Atrial FibrillationPANACEA-AFNCT03737838
Propagation ANalysis for Arrhythmogenic Conduction Elimination to Prevent Atrial Flutter and Fibrillation (PANACEA-AF)
An observational study of Atrial Fibrillation, run by University of Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Atrial fibrillation ablation
- Type of treatment
- Medical device
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2018to 24 Feb 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prospective cohort of patients with AF refractory to prior ablation
Who may be able to join
- Patients at least 18 years of age
- Re-do AF ablation with history of PVI
- Undergone at least 1 prior ablation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Propagation ANalysis for Arrhythmogenic Conduction Elimination to Prevent Atrial Flutter and Fibrillation
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.
Read the detailed description
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
- Conditions
- Atrial Fibrillation
- Being tested
- Atrial fibrillation ablation
- Keywords
- Paroxysmal, Atrial, Fibrillation, Ventricular, Tachycardia
- Medical subject headings
- Atrial Fibrillation, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial fibrillation ablationDevice
High density mapping of left atrium using Rhythmia mapping system to identify gaps in conduction and wavefront discontinuities (deceleration zones)
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from recurrent atrial fibrillation and atrial flutter
Freedom from atrial arrhythmias
Measured: Baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start31 Oct 2018
- Primary completion24 Feb 2021
- Study completion24 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roderick Tung, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737838
- Sponsor's protocol ID
- IRB17-1769
- Acronym
- PANACEA-AF
- Status last verified
- May 2024
- First submitted
- 5 Nov 2018
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 27440005Verma 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.
PubMed 25946280Irie 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.
PubMed 25740836Anter 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.
PubMed 27262767Viswanathan 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.
PubMed 27867071Luther 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.
PubMed 28356307Ciaccio 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.
PubMed 15028069Anter 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.
PubMed 26001505Wann 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.
PubMed 21173346
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propagation ANalysis for Arrhythmogenic Conduction Elimination to Prevent Atrial Flutter and Fibrillation
- ClinicalTrials.gov ID
- NCT03737838
- Acronym / sponsor ID
- PANACEA-AF / IRB17-1769
- Conditions
- Atrial Fibrillation
- Keywords
- Paroxysmal, Atrial, Fibrillation, Ventricular, Tachycardia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective cohort of patients with AF refractory to prior ablation
Key inclusion criteria (3 listed)
- Patients at least 18 years of age
- Re-do AF ablation with history of PVI
- Undergone at least 1 prior ablation
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atrial fibrillation ablationHigh density mapping of left atrium using Rhythmia mapping system to identify gaps in conduction and wavefront discontinuities (deceleration zones) | Device | – |
Primary outcome
Freedom from recurrent atrial fibrillation and atrial flutter
Time frame: Baseline to 1 year
Freedom from atrial arrhythmias
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Background: PubMed 27440005Anter 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.
- Background: PubMed 25946280Verma 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.
- Background: PubMed 25740836Irie 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.
- Background: PubMed 27262767Anter 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.
- Background: PubMed 27867071Viswanathan 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.
- Background: PubMed 28356307Luther 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.
- Background: PubMed 15028069Ciaccio 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.
- Background: PubMed 26001505Anter 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.
- Background: PubMed 21173346Wann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roderick Tung principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from recurrent atrial fibrillation and atrial flutter (time frame: Baseline to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03737838, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.