Atrial FibrillationPhase 4TRIM-AFNCT03603912

Targeting Risk Interventions and Metformin for Atrial Fibrillation (TRIM-AF)

A Phase 4 study testing Metformin and Lifestyle/Risk Factor Modification in people with Atrial Fibrillation, run by Mina Chung, MD at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Prospective randomized open-label blinded endpoint (PROBE) 2x2 factorial study of metformin extended release up to 750 mg BID and lifestyle and risk factor modification (LRFM) in CIED patients with at least 1 ≥5 minute episode of AF over the prior 3 months. Randomization will be stratified by pacemaker vs. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: Metformin and Lifestyle/Risk Factor Modification
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 175 participants
Where: 1 siteUnited States
Study dates: 24 Aug 2018to Dec 2027
Phase: Phase 4
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

Who may be able to join

Permanent pacemaker or implantable cardioverter-defibrillator (ICD) (with or without cardiac resynchronization therapy (CRT) with an implanted atrial lead capable of providing AF diagnostics and remote monitoring.
Paroxysmal AF, or persistent AF with plans for conversion.
AF on cardiac implantable electrical device (CIED) over the past 3 months with at least 1 episode lasting ≥5 minutes.
If on an antiarrhythmic drug, then on a stable regimen for the past 3 months.
Permanent pacemaker or ICD (with or without CRT) with an implanted atrial lead capable of providing AF diagnostics and remote monitoring.
No AF on CIED over the past 6 months.
No history of AF.
Age >/=18 years old.

Who cannot join

Permanent AF with no plans to convert to sinus rhythm.
If in persistent AF, current episode >12 months in duration (current long-standing persistent AF)
NYHA Functional Class IV heart failure
On metformin or other pharmacologic therapy for diabetes mellitus.
Use of anti-retroviral protease inhibitors (e.g. ombitasvir, paritaprevir, ritonavir, dasabuvir) or topiramate.
Known sensitivity to metformin

Show all 32Show fewer

Moderate renal disease (eGFR <45 ml/min/1.73 m2)
Significant alcohol use (average >2 drinks/day)
Hepatic dysfunction - bilirubin >1.5x ULN, unless due to Gilbert's syndrome
Planned antiarrhythmic (class I or III) drug change, AF ablation/PVI procedure or cardiac surgery over the first 3 mos of the study
AF ablation/PVI procedure performed in the past 6 months
Device changed or implanted in the past 3 months
For patients on dofetilide with a pacemaker, QTc >490 ms if QRS duration is </=100 ms. If QRS duration is >100 ms, adjusted QTc >490 ms. Adjusted QTc = QTc - (QRS duration - 100 ms).
Women who are pregnant, breast-feeding or of child-bearing potential and not willing or able to use an acceptable form of contraception.
Participants considered by the investigator to be unsuitable for the study for any of the following reasons: Not agreeable for treatment with metformin or anticipated to have poor compliance on study drug treatment; inability to follow diet or exercise instructions; unwilling to attend study follow-up visits
Life expectancy less than 2 years due to concomitant disease.
Age <18 years old.
TRIM - No AF Cohort
History of AF.
NYHA Functional Class IV heart failure
On metformin or other pharmacologic therapy for diabetes mellitus.
Use of anti-retroviral protease inhibitors (e.g. ombitasvir, paritaprevir, ritonavir, dasabuvir) or topiramate.
Moderate renal disease (eGFR <45 ml/min/1.73 m2)
Significant alcohol use (average >2 drinks/day)
Hepatic dysfunction - bilirubin >1.5x ULN, unless due to Gilbert's syndrome
Planned antiarrhythmic (class I or III) drug change, cardiac surgery over the first 3 mos of the study
Device changed or implanted in the past 3 months
For patients on dofetilide with a pacemaker, QTc >490 ms if QRS duration is </=100 ms. If QRS duration is >100 ms, adjusted QTc >490 ms. Adjusted QTc = QTc - (QRS duration - 100 ms).
Women who are pregnant, breast-feeding or of child-bearing potential and not willing or able to use an acceptable form of contraception.
Participants considered by the investigator to be unsuitable for the study for any of the following reasons: Not agreeable for treatment with metformin or anticipated to have poor compliance on study drug treatment; inability to follow diet or exercise instructions; unwilling to attend study follow-up visits
Life expectancy less than 2 years due to concomitant disease.
Age <18 years old.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic
Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: Upstream Targeting for the Prevention of Atrial Fibrillation: Targeting Risk Interventions and Metformin for Atrial Fibrillation (TRIM-AF)

Read the detailed description

The purpose of this study is to perform a prospective, randomized study for the reduction of atrial fibrillation (AF) burden and progression, targeting metabolic upstream therapies. The study aims to determine if metformin and/or lifestyle/risk factor modifications reduce AF burden and progression. A secondary aim will attempt to determine clinical, genomic, and biomarker predictors of AF progression that can be used to personalize upstream therapies. This is a prospective randomized open-label blinded endpoint (PROBE) 2x2 factorial study of metformin extended release up to 750 mg twice daily and lifestyle and risk factor modification (LRFM) in patients with implanted pacemakers or defibrillators with atrial leads and at least 1 ≥5 minute episode of AF over the prior 3 months.

Conditions: Atrial Fibrillation
Being tested: Metformin, Lifestyle/Risk Factor Modification
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MetforminDrug
Also called Metformin HCL
Metformin ER 500 mg daily, titrated at 1 month intervals to 500 mg twice daily, then 750 mg twice daily, as tolerated, for 2 years.
Lifestyle/Risk Factor ModificationBehavioural
Also called LRFM
Diet/nutrition counseling and exercise prescription with follow-up visits, sleep apnea screening and treatment if detected, optimization of guideline-directed medical therapies for hypertension, coronary artery disease (CAD), hyperlipidemia and heart failure (HF).

Study groups in NCT03603912
Study group	Role	What they receive
Control	No intervention	Written educational literature on healthy eating and exercise guideline
Metformin	Experimental	Metformin ER up to 750 mg twice daily Receives: Drug: Metformin
Lifestyle/Risk Factor Modification	Experimental	Lifestyle/Risk Factor Modification (LRFM): Diet/nutrition, exercise, and risk factor modification Receives: Behavioral: Lifestyle/Risk Factor Modification
Metformin + LRFM	Experimental	Metformin ER up to 750 mg twice daily + Lifestyle/Risk Factor Modification (LRFM) diet/nutrition, exercise, and risk factor modification Receives: Drug: Metformin; Behavioral: Lifestyle/Risk Factor Modification
No Atrial Fibrillation	No intervention	Written educational literature on healthy eating and exercise guideline

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in AF burden
Composite of change from baseline to 1 year of average daily AF burden % after a 3 month blanking period and survival at 1 year.
Measured: 1 year

Secondary outcomes (32)

Total time of AF/3 mos
Total time of AF per 3 month period
Measured: 3 months, 1 year, 2 years
Average %time in AF/day
Average percent time in AF/day
Measured: 3 months, 1 year, 2 years
%change in average AF time/day
Percent change in average AF time/day from baseline
Measured: Baseline to 3 months, 1 year, 2 years
Number of days of AF
Number of days of AF over the time period
Measured: 3 months, 1 year, 2 years
Number of AF episodes/month
Number of AF episodes/month over the time period
Measured: 3 months, 1 year, 2 years
Longest duration of AF at each 3 mo. period
Longest duration at each 3 mo. period over the time period
Measured: 3 months, 1 year, 2 years
Change in AF burden without blanking period
Composite of change from baseline to 1 year of average daily AF burden % and survival at 1 year.
Measured: 1 year
AF density
a measure of AF temporal aggregation, calculated using daily AF burden time over the study period
Measured: 1 year, 2 years
Time to next AF and to persistent AF
Time to next AF and to persistent AF with and without a 3 mo. blanking period
Measured: Up to 2 years
Incidence of Persistent AF
Development of persistent AF over the study period
Measured: 3 months, 1 year, 2 years
Cardioversion for AF
Electrical cardioversion procedures over the study period
Measured: 3 months, 1 year, 2 years
AF ablation/pulmonary vein isolation (PVI) for increase in burden or persistent AF
Occurrence of AF ablation/PVI procedures over the study period.
Measured: 3 months, 1 year, 2 years
Change of antiarrhythmic drug
Change or new initiation of class I or III antiarrhythmic drug over the study period.
Measured: 3 months, 1 year, 2 years
Change in Atrial Fibrillation Symptom Score (AFSS)
Changes in Atrial Fibrillation Symptom Score (AFSS) from baseline - Global well-being (1-10), AF duration (1-8, lower denotes longer duration AF), AF severity (1-10, higher denotes more severe AF), ER visits (0-7), Hospitalizations (0-7), Specialist visits (0-7)
Measured: Baseline, 1 year, 2 years
Change in Short Form-36 (SF-36) scores
Change in SF-36 scores from baseline. SF-36 has 8 scaled scores; scores are weighted sums of the questions in each section. Scores range from 0-100 with lower scores indicating more disability, higher scores indicating less disability. Sections are: Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health.
Measured: Baseline, 1 year, 2 years
Change in physical assessment questionnaire scores: Rapid Assessment of Physical Activity (RAPA)
Change in physical assessment questionnaire score from baseline. RAPA 1 Aerobic score 1-7, high more active. RAPA 2 Strength \& Flexibility score 0-3 (higher more strength and flexibility)
Measured: Baseline, 1 year, 2 years
Change in GPCOG questionnaire score
Change in General Practitioner assessment of Cognition (GPCOG) questionnaire score from baseline. Step 1: Score 0-4 Cognitive impairment is indicated; 5-8 More information required; 9 No significant cognitive impairment
Measured: Baseline, 1 year, 2 years
Change in weight
Change in weight (pounds) from baseline
Measured: baseline, 1 year, 2 years
Change in body fat composition
Change in body fat composition (%) from baseline.
Measured: baseline, 1 year, 2 years
Change in BMI
Change in body mass index (BMI, kg/m2) from baseline (calculated from weight, height)
Measured: Baseline, 1 year, 2 years
Change in waist/hip ratio
Change in waist/hip ratio from baseline
Measured: Baseline, 1 year, 2 years
Change in HbA1c
Change in HbA1c (%) from baseline
Measured: Baseline, 1 year, 2 years
Change in total cholesterol
Change in total cholesterol from baseline
Measured: Baseline, 1 year, 2 years
Change in LDL
Change in LDL from baseline
Measured: Baseline, 1 year, 2 years
Change in HDL
Change in HDL from baseline
Measured: Baseline, 1 year, 2 years
Change in triglycerides
Change in triglycerides from baseline
Measured: Baseline, 1 year, 2 years
Change in Homeostatic Model Assessment - Insulin Resistance (HOMA-IR)
Change in HOMA-IR from baseline (calculated from fasting blood sugar and insulin)
Measured: Baseline, 1 year, 2 years
Composite Major Adverse Cardiovascular Events (MACE)
Composite incidence of cardiovascular death, nonfatal stroke, nonfatal myocardial infarction
Measured: 1 year, 2 years
All-cause mortality
Incidence of all-cause death
Measured: 1 year, 2 years
Stroke
Incidence of stroke
Measured: 1 year, 2 years
Transient ischemic attack
Incidence of transient ischemic attack
Measured: 1 year, 2 years
Activity by implanted device
Daily activity as measured by the sensors in the implanted pacemaker or defibrillator device (hours/day)
Measured: 3 months, 1 year, 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Aug 2018Dec 2027

First posted27 Jul 2018
Study start24 Aug 2018
Primary completionDec 2026 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 175 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03603912
Sponsor's protocol ID: 18-757
Acronym: TRIM-AF
Status last verified: Sep 2026
First submitted: 12 Jul 2018
Last updated: 14 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Wass SY, Barnard J, Kim HS, Sun H, Telfer W, Schilling T, Barzilai B, Bruemmer D, Cho L, Huang J, Hussein A, Kashyap SR, Laffin L, Mehra R, Moravec C, Saliba W, Sanders P, Nissen S, Varma N, Smith J, Van Wagoner D, Chung MK. Upstream targeting for the prevention of atrial fibrillation: Targeting Risk Interventions and Metformin for Atrial Fibrillation (TRIM-AF)-rationale and study design. J Interv Card Electrophysiol. 2025 Jan;68(1):9-19. doi: 10.1007/s10840-024-01955-z. Epub 2024 Dec 13.
PubMed 39671157

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Upstream Targeting for the Prevention of Atrial Fibrillation: Targeting Risk Interventions and Metformin for Atrial Fibrillation (TRIM-AF)
ClinicalTrials.gov ID: NCT03603912
Acronym / sponsor ID: TRIM-AF / 18-757
Conditions: Atrial Fibrillation
Phase: Phase 4
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 175 participants (actual)
Lead sponsor: Mina Chung, MDUniversity, hospital or other
Collaborators: American Heart Association, The Cleveland Clinic
Study start: 24 Aug 2018 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 27 Jul 2018 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Control	No intervention	–Written educational literature on healthy eating and exercise guideline
Metformin	Experimental	Drug: MetforminMetformin ER up to 750 mg twice daily
Lifestyle/Risk Factor Modification	Experimental	Behavioral: Lifestyle/Risk Factor ModificationLifestyle/Risk Factor Modification (LRFM): Diet/nutrition, exercise, and risk factor modification
Metformin + LRFM	Experimental	Drug: Metformin, Behavioral: Lifestyle/Risk Factor ModificationMetformin ER up to 750 mg twice daily + Lifestyle/Risk Factor Modification (LRFM) diet/nutrition, exercise, and risk factor modification
No Atrial Fibrillation	No intervention	–Written educational literature on healthy eating and exercise guideline

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Permanent pacemaker or implantable cardioverter-defibrillator (ICD) (with or without cardiac resynchronization therapy (CRT) with an implanted atrial lead capable of providing AF diagnostics and remote monitoring.
Paroxysmal AF, or persistent AF with plans for conversion.
AF on cardiac implantable electrical device (CIED) over the past 3 months with at least 1 episode lasting ≥5 minutes.
If on an antiarrhythmic drug, then on a stable regimen for the past 3 months.
Permanent pacemaker or ICD (with or without CRT) with an implanted atrial lead capable of providing AF diagnostics and remote monitoring.

Key exclusion criteria (32 listed)

Permanent AF with no plans to convert to sinus rhythm.
If in persistent AF, current episode >12 months in duration (current long-standing persistent AF)
NYHA Functional Class IV heart failure
On metformin or other pharmacologic therapy for diabetes mellitus.
Use of anti-retroviral protease inhibitors (e.g. ombitasvir, paritaprevir, ritonavir, dasabuvir) or topiramate.

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
MetforminAlso: Metformin HCLMetformin ER 500 mg daily, titrated at 1 month intervals to 500 mg twice daily, then 750 mg twice daily, as tolerated, for 2 years.	Drug	Metformin, Metformin + LRFM
Lifestyle/Risk Factor ModificationAlso: LRFMDiet/nutrition counseling and exercise prescription with follow-up visits, sleep apnea screening and treatment if detected, optimization of guideline-directed medical therapies for hypertension, coronary artery disease (CAD), hyperlipidemia and heart failure (HF).	Behavioural	Lifestyle/Risk Factor Modification, Metformin + LRFM

Primary outcome

Change in AF burden
Time frame: 1 year
Composite of change from baseline to 1 year of average daily AF burden % after a 3 month blanking period and survival at 1 year.

32 secondary outcomes

Total time of AF/3 mos
Time frame: 3 months, 1 year, 2 years
Average %time in AF/day
Time frame: 3 months, 1 year, 2 years
%change in average AF time/day
Time frame: Baseline to 3 months, 1 year, 2 years
Number of days of AF
Time frame: 3 months, 1 year, 2 years
Number of AF episodes/month
Time frame: 3 months, 1 year, 2 years
Longest duration of AF at each 3 mo. period
Time frame: 3 months, 1 year, 2 years
Change in AF burden without blanking period
Time frame: 1 year
AF density
Time frame: 1 year, 2 years
Time to next AF and to persistent AF
Time frame: Up to 2 years
Incidence of Persistent AF
Time frame: 3 months, 1 year, 2 years
Cardioversion for AF
Time frame: 3 months, 1 year, 2 years
AF ablation/pulmonary vein isolation (PVI) for increase in burden or persistent AF
Time frame: 3 months, 1 year, 2 years
Change of antiarrhythmic drug
Time frame: 3 months, 1 year, 2 years
Change in Atrial Fibrillation Symptom Score (AFSS)
Time frame: Baseline, 1 year, 2 years
Change in Short Form-36 (SF-36) scores
Time frame: Baseline, 1 year, 2 years
Change in physical assessment questionnaire scores: Rapid Assessment of Physical Activity (RAPA)
Time frame: Baseline, 1 year, 2 years
Change in GPCOG questionnaire score
Time frame: Baseline, 1 year, 2 years
Change in weight
Time frame: baseline, 1 year, 2 years
Change in body fat composition
Time frame: baseline, 1 year, 2 years
Change in BMI
Time frame: Baseline, 1 year, 2 years
Change in waist/hip ratio
Time frame: Baseline, 1 year, 2 years
Change in HbA1c
Time frame: Baseline, 1 year, 2 years
Change in total cholesterol
Time frame: Baseline, 1 year, 2 years
Change in LDL
Time frame: Baseline, 1 year, 2 years
Change in HDL
Time frame: Baseline, 1 year, 2 years
Change in triglycerides
Time frame: Baseline, 1 year, 2 years
Change in Homeostatic Model Assessment - Insulin Resistance (HOMA-IR)
Time frame: Baseline, 1 year, 2 years
Composite Major Adverse Cardiovascular Events (MACE)
Time frame: 1 year, 2 years
All-cause mortality
Time frame: 1 year, 2 years
Stroke
Time frame: 1 year, 2 years
Transient ischemic attack
Time frame: 1 year, 2 years
Activity by implanted device
Time frame: 3 months, 1 year, 2 years

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 14 Sep 2026.
Derived from this study: PubMed 39671157Wass SY, Barnard J, Kim HS, Sun H, Telfer W, Schilling T, Barzilai B, Bruemmer D, Cho L, Huang J, Hussein A, Kashyap SR, Laffin L, Mehra R, Moravec C, Saliba W, Sanders P, Nissen S, Varma N, Smith J, Van Wagoner D, Chung MK. Upstream targeting for the prevention of atrial fibrillation: Targeting Risk Interventions and Metformin for Atrial Fibrillation (TRIM-AF)-rationale and study design. J Interv Card Electrophysiol. 2025 Jan;68(1):9-19. doi: 10.1007/s10840-024-01955-z. Epub 2024 Dec 13.
Individual participant dataSharing planned: No

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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. This study is not recruiting at the moment.

Mina K Chung, MD principal investigator

The Cleveland Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metformin and Lifestyle/Risk Factor Modification in people with Atrial Fibrillation, run by Mina Chung, MD at 1 site 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 8 inclusion and 32 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: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in AF burden (time frame: 1 year). 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 NCT03603912, which also lists 1 linked publication.

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 14 Sep 2026.