Atrial Fibrillation, Stroke
Conditions
Brief 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.
Detailed 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.
Interventions
DEVICECatheter 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.
DRUGMarket-approved AVNB, OAC and AAD
Used per protocol for the duration of the trial.
Sponsors
Kansas City Heart Rhythm Research Foundation
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional neurologic outcome - Modified Rankin Scale | 1 Month, 3 Months, 6 Months, 9 Months and 12 Months | Modified Rankin Scale is widely used to assess neurologic dysfunction in a broad range of neurologic and neurosurgical conditions. It is a 6-level ordinal outcome scale (0-5) used to assess the functional status of patients, encoding the range from no symptoms or functional impairment (mRS = 0) to severe disability requiring constant nursing care (mRS = 5) |
| Recurrent Stroke | 12 Months | A recurrent stroke is when a person has another stroke following their first stroke. Experiencing one can have a major impact on a person's quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional neurologic outcome - Quality of Life | 1 Month, 3 Months, 6 Months, 9 Months and 12 Months | The AF Effect on Quality-of-Life questionnaire - AFEQT for short - is a reliable and responsive measure of quality of life, developed especially for atrial fibrillation. Overall or subscale scores range from 0-100. A score of 0 corresponds to complete disability (or responding extremely limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding not at all limited, difficult or bothersome to all questions answered). |
Countries
United States
Contacts
Primary ContactDonita Atkins
Outcome results
None listed