Assessing the Neurological Outcomes After Atrial Fibrillation Ablation for Rhythm Control

NCT06783868 | Not Yet Recruiting FDA Drug FDA Device

• 1 other identifier: KCHRRF_SAVE STROKE II_0037
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 7

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.

Conditions

Atrial Fibrillation; Stroke

Outcome Measures

Primary Outcomes (2)

• 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)

  1 Month, 3 Months, 6 Months, 9 Months and 12 Months

• 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.

  12 Months

Secondary Outcomes (1)

• Functional neurologic outcome - Quality of Life

  1 Month, 3 Months, 6 Months, 9 Months and 12 Months

Study Arms (2)

Routine Medication Therapy

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.

Drug: Market-approved AVNB, OAC and AAD

Atrial Fibrillation Ablation

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.

Device: Catheter Ablation

Interventions

Catheter Ablation DEVICE

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.

Atrial Fibrillation Ablation

Market-approved AVNB, OAC and AAD DRUG

Used per protocol for the duration of the trial.

Routine Medication Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with atrial fibrillation (AF) and recent stroke.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kansas City Heart Rhythm Research Foundation: lead

Study Sites (7)

Menorah Medical Center

Overland Park, Kansas, 66209, United States

Location

Kansas City Heart Rhythm Institute - Roe Clinic

Overland Park, Kansas, 66211, United States

Location

Overland Park Regional Medical Center

Overland Park, Kansas, 66215, United States

Location

Centerpoint Medical Center Clinic

Independence, Missouri, 64057, United States

Location

Centerpoint Medical Center

Independence, Missouri, 64057, United States

Location

Research Medical Center Clinic

Kansas City, Missouri, 64032, United States

Location

Research Medical Center

Kansas City, Missouri, 64032, United States

Location

Related Publications (8)

• About Stroke. 2023

  BACKGROUND

• What is Atrial Fibrillation.2023

  BACKGROUND

• 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: 35255732 BACKGROUND

• 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: 32865375 BACKGROUND

• 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: 21410581 BACKGROUND

• 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: 35043663 BACKGROUND

• 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: 36517170 BACKGROUND

• 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.

  PMID: 33909022 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Dhanunjaya Lakkireddy, MD

  Kansas City Heart Rhythm Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donita Atkins

CONTACT

816-651-1969; datkins@kchrf.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 28, 2025

Record last verified: 2025-03

Locations

US (7)