Atrial FibrillationSAVE STROKE IINCT06783868
Assessing the Neurological Outcomes After Atrial Fibrillation Ablation for Rhythm Control
An observational study of Atrial Fibrillation and Stroke, run by Kansas City Heart Rhythm Research Foundation at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke
- What is being tested?
- Catheter Ablation and Market-approved AVNB, OAC and AAD
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 100 participants
- Where
- 7 sitesUnited States
- Study dates
- Oct 2025to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with atrial fibrillation (AF) and recent stroke.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites
Centerpoint Medical Center Clinic
Independence, Missouri, 64057
Centerpoint Medical Center
Independence, Missouri, 64057
Research Medical Center Clinic
Kansas City, Missouri, 64032
Research Medical Center
Kansas City, Missouri, 64032
Menorah Medical Center
Overland Park, Kansas, 66209
Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, Kansas, 66211
Overland Park Regional Medical Center
Overland Park, Kansas, 66215
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- Catheter Ablation, Market-approved AVNB, OAC and AAD
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter AblationDevice
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.
Market-approved AVNB, OAC and AADDrug
Used per protocol for the duration of the trial.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Catheter Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 12 Months
Secondary 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).
Measured: 1 Month, 3 Months, 6 Months, 9 Months and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study startOct 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kansas City Heart Rhythm Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dhanunjaya Lakkireddy, MD, Principal investigator, Kansas City Heart Rhythm Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783868
- Sponsor's protocol ID
- KCHRRF_SAVE STROKE II_0037
- Acronym
- SAVE STROKE II
- Status last verified
- Mar 2025
- First submitted
- 14 Jan 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
About Stroke. 2023
What is Atrial Fibrillation.2023
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.
PubMed 35255732Kirchhof 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.
PubMed 32865375Bunch 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.
PubMed 21410581Park 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.
PubMed 35043663Jensen 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.
PubMed 36517170Turagam 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.
PubMed 33909022
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06783868
- Acronym / sponsor ID
- SAVE STROKE II / KCHRRF_SAVE STROKE II_0037
- Conditions
- Atrial Fibrillation, Stroke
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kansas City Heart Rhythm Research FoundationUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Medication Therapy | – | Drug: Market-approved AVNB, OAC and AADWill 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. |
| Atrial Fibrillation Ablation | – | Device: Catheter AblationWhen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with atrial fibrillation (AF) and recent stroke.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter AblationCatheter 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. | Device | Atrial Fibrillation Ablation |
| Market-approved AVNB, OAC and AADUsed per protocol for the duration of the trial. | Drug | Routine Medication Therapy |
Primary outcome
Functional neurologic outcome - Modified Rankin Scale
Time frame: 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
Time frame: 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.
1 secondary outcome
Functional neurologic outcome - Quality of Life
Time frame: 1 Month, 3 Months, 6 Months, 9 Months and 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- BackgroundAbout Stroke. 2023
- BackgroundWhat is Atrial Fibrillation.2023
- Background: PubMed 35255732Roman 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.
- Background: PubMed 32865375Kirchhof 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.
- Background: PubMed 21410581Bunch 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.
- Background: PubMed 35043663Park 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.
- Background: PubMed 36517170Jensen 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.
- Background: PubMed 33909022Turagam 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.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dhanunjaya Lakkireddy, MD principal investigator
Kansas City Heart Rhythm Institute
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Stroke, run by Kansas City Heart Rhythm Research Foundation at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donita Atkins (816-651-1969, datkins@kchrf.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional neurologic outcome - Modified Rankin Scale (time frame: 1 Month, 3 Months, 6 Months, 9 Months and 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06783868, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.