ablation
• either persistent or paroxysmal AF

You may not qualify if:

• decompensated heart failure;
• non-revascularized coronary ischemia
• LA diameter \> 60mm
• inability or refusal to provide consent

Sponsors & Collaborators

• University of California, San Diego: lead
• Abbott: collaborator

Study Sites (1)

Sulpizio Cardiovascular Center

La Jolla, California, 92037, United States

Location

Related Publications (18)

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  PMID: 25217042 BACKGROUND

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• Wilber DJ, Pappone C, Neuzil P, De Paola A, Marchlinski F, Natale A, Macle L, Daoud EG, Calkins H, Hall B, Reddy V, Augello G, Reynolds MR, Vinekar C, Liu CY, Berry SM, Berry DA; ThermoCool AF Trial Investigators. Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial. JAMA. 2010 Jan 27;303(4):333-40. doi: 10.1001/jama.2009.2029.

  PMID: 20103757 BACKGROUND

• Narayan SM, Baykaner T, Clopton P, Schricker A, Lalani GG, Krummen DE, Shivkumar K, Miller JM. Ablation of rotor and focal sources reduces late recurrence of atrial fibrillation compared with trigger ablation alone: extended follow-up of the CONFIRM trial (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation). J Am Coll Cardiol. 2014 May 6;63(17):1761-8. doi: 10.1016/j.jacc.2014.02.543. Epub 2014 Mar 13.

  PMID: 24632280 BACKGROUND

• Miller JM, Kowal RC, Swarup V, Daubert JP, Daoud EG, Day JD, Ellenbogen KA, Hummel JD, Baykaner T, Krummen DE, Narayan SM, Reddy VY, Shivkumar K, Steinberg JS, Wheelan KR. Initial independent outcomes from focal impulse and rotor modulation ablation for atrial fibrillation: multicenter FIRM registry. J Cardiovasc Electrophysiol. 2014 Sep;25(9):921-929. doi: 10.1111/jce.12474. Epub 2014 Jul 23.

  PMID: 24948520 BACKGROUND

• Narayan SM, Krummen DE, Rappel WJ. Clinical mapping approach to diagnose electrical rotors and focal impulse sources for human atrial fibrillation. J Cardiovasc Electrophysiol. 2012 May;23(5):447-54. doi: 10.1111/j.1540-8167.2012.02332.x. Epub 2012 Apr 26.

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  PMID: 10545432 BACKGROUND

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  PMID: 16510747 BACKGROUND

• Cosedis Nielsen J, Johannessen A, Raatikainen P, Hindricks G, Walfridsson H, Kongstad O, Pehrson S, Englund A, Hartikainen J, Mortensen LS, Hansen PS. Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation. N Engl J Med. 2012 Oct 25;367(17):1587-95. doi: 10.1056/NEJMoa1113566.

  PMID: 23094720 BACKGROUND

• Miyasaka Y, Barnes ME, Gersh BJ, Cha SS, Bailey KR, Abhayaratna WP, Seward JB, Tsang TS. Secular trends in incidence of atrial fibrillation in Olmsted County, Minnesota, 1980 to 2000, and implications on the projections for future prevalence. Circulation. 2006 Jul 11;114(2):119-25. doi: 10.1161/CIRCULATIONAHA.105.595140. Epub 2006 Jul 3.

  PMID: 16818816 BACKGROUND

• Sommer P, Kircher S, Rolf S, John S, Arya A, Dinov B, Richter S, Bollmann A, Hindricks G. Successful Repeat Catheter Ablation of Recurrent Longstanding Persistent Atrial Fibrillation With Rotor Elimination as the Procedural Endpoint: A Case Series. J Cardiovasc Electrophysiol. 2016 Mar;27(3):274-80. doi: 10.1111/jce.12874. Epub 2015 Dec 21.

  PMID: 26527103 BACKGROUND

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  PMID: 24026969 BACKGROUND

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  PMID: 24061087 BACKGROUND

• Narayan SM, Krummen DE, Shivkumar K, Clopton P, Rappel WJ, Miller JM. Treatment of atrial fibrillation by the ablation of localized sources: CONFIRM (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation) trial. J Am Coll Cardiol. 2012 Aug 14;60(7):628-36. doi: 10.1016/j.jacc.2012.05.022. Epub 2012 Jul 18.

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MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

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

Study Officials

• Amir Schricker, MD, MS

  UCSD School of Medicine / San Diego Veteran's Affairs Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 2, 2016
• Study Start: January 28, 2016
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)