Assessing the Neurological Outcomes After Atrial Fibrillation Ablation for Rhythm Control
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKansas City Heart Rhythm Research Foundation
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with atrial fibrillation (AF) and recent stroke.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Catheter Ablation
DeviceCatheter 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.
Market-approved AVNB, OAC and AAD
DrugUsed per protocol for the duration of the trial.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Routine Medication Therapy1 intervention
Group B: Atrial Fibrillation Ablation1 intervention
Trial outcomes
Primary outcomes
1
Functional neurologic outcome - Modified Rankin Scale
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)
Time frame
1 Month, 3 Months, 6 Months, 9 Months and 12 Months2
Recurrent Stroke
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.
Time frame
12 MonthsSecondary outcomes
1
Functional neurologic outcome - Quality of Life
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).
Time frame
1 Month, 3 Months, 6 Months, 9 Months and 12 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: