Assessing the Neurological Outcomes After Atrial Fibrillation Ablation for Rhythm Control (SAVE STROKE II)

Kansas City Heart Rhythm Research Foundation

Status: Not yet enrolling

Conditions: Atrial Fibrillation; Stroke

Treatments: Drug: Market-approved AVNB, OAC and AAD; Device: Catheter Ablation

Study type: Observational

Funder types: Other

Identifiers

NCT06783868

KCHRRF_SAVE STROKE II_0037

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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-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.

Trial design

100 participants in 2 patient groups

Routine Medication Therapy

Description:

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.

Treatment:

Drug: Market-approved AVNB, OAC and AAD

Atrial Fibrillation Ablation

Description:

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.

Treatment:

Device: Catheter Ablation