Assessing the Neurological Outcomes After Atrial Fibrillation Ablation for Rhythm Control

Last updated: August 27, 2025
Sponsor: Kansas City Heart Rhythm Research Foundation
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cerebral Ischemia

Arrhythmia

Chest Pain

Treatment

Market-approved AVNB, OAC and AAD

Catheter Ablation

Clinical Study ID

NCT06783868
KCHRRF_SAVE STROKE II_0037
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion

Exclusion Criteria:

  • 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-5Dsurveys]

  • 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.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Market-approved AVNB, OAC and AAD
Phase:
Study Start date:
October 01, 2025
Estimated Completion Date:
June 30, 2027

Study Description

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.

Connect with a study center

  • Kansas City Heart Rhythm Institute - Roe Clinic

    Overland Park, Kansas 66211
    United States

    Site Not Available

  • Menorah Medical Center

    Overland Park, Kansas 66209
    United States

    Site Not Available

  • Overland Park Regional Medical Center

    Overland Park, Kansas 66215
    United States

    Site Not Available

  • Kansas City Heart Rhythm Institute - Roe Clinic

    Overland Park 4276873, Kansas 4273857 66211
    United States

    Site Not Available

  • Menorah Medical Center

    Overland Park 4276873, Kansas 4273857 66209
    United States

    Site Not Available

  • Overland Park Regional Medical Center

    Overland Park 4276873, Kansas 4273857 66215
    United States

    Site Not Available

  • Centerpoint Medical Center

    Independence, Missouri 64057
    United States

    Site Not Available

  • Centerpoint Medical Center Clinic

    Independence, Missouri 64057
    United States

    Site Not Available

  • Research Medical Center

    Kansas City, Missouri 64032
    United States

    Site Not Available

  • Research Medical Center Clinic

    Kansas City, Missouri 64032
    United States

    Site Not Available

  • Centerpoint Medical Center

    Independence 4391812, Missouri 4398678 64057
    United States

    Site Not Available

  • Centerpoint Medical Center Clinic

    Independence 4391812, Missouri 4398678 64057
    United States

    Site Not Available

  • Research Medical Center

    Kansas City 4393217, Missouri 4398678 64032
    United States

    Site Not Available

  • Research Medical Center Clinic

    Kansas City 4393217, Missouri 4398678 64032
    United States

    Site Not Available

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