Assessing the Neurological Outcomes After Atrial Fibrillation Ablation for Rhythm Control
NCT ID: NCT06783868
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2025-10-31
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Routine Medication Therapy
Will receive SOC following AF diagnosis in the setting of stroke. This includes rate control with a combination of atrioventricular nodal blockers (AVNB) (Metoprolol, Diltiazem, etc.) and initiation of oral anticoagulation (OAC) (either Eliquis, Xarelto, or Warfarin) within 1-14 days per recommendations of the Stroke Team. If arrhythmia remains uncontrolled, patients will be started on an anti-arrhythmic drugs (AAD) (either Flecainide, Dofetilide, Propafenone, Sotalol, Amiodarone, etc.) per Electrophysiology. Doses of medications will be determined by the managing physician. If a patient was/is started or on triple therapy, this will be converted to appropriate anti-platelet and OAC. Patients will continue this management if AF is controlled. Patients can still undergo CA for rhythm control at the discretion of the managing Electrophysiologist.
Market-approved AVNB, OAC and AAD
Used per protocol for the duration of the trial.
Atrial Fibrillation Ablation
When randomized to this group, patients will subsequently receive earlier rhythm control. They will undergo SOC following AF diagnosis in the setting of stroke as above. This can include AVNB and OAC. However, these patients will also be assigned to start AAD before discharge from the hospital. They will subsequently undergo CA 30-120 days from discharge from the hospital. The lesions to be ablated will be determined by electrophysiology study (EPS) with electroanatomic mapping and subsequently selected by the operator to optimize each patient situation.
Catheter Ablation
Catheter Ablation is commonly performed with radiofrequency or cryotherapy to maintain a rhythm control strategy if patients can no longer tolerate their symptoms or are no longer controlled on AVNB or AAD. The procedure leads to significant symptom improvement even though there may be insignificant AF recurrence at one year. At Kansas City Heart Rhythm Institute, CA may be performed with radiofrequency ablation (Tactiflex Ablation Catheter, Abbott Cardiovascular, Minneapolis, MN) or pulsed field ablation (PulseSelectTM, Abbott Cardiovascular or FaraWaveTM, Boston Scientific, Marlborough, MA), performed with EnsiteX (Abbott Cardiovascular) or Carto3 (Biosense Webster, Irvine, CA) mapping software.
Interventions
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Catheter Ablation
Catheter Ablation is commonly performed with radiofrequency or cryotherapy to maintain a rhythm control strategy if patients can no longer tolerate their symptoms or are no longer controlled on AVNB or AAD. The procedure leads to significant symptom improvement even though there may be insignificant AF recurrence at one year. At Kansas City Heart Rhythm Institute, CA may be performed with radiofrequency ablation (Tactiflex Ablation Catheter, Abbott Cardiovascular, Minneapolis, MN) or pulsed field ablation (PulseSelectTM, Abbott Cardiovascular or FaraWaveTM, Boston Scientific, Marlborough, MA), performed with EnsiteX (Abbott Cardiovascular) or Carto3 (Biosense Webster, Irvine, CA) mapping software.
Market-approved AVNB, OAC and AAD
Used per protocol for the duration of the trial.
Eligibility Criteria
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Inclusion Criteria
* Presenting with an acute stroke and new-onset AF
* Modified RANKIN score (mRS) \< 6
* Must be able to undergo some form of cardiac monitoring \[implantable loop recorder (ILR), electrocardiogram (ECG), Holter monitor\] to quantify AF burden
Exclusion Criteria
* Unable to provide consent, including mRS = 6.
* Not able to read and write at an 8th-grade level \[to complete AFEQT and EQ-5D surveys\]
* Positive B-hCG
* Will not follow up with our practice/clinic afterward.
* Cannot tolerate OAC or AAD for any reason.
* Cannot undergo CA for any reason.
18 Years
ALL
No
Sponsors
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Kansas City Heart Rhythm Research Foundation
OTHER
Responsible Party
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Principal Investigators
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Dhanunjaya Lakkireddy, MD
Role: PRINCIPAL_INVESTIGATOR
Kansas City Heart Rhythm Institute
Locations
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Menorah Medical Center
Overland Park, Kansas, United States
Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, Kansas, United States
Overland Park Regional Medical Center
Overland Park, Kansas, United States
Centerpoint Medical Center Clinic
Independence, Missouri, United States
Centerpoint Medical Center
Independence, Missouri, United States
Research Medical Center Clinic
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
Countries
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Central Contacts
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References
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About Stroke. 2023
What is Atrial Fibrillation.2023
Roman S, Patel K, Hana D, Guice KC, Patel J, Stadnick C, Basta A, Khouzam RN. Rate versus rhythm control for atrial fibrillation: from AFFIRM to EAST-AFNET 4 - a paradigm shift. Future Cardiol. 2022 Apr;18(4):354-353. doi: 10.2217/fca-2021-0034. Epub 2022 Mar 8.
Kirchhof P, Camm AJ, Goette A, Brandes A, Eckardt L, Elvan A, Fetsch T, van Gelder IC, Haase D, Haegeli LM, Hamann F, Heidbuchel H, Hindricks G, Kautzner J, Kuck KH, Mont L, Ng GA, Rekosz J, Schoen N, Schotten U, Suling A, Taggeselle J, Themistoclakis S, Vettorazzi E, Vardas P, Wegscheider K, Willems S, Crijns HJGM, Breithardt G; EAST-AFNET 4 Trial Investigators. Early Rhythm-Control Therapy in Patients with Atrial Fibrillation. N Engl J Med. 2020 Oct 1;383(14):1305-1316. doi: 10.1056/NEJMoa2019422. Epub 2020 Aug 29.
Bunch TJ, Crandall BG, Weiss JP, May HT, Bair TL, Osborn JS, Anderson JL, Muhlestein JB, Horne BD, Lappe DL, Day JD. Patients treated with catheter ablation for atrial fibrillation have long-term rates of death, stroke, and dementia similar to patients without atrial fibrillation. J Cardiovasc Electrophysiol. 2011 Aug;22(8):839-45. doi: 10.1111/j.1540-8167.2011.02035.x. Epub 2011 Mar 15.
Park J, Shim J, Lee JM, Park JK, Heo J, Chang Y, Song TJ, Kim DH, Lee HA, Yu HT, Kim TH, Uhm JS, Kim YD, Nam HS, Joung B, Lee MH, Heo JH, Pak HN; RAFAS Investigators*. Risks and Benefits of Early Rhythm Control in Patients With Acute Strokes and Atrial Fibrillation: A Multicenter, Prospective, Randomized Study (the RAFAS Trial). J Am Heart Assoc. 2022 Feb;11(3):e023391. doi: 10.1161/JAHA.121.023391. Epub 2022 Jan 19.
Jensen M, Suling A, Metzner A, Schnabel RB, Borof K, Goette A, Haeusler KG, Zapf A, Wegscheider K, Fabritz L, Diener HC, Thomalla G, Kirchhof P. Early rhythm-control therapy for atrial fibrillation in patients with a history of stroke: a subgroup analysis of the EAST-AFNET 4 trial. Lancet Neurol. 2023 Jan;22(1):45-54. doi: 10.1016/S1474-4422(22)00436-7.
Turagam MK, Musikantow D, Whang W, Koruth JS, Miller MA, Langan MN, Sofi A, Choudry S, Dukkipati SR, Reddy VY. Assessment of Catheter Ablation or Antiarrhythmic Drugs for First-line Therapy of Atrial Fibrillation: A Meta-analysis of Randomized Clinical Trials. JAMA Cardiol. 2021 Jun 1;6(6):697-705. doi: 10.1001/jamacardio.2021.0852.
Other Identifiers
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KCHRRF_SAVE STROKE II_0037
Identifier Type: -
Identifier Source: org_study_id
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