Skip to main content
OpenTrials
Completed

NCT Number: NCT03737838

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Chicago

Chicago, Illinois, 60637, United States

About this study

Catheter ablation (CA) is a class 1 indication for patients with symptomatic drug-refractory atrial fibrillation (AF). With standard pulmonary vein isolation (PVI), the success rate ranges from 60-80% in patients with paroxysmal AF. Despite PVI, certain patients have recurrent AF and often require a repeat ablation procedure.

There is no standard ablation strategy for patients who undergo repeat ablation for recurrent AF. The largest randomized trial to date comparing ablation strategies found that the addition of LA roof and mitral isthmus ablation lines or ablation of LA ganglia was no better than standard PVI. Moreover, the addition of ablation lines in the LA, if not complete, may be pro-arrhythmic and lead to the development of LA AFL, which is often more symptomatic that AF itself.

Ultra-high density mapping during sinus rhythm allows for rapid creation of isochronal late activation maps (ILAM) in patients with ventricular tachycardia. To date, creating ILAM of the LA has not been reported and it is not known whether additional ablation in these areas improves freedom from all atrial tachyarrhythmias at 1 year follow-up. Moreover, ablation at the deceleration zones and/or gaps identified using ultra-high density mapping is a promising strategy to improve ablation success and decrease the potential for recurrent AF.

The rationale of the study is two-fold.

  • This study would be the first to report ILAM in the LA and confirm that the diseased LA may behave similarly to the diseased left or right ventricle.
  • Ablation of gaps and/or deceleration zones in the LA would be a novel approach to treat patients with recurrent AF after initial PVI, and if successful, provide another strategy to treat these refractory problems.

Co-PIs:

Hemal Nayak, MD Guarav Upadhyay, MD Andrew Beaser, MD Zaid Aziz, MD

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Atrial fibrillation ablation

Device

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

Primary outcomes

  1. Freedom from recurrent atrial fibrillation and atrial flutter

    Time frame: Baseline to 1 year

    Freedom from atrial arrhythmias

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Propagation ANalysis for Arrhythmogenic Conduction Elimination to Prevent Atrial Flutter and Fibrillation

Acronym: PANACEA-AF

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 13, 2018
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.