Propagation ANalysis for Arrhythmogenic Conduction Elimination to Prevent Atrial Flutter and Fibrillation (PANACEA-AF)

NCT03737838 | Completed FDA Device

• 1 other identifier: IRB17-1769
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to perform ultra-high density mapping of the left atrium (a chamber of the heart) using the the Rhythmia Mapping System and to determine whether additional ablation in areas of wavefront discontinuities identified by the map will reduce the likelihood of both atrial fibrillation and atrial flutter.

Conditions

Atrial Fibrillation

Keywords

Paroxysmal; Atrial; Fibrillation; Ventricular; Tachycardia

Outcome Measures

Primary Outcomes (1)

• Freedom from recurrent atrial fibrillation and atrial flutter

  Freedom from atrial arrhythmias

  Baseline to 1 year

Interventions

Atrial fibrillation ablation DEVICE

High density mapping of left atrium using Rhythmia mapping system to identify gaps in conduction and wavefront discontinuities (deceleration zones)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prospective cohort of patients with AF refractory to prior ablation

You may qualify if:

• Patients at least 18 years of age
• Re-do AF ablation with history of PVI
• Undergone at least 1 prior ablation

You may not qualify if:

• Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity
• Recent stroke within 6 months of planned procedure
• Inability to take oral anticoagulation

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (9)

• Anter E, Tschabrunn CM, Buxton AE, Josephson ME. High-Resolution Mapping of Postinfarction Reentrant Ventricular Tachycardia: Electrophysiological Characterization of the Circuit. Circulation. 2016 Jul 26;134(4):314-27. doi: 10.1161/CIRCULATIONAHA.116.021955.

  PMID: 27440005 BACKGROUND

• Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.

  PMID: 25946280 BACKGROUND

• Irie T, Yu R, Bradfield JS, Vaseghi M, Buch EF, Ajijola O, Macias C, Fujimura O, Mandapati R, Boyle NG, Shivkumar K, Tung R. Relationship between sinus rhythm late activation zones and critical sites for scar-related ventricular tachycardia: systematic analysis of isochronal late activation mapping. Circ Arrhythm Electrophysiol. 2015 Apr;8(2):390-9. doi: 10.1161/CIRCEP.114.002637. Epub 2015 Mar 4.

  PMID: 25740836 BACKGROUND

• Anter E, McElderry TH, Contreras-Valdes FM, Li J, Tung P, Leshem E, Haffajee CI, Nakagawa H, Josephson ME. Evaluation of a novel high-resolution mapping technology for ablation of recurrent scar-related atrial tachycardias. Heart Rhythm. 2016 Oct;13(10):2048-55. doi: 10.1016/j.hrthm.2016.05.029. Epub 2016 Jun 1.

  PMID: 27262767 BACKGROUND

• Viswanathan K, Mantziari L, Butcher C, Hodkinson E, Lim E, Khan H, Panikker S, Haldar S, Jarman JW, Jones DG, Hussain W, Foran JP, Markides V, Wong T. Evaluation of a novel high-resolution mapping system for catheter ablation of ventricular arrhythmias. Heart Rhythm. 2017 Feb;14(2):176-183. doi: 10.1016/j.hrthm.2016.11.018. Epub 2016 Nov 17.

  PMID: 27867071 BACKGROUND

• Luther V, Sikkel M, Bennett N, Guerrero F, Leong K, Qureshi N, Ng FS, Hayat SA, Sohaib SM, Malcolme-Lawes L, Lim E, Wright I, Koa-Wing M, Lefroy DC, Linton NW, Whinnett Z, Kanagaratnam P, Davies DW, Peters NS, Lim PB. Visualizing Localized Reentry With Ultra-High Density Mapping in Iatrogenic Atrial Tachycardia: Beware Pseudo-Reentry. Circ Arrhythm Electrophysiol. 2017 Apr;10(4):e004724. doi: 10.1161/CIRCEP.116.004724.

  PMID: 28356307 BACKGROUND

• Ciaccio EJ, Chow AW, Davies DW, Wit AL, Peters NS. Localization of the isthmus in reentrant circuits by analysis of electrograms derived from clinical noncontact mapping during sinus rhythm and ventricular tachycardia. J Cardiovasc Electrophysiol. 2004 Jan;15(1):27-36. doi: 10.1046/j.1540-8167.2004.03134.x.

  PMID: 15028069 BACKGROUND

• Anter E, Tschabrunn CM, Contreras-Valdes FM, Li J, Josephson ME. Pulmonary vein isolation using the Rhythmia mapping system: Verification of intracardiac signals using the Orion mini-basket catheter. Heart Rhythm. 2015 Sep;12(9):1927-34. doi: 10.1016/j.hrthm.2015.05.019. Epub 2015 May 19.

  PMID: 26001505 BACKGROUND

• Wann LS, Curtis AB, January CT, Ellenbogen KA, Lowe JE, Estes NA 3rd, Page RL, Ezekowitz MD, Slotwiner DJ, Jackman WM, Stevenson WG, Tracy CM; 2011 Writing Group Members; Fuster V, Ryden LE, Cannom DS, Le Heuzey JY, Crijns HJ, Lowe JE, Curtis AB, Olsson S, Ellenbogen KA, Prystowsky EN, Halperin JL, Tamargo JL, Kay GN, Wann L; 2006 Writing Committee Members; Jacobs AK, Anderson JL, Albert N, Hochman JS, Buller CE, Kushner FG, Creager MA, Ohman EM, Ettinger SM, Stevenson WG, Guyton RA, Tarkington LG, Halperin JL, Yancy CW; ACCF/AHA Task Force Members. 2011 ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (updating the 2006 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011 Jan 4;123(1):104-23. doi: 10.1161/CIR.0b013e3181fa3cf4. Epub 2010 Dec 20. No abstract available.

  PMID: 21173346 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Tachycardia

Condition Hierarchy (Ancestors)

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

Study Officials

• Roderick Tung

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 13, 2018
• Study Start: October 31, 2018
• Primary Completion: February 24, 2021
• Study Completion: February 24, 2021
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)