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

Kansas City Heart Rhythm Research Foundation

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.

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 cu…

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

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 f…

Interventions

Device
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.
Drug
Market-approved AVNB, OAC and AAD
Used per protocol for the duration of the trial.

Locations (7)

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