Assessing the Neurological Outcomes After Atrial Fibrillation Ablation for Rhythm Control

Официальное название

Randomized Control Study to Assess the Neurological Outcomes After Atrial Fibrillation Ablation for Rhythm Control vs Routine Medication Therapy in Patients With Recent Stroke: SAVE STROKE Phase II Study

Обзор

A prospective, non-blinded, multi-center study to assess the impact of early Catheter Ablation (CA) in patients with a new diagnosis of Atrial Fibrillation(AF) at the time of stroke. 100 patients will be enrolled.

Подробное описание

A prospective, non-blinded, multi-center study to assess the impact of early CA in patients with a new diagnosis of AF at the time of stroke. At least 100 patients who meet the inclusion and exclusion criteria will be randomized 1:1 to receive early CA or SOC (Standard of Care). The primary outcome will be the functional neurologic outcomes, including mRS (modified Rankin Scale) and QOL(Quality of Life), recurrence, major bleeding, and mortality after stroke for each group. Secondary outcomes will be changes in cognitive assessment, success of rhythm control, recurrent hospitalizations, and cumulative cardiovascular outcomes. Participants will be followed at 3, 6, 9, and 12 months following the discharge date to measure these outcomes, and the study will enroll for one year. The primary endpoints will be functional recovery and enrollment.

Вмешательства

• Устройство 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 fiel
• Препарат Market-approved AVNB, OAC and AAD
  Used per protocol for the duration of the trial.

Первичные конечные точки

• Functional neurologic outcome - Modified Rankin Scale [Срок оценки: 1 Month, 3 Months, 6 Months, 9 Months and 12 Months]
• Recurrent Stroke [Срок оценки: 12 Months]

Вторичные конечные точки (1)

• Functional neurologic outcome - Quality of Life [Срок оценки: 1 Month, 3 Months, 6 Months, 9 Months and 12 Months]

Критерии участия

Критерии включения

• Ages >18 and able to provide consent.
• 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

Критерии исключения

• Patients < 18 years of age
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

США · 7 центров

• Menorah Medical Center — Overland Park
• Kansas City Heart Rhythm Institute - Roe Clinic — Overland Park
• Overland Park Regional Medical Center — Overland Park
• Centerpoint Medical Center Clinic — Independence
• Centerpoint Medical Center — Independence
• Research Medical Center Clinic — Kansas City
• Research Medical Center — Kansas City

Публикации

• 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. PMID 35255732
• 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 Pa PMID 32865375
• 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. PMID 21410581
• 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.121.02339 PMID 35043663
• 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. PMID 36517170
• 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. PMID 33909022

Идентификаторы

NCT: NCT06783868 · KCHRRF_SAVE STROKE II_0037

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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