Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-29 @ 9:57 AM
Study NCT ID:
NCT06783868
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-28
First Post:
2025-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Neurological Outcomes After Atrial Fibrillation Ablation for Rhythm Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017115', 'term': 'Catheter Ablation'}], 'ancestors': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}, {'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2025-01-14', 'studyFirstSubmitQcDate': '2025-01-14', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional neurologic outcome - Modified Rankin Scale', 'timeFrame': '1 Month, 3 Months, 6 Months, 9 Months and 12 Months', 'description': '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)'}, {'measure': 'Recurrent Stroke', 'timeFrame': '12 Months', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Functional neurologic outcome - Quality of Life', 'timeFrame': '1 Month, 3 Months, 6 Months, 9 Months and 12 Months', 'description': '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.\n\nA 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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation', 'Stroke']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'About Stroke. 2023'}, {'type': 'BACKGROUND', 'citation': 'What is Atrial Fibrillation.2023'}, {'pmid': '35255732', 'type': 'BACKGROUND', 'citation': 'Roman S, Patel K, Hana D, Guice KC, Patel J, Stadnick C, Basta A, Khouzam RN. Rate versus rhythm control for atrial fibrillation: from AFFIRM to EAST-AFNET 4 - a paradigm shift. Future Cardiol. 2022 Apr;18(4):354-353. doi: 10.2217/fca-2021-0034. Epub 2022 Mar 8.'}, {'pmid': '32865375', 'type': 'BACKGROUND', 'citation': 'Kirchhof P, Camm AJ, Goette A, Brandes A, Eckardt L, Elvan A, Fetsch T, van Gelder IC, Haase D, Haegeli LM, Hamann F, Heidbuchel H, Hindricks G, Kautzner J, Kuck KH, Mont L, Ng GA, Rekosz J, Schoen N, Schotten U, Suling A, Taggeselle J, Themistoclakis S, Vettorazzi E, Vardas P, Wegscheider K, Willems S, Crijns HJGM, Breithardt G; EAST-AFNET 4 Trial Investigators. Early Rhythm-Control Therapy in Patients with Atrial Fibrillation. N Engl J Med. 2020 Oct 1;383(14):1305-1316. doi: 10.1056/NEJMoa2019422. Epub 2020 Aug 29.'}, {'pmid': '21410581', 'type': 'BACKGROUND', 'citation': 'Bunch TJ, Crandall BG, Weiss JP, May HT, Bair TL, Osborn JS, Anderson JL, Muhlestein JB, Horne BD, Lappe DL, Day JD. Patients treated with catheter ablation for atrial fibrillation have long-term rates of death, stroke, and dementia similar to patients without atrial fibrillation. J Cardiovasc Electrophysiol. 2011 Aug;22(8):839-45. doi: 10.1111/j.1540-8167.2011.02035.x. Epub 2011 Mar 15.'}, {'pmid': '35043663', 'type': 'BACKGROUND', 'citation': 'Park J, Shim J, Lee JM, Park JK, Heo J, Chang Y, Song TJ, Kim DH, Lee HA, Yu HT, Kim TH, Uhm JS, Kim YD, Nam HS, Joung B, Lee MH, Heo JH, Pak HN; RAFAS Investigators*. Risks and Benefits of Early Rhythm Control in Patients With Acute Strokes and Atrial Fibrillation: A Multicenter, Prospective, Randomized Study (the RAFAS Trial). J Am Heart Assoc. 2022 Feb;11(3):e023391. doi: 10.1161/JAHA.121.023391. Epub 2022 Jan 19.'}, {'pmid': '36517170', 'type': 'BACKGROUND', 'citation': 'Jensen M, Suling A, Metzner A, Schnabel RB, Borof K, Goette A, Haeusler KG, Zapf A, Wegscheider K, Fabritz L, Diener HC, Thomalla G, Kirchhof P. Early rhythm-control therapy for atrial fibrillation in patients with a history of stroke: a subgroup analysis of the EAST-AFNET 4 trial. Lancet Neurol. 2023 Jan;22(1):45-54. doi: 10.1016/S1474-4422(22)00436-7.'}, {'pmid': '33909022', 'type': 'BACKGROUND', 'citation': 'Turagam MK, Musikantow D, Whang W, Koruth JS, Miller MA, Langan MN, Sofi A, Choudry S, Dukkipati SR, Reddy VY. Assessment of Catheter Ablation or Antiarrhythmic Drugs for First-line Therapy of Atrial Fibrillation: A Meta-analysis of Randomized Clinical Trials. JAMA Cardiol. 2021 Jun 1;6(6):697-705. doi: 10.1001/jamacardio.2021.0852.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with atrial fibrillation (AF) and recent stroke.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages \\>18 and able to provide consent.\n* Presenting with an acute stroke and new-onset AF\n* Modified RANKIN score (mRS) \\< 6\n* Must be able to undergo some form of cardiac monitoring \\[implantable loop recorder (ILR), electrocardiogram (ECG), Holter monitor\\] to quantify AF burden\n\nExclusion Criteria:\n\n* Patients \\< 18 years of age\n* Unable to provide consent, including mRS = 6.\n* Not able to read and write at an 8th-grade level \\[to complete AFEQT and EQ-5D surveys\\]\n* Positive B-hCG\n* Will not follow up with our practice/clinic afterward.\n* Cannot tolerate OAC or AAD for any reason.\n* Cannot undergo CA for any reason.'}, 'identificationModule': {'nctId': 'NCT06783868', 'acronym': 'SAVE STROKE II', 'briefTitle': 'Assessing the Neurological Outcomes After Atrial Fibrillation Ablation for Rhythm Control', 'organization': {'class': 'OTHER', 'fullName': 'Kansas City Heart Rhythm Research Foundation'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'KCHRRF_SAVE STROKE II_0037'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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.', 'interventionNames': ['Drug: Market-approved AVNB, OAC and AAD']}, {'label': '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.', 'interventionNames': ['Device: Catheter Ablation']}], 'interventions': [{'name': 'Catheter Ablation', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Atrial Fibrillation Ablation']}, {'name': 'Market-approved AVNB, OAC and AAD', 'type': 'DRUG', 'description': 'Used per protocol for the duration of the trial.', 'armGroupLabels': ['Routine Medication Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66209', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Menorah Medical Center', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas City Heart Rhythm Institute - Roe Clinic', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '66215', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Overland Park Regional Medical Center', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '64057', 'city': 'Independence', 'state': 'Missouri', 'country': 'United States', 'facility': 'Centerpoint Medical Center Clinic', 'geoPoint': {'lat': 39.09112, 'lon': -94.41551}}, {'zip': '64057', 'city': 'Independence', 'state': 'Missouri', 'country': 'United States', 'facility': 'Centerpoint Medical Center', 'geoPoint': {'lat': 39.09112, 'lon': -94.41551}}, {'zip': '64032', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Medical Center Clinic', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '64032', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Medical Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'centralContacts': [{'name': 'Donita Atkins', 'role': 'CONTACT', 'email': 'datkins@kchrf.com', 'phone': '816-651-1969'}], 'overallOfficials': [{'name': 'Dhanunjaya Lakkireddy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kansas City Heart Rhythm Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kansas City Heart Rhythm Research Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}