Cardiovascular DiseasePhase 3NCT02178410
VITAL Rhythm Study
A Phase 3 study testing Vitamin D3 and Omega-3 fatty acids (fish oil) in people with Cardiovascular Disease, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The VITamin D and OmegA-3 TriaL (VITAL) is an ongoing randomized clinical trial of 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in individuals… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Vitamin D3 and Omega-3 fatty acids (fish oil)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25,119 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Oct 2026
- Phase
- Phase 3
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- physician diagnosis of atrial fibrillation after randomization
- and/or
- cardiovascular death
Who cannot join
- physician diagnosis of atrial fibrillation prior to randomization
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02215
About this study
Official title: Vitamin D and Omega-3 Trial (VITAL Rhythm Study)
The VITamin D and OmegA-3 TriaL (VITAL) is an ongoing randomized clinical trial of 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in individuals who do not have a prior history of these illnesses. The purpose of this ancillary study is to ascertain and adjudicate atrial fibrillation (AF) outcomes for the primary aim of testing whether omega-3 fatty acid and/or vitamin D supplementation influence atrial fibrillation risk in the general population. We also plan to examine how these agents might impact the development of AF subtypes (persistent versus paroxysmal), intermediate phenotypes for heart rhythm disorders (electrocardiographic parameters), as well as explore effects on arrhythmic death and whether baseline blood levels and/or race modify treatment effects.
Read the detailed description
Atrial fibrillation and sudden cardiac death assessments, as well as blood analyses, will be conducted on the entire VITAL Study population, and ECG analyses will be limited to the Clinical and Translational Science Center (CTSC) sub-cohort of 1,054 VITAL participants who live near the Boston area and agree to participate in a series of ancillary studies in addition to the main trial.
Investigators will ascertain atrial fibrillation events utilizing self-report of physician diagnoses of atrial fibrillation received on annual questionnaires from study participants supplemented by outpatient and hospital visits for AF identified through Centers for Medicare and Medicaid Services (CMS) data linkage. Investigators will also ascertain additional information regarding atrial fibrillation diagnosis from supplementary questionnaires, and seek consent to review all inpatient and outpatient hospital records pertaining to atrial fibrillation diagnosis and evaluation. Atrial fibrillation events will be confirmed by an endpoint committee composed of cardiologists, which will also make a determination on atrial fibrillation subtype and pattern. Questionnaires that inquire about recurrent atrial fibrillation events, pattern of AF, latest medical record evaluation and treatments for AF will be sent to participants with confirmed atrial fibrillation. Medical records will be requested and reviewed an endpoint committee to determine atrial fibrillation subtype and progression. An intention-to-treat analysis examining the 5-year treatment effects of omega-3 fatty acids and vitamin D on incident atrial fibrillation, as well as subtypes at the time of diagnosis will be performed to address the primary aims. We will repeat these analyses at the end of extended follow-up to assess cumulative and post-treatment effects of omega-3 fatty acids and vitamin D and AF subtypes two years after diagnosis.
Electrocardiograms will be obtained at baseline and again after two years of treatment and follow-up among a sub-cohort of 1,054 patients being enrolled in VITAL at the CTSC. Investigators will utilize these ECG data to evaluate whether treatment with omega-3 fatty acids and vitamin D3 have significant effects on ECG measures. The ECGs will also be utilized to estimate the prevalence of asymptomatic persistent atrial fibrillation in our population not detected by our atrial fibrillation surveillance methods.
Investigators will examine baseline blood samples for participants with confirmed atrial fibrillation for the purpose of exploring whether the effect of vitamin D3 or fish oil supplementation on atrial fibrillation risk varies by the baseline blood levels of these nutrients.
Investigators will also seek additional information necessary to classify deaths as sudden or arrhythmic in origin, and cardiac deaths will be reviewed by an endpoint committee of cardiologists. Once these results have been compiled investigators will explore whether omega-3 fatty acids and/or vitamin D might have an effect on sudden and/or arrhythmic cardiac death.
- Conditions
- Cardiovascular Disease
- Being tested
- Vitamin D3, Omega-3 fatty acids (fish oil), Fish oil placebo, Vitamin D3 placebo
- Keywords
- Atrial Fibrillation, Vitamin D3, Omega-3 fatty acids, Fish oil
- Medical subject headings
- Cardiovascular Diseases, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called cholecalciferol
Vitamin D3 (cholecalciferol), 2000 IU per day.
Omega-3 fatty acids (fish oil)Drug
Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
Fish oil placeboDietary supplement
Fish oil placebo
Vitamin D3 placeboDietary supplement
Vitamin D3 placebo
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D + fish oil | Active comparator | Not described Receives: Dietary Supplement: Vitamin D3; Drug: Omega-3 fatty acids (fish oil) |
| Vitamin D + fish oil placebo | Active comparator | Not described Receives: Dietary Supplement: Vitamin D3; Dietary Supplement: Fish oil placebo |
| Vitamin D placebo + fish oil | Active comparator | Not described Receives: Drug: Omega-3 fatty acids (fish oil); Dietary Supplement: Vitamin D3 placebo |
| Vitamin D placebo + fish oil placebo | Placebo comparator | Not described Receives: Dietary Supplement: Fish oil placebo; Dietary Supplement: Vitamin D3 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial Fibrillation
To assess whether omega-3 fatty acids (Omacor® 840 mg eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) or vitamin D3 supplementation influences risk of atrial fibrillation in a general population of men and women without prior cardiovascular disease.
Measured: 7 years
Secondary outcomes (2)
Atrial Fibrillation
To examine the short and long-term impacts of vitamin D3 and EPA+DHA supplementation on the development of AF subtypes.
Measured: 7 years
Arrhythmic endpoints
To examine the effect of vitamin D3 or EPA+DHA supplementation on electrocardiographic parameters to further understand mechanisms underlying associations with arrhythmic endpoints.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startOct 2012
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25,119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Cedars-Sinai Medical Center
- Responsible party
- Principal investigator, Christine M. Albert, MD, MPH, Brigham and Women's Hospital
- Investigators
- Christine M. Albert, M.D., M.P.H., Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178410
- Sponsor's protocol ID
- 2012P002146
- Other IDs
- R01HL116690
- Status last verified
- Oct 2025
- First submitted
- 25 Jun 2014
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Qian F, Tintle N, Jensen PN, Lemaitre RN, Imamura F, Feldreich TR, Nomura SO, Guan W, Laguzzi F, Kim E, Virtanen JK, Steur M, Bork CS, Hirakawa Y, O'Donoghue ML, Sala-Vila A, Ardisson Korat AV, Sun Q, Rimm EB, Psaty BM, Heckbert SR, Forouhi NG, Wareham NJ, Marklund M, Riserus U, Lind L, Arnlov J, Garg P, Tsai MY, Pankow J, Misialek JR, Gigante B, Leander K, Pester JA, Albert CM, Kavousi M, Ikram A, Voortman T, Schmidt EB, Ninomiya T, Morrow DA, Bayes-Genis A, O'Keefe JH, Ong KL, Wu JHY, Mozaffarian D, Harris WS, Siscovick DS; Fatty Acids and Outcomes Research Consortium (FORCE). Omega-3 Fatty Acid Biomarkers and Incident Atrial Fibrillation. J Am Coll Cardiol. 2023 Jul 25;82(4):336-349. doi: 10.1016/j.jacc.2023.05.024.
PubMed 37468189Gencer B, Djousse L, Al-Ramady OT, Cook NR, Manson JE, Albert CM. Effect of Long-Term Marine ɷ-3 Fatty Acids Supplementation on the Risk of Atrial Fibrillation in Randomized Controlled Trials of Cardiovascular Outcomes: A Systematic Review and Meta-Analysis. Circulation. 2021 Dec 21;144(25):1981-1990. doi: 10.1161/CIRCULATIONAHA.121.055654. Epub 2021 Oct 6.
PubMed 34612056Middeldorp ME, Sandhu RK, Mao J, Gencer B, Danik JS, Moorthy V, Cook NR, Albert CM. Risk Factors for the Development of New-Onset Persistent Atrial Fibrillation: Subanalysis of the VITAL Study. Circ Arrhythm Electrophysiol. 2023 Dec;16(12):651-662. doi: 10.1161/CIRCEP.123.012334. Epub 2023 Nov 29.
PubMed 38018439Siddiqi HK, Vinayagamoorthy M, Gencer B, Ng C, Pester J, Cook NR, Lee IM, Buring J, Manson JE, Albert CM. Sex Differences in Atrial Fibrillation Risk: The VITAL Rhythm Study. JAMA Cardiol. 2022 Oct 1;7(10):1027-1035. doi: 10.1001/jamacardio.2022.2825.
PubMed 36044209Albert CM, Cook NR, Pester J, Moorthy MV, Ridge C, Danik JS, Gencer B, Siddiqi HK, Ng C, Gibson H, Mora S, Buring JE, Manson JE. Effect of Marine Omega-3 Fatty Acid and Vitamin D Supplementation on Incident Atrial Fibrillation: A Randomized Clinical Trial. JAMA. 2021 Mar 16;325(11):1061-1073. doi: 10.1001/jama.2021.1489.
PubMed 33724323Tikkanen JT, Soliman EZ, Pester J, Danik JS, Gomelskya N, Copeland T, Lee IM, Buring JE, Manson JE, Cook NR, Albert CM. A randomized clinical trial of omega-3 fatty acid and vitamin D supplementation on electrocardiographic risk profiles. Sci Rep. 2023 Jul 15;13(1):11454. doi: 10.1038/s41598-023-38344-x.
PubMed 37454148
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Omega-3 Trial (VITAL Rhythm Study)
- ClinicalTrials.gov ID
- NCT02178410
- Acronym / sponsor ID
- 2012P002146
- Conditions
- Cardiovascular Disease
- Keywords
- Atrial Fibrillation, Vitamin D3, Omega-3 fatty acids, Fish oil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25,119 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Cedars-Sinai Medical Center
- Study start
- Oct 2012 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 30 Jun 2014 (estimated)
- 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.
The VITamin D and OmegA-3 TriaL (VITAL) is an ongoing randomized clinical trial of 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in individuals who do not have a prior history of these illnesses. The purpose of this ancillary study is to ascertain and adjudicate atrial fibrillation (AF) outcomes for the primary aim of testing whether omega-3 fatty acid and/or vitamin D supplementation influence atrial fibrillation risk in the general population. We also plan to examine how these agents might impact the development of AF subtypes (persistent versus paroxysmal), intermediate phenotypes for heart rhythm disorders (electrocardiographic parameters), as well as explore effects on arrhythmic death and whether baseline blood levels and/or race modify treatment effects.
Detailed description
Atrial fibrillation and sudden cardiac death assessments, as well as blood analyses, will be conducted on the entire VITAL Study population, and ECG analyses will be limited to the Clinical and Translational Science Center (CTSC) sub-cohort of 1,054 VITAL participants who live near the Boston area and agree to participate in a series of ancillary studies in addition to the main trial.
Investigators will ascertain atrial fibrillation events utilizing self-report of physician diagnoses of atrial fibrillation received on annual questionnaires from study participants supplemented by outpatient and hospital visits for AF identified through Centers for Medicare and Medicaid Services (CMS) data linkage. Investigators will also ascertain additional information regarding atrial fibrillation diagnosis from supplementary questionnaires, and seek consent to review all inpatient and outpatient hospital records pertaining to atrial fibrillation diagnosis and evaluation. Atrial fibrillation events will be confirmed by an endpoint committee composed of cardiologists, which will also make a determination on atrial fibrillation subtype and pattern. Questionnaires that inquire about recurrent atrial fibrillation events, pattern of AF, latest medical record evaluation and treatments for AF will be sent to participants with confirmed atrial fibrillation. Medical records will be requested and reviewed an endpoint committee to determine atrial fibrillation subtype and progression. An intention-to-treat analysis examining the 5-year treatment effects of omega-3 fatty acids and vitamin D on incident atrial fibrillation, as well as subtypes at the time of diagnosis will be performed to address the primary aims. We will repeat these analyses at the end of extended follow-up to assess cumulative and post-treatment effects of omega-3 fatty acids and vitamin D and AF subtypes two years after diagnosis.
Electrocardiograms will be obtained at baseline and again after two years of treatment and follow-up among a sub-cohort of 1,054 patients being enrolled in VITAL at the CTSC. Investigators will utilize these ECG data to evaluate whether treatment with omega-3 fatty acids and vitamin D3 have significant effects on ECG measures. The ECGs will also be utilized to estimate the prevalence of asymptomatic persistent atrial fibrillation in our population not detected by our atrial fibrillation surveillance methods.
Investigators will examine baseline blood samples for participants with confirmed atrial fibrillation for the purpose of exploring whether the effect of vitamin D3 or fish oil supplementation on atrial fibrillation risk varies by the baseline blood levels of these nutrients.
Investigators will also seek additional information necessary to classify deaths as sudden or arrhythmic in origin, and cardiac deaths will be reviewed by an endpoint committee of cardiologists. Once these results have been compiled investigators will explore whether omega-3 fatty acids and/or vitamin D might have an effect on sudden and/or arrhythmic cardiac death.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vitamin D + fish oil | Active comparator | Dietary Supplement: Vitamin D3, Drug: Omega-3 fatty acids (fish oil) |
| Vitamin D + fish oil placebo | Active comparator | Dietary Supplement: Vitamin D3, Dietary Supplement: Fish oil placebo |
| Vitamin D placebo + fish oil | Active comparator | Drug: Omega-3 fatty acids (fish oil), Dietary Supplement: Vitamin D3 placebo |
| Vitamin D placebo + fish oil placebo | Placebo comparator | Dietary Supplement: Fish oil placebo, Dietary Supplement: Vitamin D3 placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- physician diagnosis of atrial fibrillation after randomization
- and/or
- cardiovascular death
Key exclusion criteria (1 listed)
- physician diagnosis of atrial fibrillation prior to randomization
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 |
|---|---|---|
| Vitamin D3Also: cholecalciferolVitamin D3 (cholecalciferol), 2000 IU per day. | Dietary supplement | Vitamin D + fish oil, Vitamin D + fish oil placebo |
| Omega-3 fatty acids (fish oil)Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]). | Drug | Vitamin D + fish oil, Vitamin D placebo + fish oil |
| Fish oil placeboFish oil placebo | Dietary supplement | Vitamin D + fish oil placebo, Vitamin D placebo + fish oil placebo |
| Vitamin D3 placeboVitamin D3 placebo | Dietary supplement | Vitamin D placebo + fish oil, Vitamin D placebo + fish oil placebo |
Primary outcome
Atrial Fibrillation
Time frame: 7 years
To assess whether omega-3 fatty acids (Omacor® 840 mg eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) or vitamin D3 supplementation influences risk of atrial fibrillation in a general population of men and women without prior cardiovascular disease.
2 secondary outcomes
Atrial Fibrillation
Time frame: 7 years
Arrhythmic endpoints
Time frame: 5 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 7 Oct 2025.
- Results publication: PubMed 37468189Qian F, Tintle N, Jensen PN, Lemaitre RN, Imamura F, Feldreich TR, Nomura SO, Guan W, Laguzzi F, Kim E, Virtanen JK, Steur M, Bork CS, Hirakawa Y, O'Donoghue ML, Sala-Vila A, Ardisson Korat AV, Sun Q, Rimm EB, Psaty BM, Heckbert SR, Forouhi NG, Wareham NJ, Marklund M, Riserus U, Lind L, Arnlov J, Garg P, Tsai MY, Pankow J, Misialek JR, Gigante B, Leander K, Pester JA, Albert CM, Kavousi M, Ikram A, Voortman T, Schmidt EB, Ninomiya T, Morrow DA, Bayes-Genis A, O'Keefe JH, Ong KL, Wu JHY, Mozaffarian D, Harris WS, Siscovick DS; Fatty Acids and Outcomes Research Consortium (FORCE). Omega-3 Fatty Acid Biomarkers and Incident Atrial Fibrillation. J Am Coll Cardiol. 2023 Jul 25;82(4):336-349. doi: 10.1016/j.jacc.2023.05.024.
- Results publication: PubMed 34612056Gencer B, Djousse L, Al-Ramady OT, Cook NR, Manson JE, Albert CM. Effect of Long-Term Marine ɷ-3 Fatty Acids Supplementation on the Risk of Atrial Fibrillation in Randomized Controlled Trials of Cardiovascular Outcomes: A Systematic Review and Meta-Analysis. Circulation. 2021 Dec 21;144(25):1981-1990. doi: 10.1161/CIRCULATIONAHA.121.055654. Epub 2021 Oct 6.
- Results publication: PubMed 38018439Middeldorp ME, Sandhu RK, Mao J, Gencer B, Danik JS, Moorthy V, Cook NR, Albert CM. Risk Factors for the Development of New-Onset Persistent Atrial Fibrillation: Subanalysis of the VITAL Study. Circ Arrhythm Electrophysiol. 2023 Dec;16(12):651-662. doi: 10.1161/CIRCEP.123.012334. Epub 2023 Nov 29.
- Results publication: PubMed 36044209Siddiqi HK, Vinayagamoorthy M, Gencer B, Ng C, Pester J, Cook NR, Lee IM, Buring J, Manson JE, Albert CM. Sex Differences in Atrial Fibrillation Risk: The VITAL Rhythm Study. JAMA Cardiol. 2022 Oct 1;7(10):1027-1035. doi: 10.1001/jamacardio.2022.2825.
- Results publication: PubMed 33724323Albert CM, Cook NR, Pester J, Moorthy MV, Ridge C, Danik JS, Gencer B, Siddiqi HK, Ng C, Gibson H, Mora S, Buring JE, Manson JE. Effect of Marine Omega-3 Fatty Acid and Vitamin D Supplementation on Incident Atrial Fibrillation: A Randomized Clinical Trial. JAMA. 2021 Mar 16;325(11):1061-1073. doi: 10.1001/jama.2021.1489.
- Derived from this study: PubMed 37454148Tikkanen JT, Soliman EZ, Pester J, Danik JS, Gomelskya N, Copeland T, Lee IM, Buring JE, Manson JE, Cook NR, Albert CM. A randomized clinical trial of omega-3 fatty acid and vitamin D supplementation on electrocardiographic risk profiles. Sci Rep. 2023 Jul 15;13(1):11454. doi: 10.1038/s41598-023-38344-x.
- Welcome to the VITAL Study websiteLink provided by the sponsor.
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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.
Christine M. Albert, M.D., M.P.H. principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D3 and Omega-3 fatty acids (fish oil) in people with Cardiovascular Disease, run by Brigham and Women's Hospital 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 3 inclusion and 1 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 7 Oct 2025. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Atrial Fibrillation (time frame: 7 years). 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 NCT02178410, which also lists 6 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 7 Oct 2025.