Cardiovascular DiseasesMANDATE-AFNCT04172883
Management of Device Detected AT and Impact of Device Treatment Algorithms on Atrial Fibrillation
A study testing Treatment arm in people with Cardiovascular Diseases, run by Medtronic Cardiac Rhythm and Heart Failure at 11 sites in India.
Trial summary
The MANDATE-AF study was designed to address evidence needs in India for device-based management of AF using AT/AF (Atrial Tachycardia/Atrial fibrillation) diagnostic features and therapies such as Reactive Atrial anti tachycardia Pacing (rATP) within Medtronic Cardiac Implantable Electronic Devices (CIED)and its… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Treatment arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 11 sitesIndia
- Study dates
- 1 Oct 2019to 28 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 Subject is implanted with a Medtronic cardiac implantable device with an atrial lead equipped with atrial ATP therapies (rATP) enabled no longer than 18 months and at the minimum 6 weeks has passed since the implant; 2. Age > 55 years; 3. Subject provides informed consent; 4. Subject is willing and able to comply with the study procedures; 5. Subject has documented history of atrial fibrillation or atrial flutter, or one or more of the risk factors for developing AF as per AHA/HRS (American heart Association/Heart rhythm Society) guidelines.
- Age > 60 years;
- Stroke/TIA (Transient ischemic Attack);
- Diabetes;
- High Blood Pressure;
- Coronary artery disease;
Show all 18Show fewer
- Cardiomyopathy;
- Pericardial inflammation;
- Prior heart attacks;
- Congestive heart failure;
- Structural heart disease (valve problems or congenital defects);
- Prior open-heart surgery;
- Untreated atrial flutter (another type of abnormal heart rhythm);
- Thyroid disease;
- Chronic lung disease;
- Sleep apnea;
- Excessive alcohol use;
- Serious illness or infection.
Who cannot join
- Patients are not eligible to be enrolled in the study if any of the following criteria is met:
- Subject has been implanted with a Medtronic cardiac implantable device with an atrial lead equipped with atrial ATP therapies (rATP) enabled for more than 18 months;
- Subject is in permanent AF or persistent AF at the baseline visit:
- The definition of permanent AF will be based on the physicians' decision that nothing further can be done to cardiovert the patient or, in historical cases, the investigators will refer to the Cardiac Compass reports:
- The definition of persistent AF at baseline will refer to the Cardiac Compass reports (>7 consecutive days in AF with the last day being the day of enrollment)
- Participation in other studies which could potentially conflict with this study;
- Legal incapacity or evidence that a subject cannot understand the purpose and risks of the study or inability to comply fully with study procedures and follow up.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
India11 sites
Care Institute of medical sciences and research
Ahmedabad, Gujarat
Apollo Hospital , Bannerghatta
Bangalore, Karnataka
Apollo Hospital
Bhubaneswar, Odisha
Apollo Hospital
Chennai, Tamil Nadu
AIG hospital
Hyderabad, Telangana
Eternal Heart Care center and Research
Jaipur, Rajasthan
Aster Medicity
Kochi, Kerala
Fortis Escort Hospital
Mohali, Punjab
Apollo BGS Hospital
Mysore, Karnataka
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060
Fortis Escorts Heart Institute
New Delhi, National Capital Territory of Delhi
About this study
Official title: Management of Device Detected Atrial Tachyarrhythmia( AT) and Impact of Device Treatment Algorithms on Atrial Fibrillation (AF) in Indian Population
The MANDATE-AF study was designed to address evidence needs in India for device-based management of AF using AT/AF (Atrial Tachycardia/Atrial fibrillation) diagnostic features and therapies such as Reactive Atrial anti tachycardia Pacing (rATP) within Medtronic Cardiac Implantable Electronic Devices (CIED)and its impact on the time to persistent AF and progression of AT/AF.
Read the detailed description
New generation Cardiac Implantable Electronic devices (CIED's)such as Pacemakers, Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT) has diagnostic and treatment delivery features which helps in slowing the progression of Atrial Fibrillation. A Study conducted in Europe, called the MINERVA Trial, showed the efficacy of a feature within Medtronic CIED's called (rATP)™, in the termination of abnormal rhythms by pacing stimuli, and clinical benefit in reducing incidence of Atrial Fibrillation. However, there is dearth of local evidence of this within the Indian population and also a need to show that turning on rATP does not compromise on battery depletion.
The MANDATE-AF study is a prospective , Interventional , Randomized, single blind study aiming to show that a reduced sequence programming of this rATP therapy ,can improve device battery longevity and is as effective as the Minerva trial ATP programming when it comes to showing its impact on time to persistent AF and on the progression of AT/AF within the Indian population.
The study analyses patients implanted with a Medtronic cardiac implantable device with an atrial lead and equipped with atrial ATP therapies.
The patients will be randomized into two groups:
- an interventional arm including patients with a conservative atrial ATP therapies programming setting
- a control, arm including patients with the same atrial ATP therapies programming setting adopted in the Minerva Trial
Cardiovascular events will be collected prospectively for at least 24 months after enrollment. Physicians will be recommended to schedule in clinic follow-up visits every 6 months and remote follow-up visits every 3 months in between. Every patient will be followed for at least 24 months, until the last patient enrolled exits the study.
- Conditions
- Cardiovascular Diseases
- Being tested
- Treatment arm
- Keywords
- Reactive ATP, device based Management of Atrial fibrilation, AF Management
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment armOther
Also called programming changes
All pts are implanted with rATP enabled devices prior to the study start , the only intervention in both arms is switching on rATP and in the treatment arm programming changes done to optimize the rATP sequence delivery of therapy and prevent the patient from going into permanent or persistent AF
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the standard device setting or MINERVA setting ( control arm) |
| Treatment arm | Active comparator | The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the reduced sequence programming ( treatment arm) Receives: Other: Treatment arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of 'Persistent AF' Over Time
Probability of participants to encounter 'Persistant AF" was analyzed over time. This information is obtained using Kaplan-Meier method. The occurrence of Persistant AF has been studied over time by using Kaplan-Meier technique. Probabilities and their 95% confidence intervals have been obtained at baseline, 6 months, 12 months and 18 months. We are studying the occurrence of Persistant AF based on results obtained from the Kaplan-Meier method.
Measured: up to 18 months
Secondary outcomes (17)
Incidence of All-cause Death Over Time
Probability of participants to encounter 'All-cause death was analyzed over time. This information is obtained using Kaplan-Meier method. The occurrence of All-cause death has been studied over time by using Kaplan-Meier technique. Probabilities and their 95% confidence intervals have been obtained at baseline, 6 months, 12 months and 18 months. We are studying the occurrence of All-cause death based on results obtained from the Kaplan-Meier method.
Measured: up to 18 months
Cardiovascular Hospitalization
Compare the two atrial ATP Programming arms in terms of clinical endpoints such as cardiovascular hospitalizations (due to Heart Failure (HF), AF or other), as measured by the time to first event and annual rate of such events. No CV related hospitalization events were observed.
This information is obtained using the Kaplan-Meier method. The incidence of CV hospitalization has been studied using the Kaplan-Meier technique. Incidence rates and their 95% confidence intervals have been obtained at baseline, 6 months, 12 months and 18 months.'
Measured: 18 Months
Annual Rate for All-cause Hospitalization
Compare the two atrial ATP Programming arms in terms of clinical endpoints such as all cause hospitalizations and its annual rate on the study
Measured: 18 months
Incidence of AT/AF Burden ≥ 1day Overtime
Probability of participants to encounter AT/AF Burden ≥ 1day was analyzed over time. This information is obtained using Kaplan-Meier method. The occurrence of AT/AF Burden ≥ 1day has been studied over time by using Kaplan-Meier technique. Probabilities and their 95% confidence intervals have been obtained at baseline, 6 months, 12 months and 18 months. We are studying the occurrence of AT/AF Burden ≥ 1day based on results obtained from the Kaplan-Meier method.
Measured: up to 18 months
Incidence of AT/AF Burden ≥ 30 Days Overtime
Probability of participants to encounter AT/AF Burden ≥ 30 days was analyzed over time. This information is obtained using Kaplan-Meier method. The occurrence of 'AT/AF Burden ≥ 30 days has been studied over time by using Kaplan-Meier technique. Probabilities and their 95% confidence intervals have been obtained at baseline, 6 months, 12 months and 18 months. We are studying the occurrence of AT/AF Burden ≥ 30 days based on results obtained from the Kaplan-Meier method.
Measured: up to 18 months
Incidence of AT/AF Burden ≥ 2 Days Overtime
Probability of participants to encounter AT/AF Burden ≥ 2 days was analyzed over time. This information is obtained using Kaplan-Meier method. The occurrence of AT/AF Burden ≥ 2 days has been studied over time by using Kaplan-Meier technique. Probabilities and their 95% confidence intervals have been obtained at baseline, 6 months, 12 months and 18 months. We are studying the occurrence of AT/AF Burden ≥ 2 days based on results obtained from the Kaplan-Meier method.
Measured: up to 18 months
Evaluate Number of Successful and Unsuccessful Treated AT/AF Episodes Out of the Detected Episodes
Compare the two atrial ATP Programming arms in terms of clinical endpoints to assess number of successful and unsuccessful treated AT/AF episodes out of detected episodes by the device .
Measured: 18 months
Measure Number of Delivered Therapies Per Episode
Compare the two ATP programming arms in terms of clinical endpoints to measure the average number of ATP sequences delivered per patient on each arm
Measured: 18 months
Evaluate the Number of ATP Sequences
Compare the two ATP programming arms in terms of clinical endpoints to measure the number of ATP sequences delivered on each arm.
Measured: 18 months
Evaluate Number of Stroke, TIA (Transient Ischemic Attack ) or Other Thromboembolic Events
compare the two atrial ATP Programming arms in terms of clinical endpoints to calculate number of stroke, TIA or other thromboembolic events reported on the study across both arms
Measured: 18 months
Percentage of Patients Treated With Anticoagulation Therapy
Compare the two ATP programming arms in terms of clinical endpoints to evaluate the percentage of patients treated with anticoagulation therapy according to AF management guideline.
Measured: 18 months
Measure the Left Atrial Diameter Size
Compare the two ATP programming arms in terms of clinical endpoints to evaluate the Left Atrial diameter (if available) as measured through an Echocardiogram
Measured: up to 18 months
Number of Pharmacological and Electrical Cardio Versions Reported
Compare the two ATP programming arms in terms of clinical endpoints such as number of electrical or pharmacological cardio-versions measured in terms of time to first event and its annual rate on the study;
Measured: 18 months
Evaluate the Biventricular Pacing Percentage (Average)
Compare the two ATP programming arms in terms of clinical endpoints such as biventricular pacing percentage (in cardiac resynchronization therapy defibrillator (CRT-D) / cardiac resynchronization therapy-Pacemaker (CRT-P) patients)
Measured: 18 months
Incidence of the Composite Endpoints Like Death or Cardiovascular Hospitalizations
A cumulative endpoint which includes number of deaths, cardiovascular hospitalizations, stroke, TIA or other thromboembolic events.
Measured: 42months
Incidence of Persistent AF in Patients With Sick Sinus Syndrome
To evaluate the incidence of persistent AF in patients with sick sinus syndrome as compared to the one found in the Minerva trial, and characterize the difference between the European and Indian populations. The unit of measure will be number of pts that had persistent AF on the study.
Measured: 42 months
Efficacy of Atrial ATP Therapies Measured by Number of Successful Termination of AF Events
To evaluate the efficacy of atrial ATP therapies as a function of the device type (Pacemakers(IPG),Cardiac defibrillators (ICD),Cardiac resynchronization Therapy (CRT-D, CRT-P), and population characteristics (baseline characteristics, implant indications) in optimizing therapy and evaluating the successful termination of AF events, preventing pts from going into persistent or permanent AF, as measured by no of ATP's delivered by device.
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Oct 2019
- Primary completion15 Jul 2021
- Study completion28 Jul 2021
Why it stopped: Sponsors decision to terminate the study based on the current Covid situation which is preventing completion of study milestone.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shantanu Sarkar, PhD, Study chair, Medtronic, PLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172883
- Sponsor's protocol ID
- MDT18039
- Acronym
- MANDATE-AF
- Status last verified
- Feb 2026
- First submitted
- 28 May 2019
- Last updated
- 27 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stewart S, Hart CL, Hole DJ, McMurray JJ. A population-based study of the long-term risks associated with atrial fibrillation: 20-year follow-up of the Renfrew/Paisley study. Am J Med. 2002 Oct 1;113(5):359-64. doi: 10.1016/s0002-9343(02)01236-6.
PubMed 12401529Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370.
PubMed 11343485Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH; ESC Committee for Practice Guidelines. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Europace. 2010 Oct;12(10):1360-420. doi: 10.1093/europace/euq350. No abstract available.
PubMed 20876603Kannel WB, Wolf PA, Benjamin EJ, Levy D. Prevalence, incidence, prognosis, and predisposing conditions for atrial fibrillation: population-based estimates. Am J Cardiol. 1998 Oct 16;82(8A):2N-9N. doi: 10.1016/s0002-9149(98)00583-9.
PubMed 9809895
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Device Detected Atrial Tachyarrhythmia( AT) and Impact of Device Treatment Algorithms on Atrial Fibrillation (AF) in Indian Population
- ClinicalTrials.gov ID
- NCT04172883
- Acronym / sponsor ID
- MANDATE-AF / MDT18039
- Conditions
- Cardiovascular Diseases
- Keywords
- Reactive ATP, device based Management of Atrial fibrilation, AF Management
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsors decision to terminate the study based on the current Covid situation which is preventing completion of study milestone.
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Posted 27 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The MANDATE-AF study was designed to address evidence needs in India for device-based management of AF using AT/AF (Atrial Tachycardia/Atrial fibrillation) diagnostic features and therapies such as Reactive Atrial anti tachycardia Pacing (rATP) within Medtronic Cardiac Implantable Electronic Devices (CIED)and its impact on the time to persistent AF and progression of AT/AF.
Detailed description
New generation Cardiac Implantable Electronic devices (CIED's)such as Pacemakers, Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT) has diagnostic and treatment delivery features which helps in slowing the progression of Atrial Fibrillation. A Study conducted in Europe, called the MINERVA Trial, showed the efficacy of a feature within Medtronic CIED's called (rATP)™, in the termination of abnormal rhythms by pacing stimuli, and clinical benefit in reducing incidence of Atrial Fibrillation. However, there is dearth of local evidence of this within the Indian population and also a need to show that turning on rATP does not compromise on battery depletion.
The MANDATE-AF study is a prospective , Interventional , Randomized, single blind study aiming to show that a reduced sequence programming of this rATP therapy ,can improve device battery longevity and is as effective as the Minerva trial ATP programming when it comes to showing its impact on time to persistent AF and on the progression of AT/AF within the Indian population.
The study analyses patients implanted with a Medtronic cardiac implantable device with an atrial lead and equipped with atrial ATP therapies.
The patients will be randomized into two groups:
- an interventional arm including patients with a conservative atrial ATP therapies programming setting
- a control, arm including patients with the same atrial ATP therapies programming setting adopted in the Minerva Trial
Cardiovascular events will be collected prospectively for at least 24 months after enrollment. Physicians will be recommended to schedule in clinic follow-up visits every 6 months and remote follow-up visits every 3 months in between. Every patient will be followed for at least 24 months, until the last patient enrolled exits the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the standard device setting or MINERVA setting ( control arm) |
| Treatment arm | Active comparator | Other: Treatment armThe devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the reduced sequence programming ( treatment arm) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 1 Subject is implanted with a Medtronic cardiac implantable device with an atrial lead equipped with atrial ATP therapies (rATP) enabled no longer than 18 months and at the minimum 6 weeks has passed since the implant; 2. Age > 55 years; 3. Subject provides informed consent; 4. Subject is willing and able to comply with the study procedures; 5. Subject has documented history of atrial fibrillation or atrial flutter, or one or more of the risk factors for developing AF as per AHA/HRS (American heart Association/Heart rhythm Society) guidelines.
- Age > 60 years;
- Stroke/TIA (Transient ischemic Attack);
- Diabetes;
- High Blood Pressure;
Key exclusion criteria (7 listed)
- Patients are not eligible to be enrolled in the study if any of the following criteria is met:
- Subject has been implanted with a Medtronic cardiac implantable device with an atrial lead equipped with atrial ATP therapies (rATP) enabled for more than 18 months;
- Subject is in permanent AF or persistent AF at the baseline visit:
- Participation in other studies which could potentially conflict with this study;
- Legal incapacity or evidence that a subject cannot understand the purpose and risks of the study or inability to comply fully with study procedures and follow up.
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 |
|---|---|---|
| Treatment armAlso: programming changesAll pts are implanted with rATP enabled devices prior to the study start , the only intervention in both arms is switching on rATP and in the treatment arm programming changes done to optimize the rATP sequence delivery of therapy and prevent the patient from going into permanent or persistent AF | Other | Treatment arm |
Primary outcome
Incidence of 'Persistent AF' Over Time
Time frame: up to 18 months
Probability of participants to encounter 'Persistant AF" was analyzed over time. This information is obtained using Kaplan-Meier method. The occurrence of Persistant AF has been studied over time by using Kaplan-Meier technique. Probabilities and their 95% confidence intervals have been obtained at baseline, 6 months, 12 months and 18 months. We are studying the occurrence of Persistant AF based on results obtained from the Kaplan-Meier method.
17 secondary outcomes
Incidence of All-cause Death Over Time
Time frame: up to 18 months
Cardiovascular Hospitalization
Time frame: 18 Months
Annual Rate for All-cause Hospitalization
Time frame: 18 months
Incidence of AT/AF Burden ≥ 1day Overtime
Time frame: up to 18 months
Incidence of AT/AF Burden ≥ 30 Days Overtime
Time frame: up to 18 months
Incidence of AT/AF Burden ≥ 2 Days Overtime
Time frame: up to 18 months
Evaluate Number of Successful and Unsuccessful Treated AT/AF Episodes Out of the Detected Episodes
Time frame: 18 months
Measure Number of Delivered Therapies Per Episode
Time frame: 18 months
Evaluate the Number of ATP Sequences
Time frame: 18 months
Evaluate Number of Stroke, TIA (Transient Ischemic Attack ) or Other Thromboembolic Events
Time frame: 18 months
Percentage of Patients Treated With Anticoagulation Therapy
Time frame: 18 months
Measure the Left Atrial Diameter Size
Time frame: up to 18 months
Number of Pharmacological and Electrical Cardio Versions Reported
Time frame: 18 months
Evaluate the Biventricular Pacing Percentage (Average)
Time frame: 18 months
Incidence of the Composite Endpoints Like Death or Cardiovascular Hospitalizations
Time frame: 42months
Incidence of Persistent AF in Patients With Sick Sinus Syndrome
Time frame: 42 months
Efficacy of Atrial ATP Therapies Measured by Number of Successful Termination of AF Events
Time frame: 42 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12401529Stewart S, Hart CL, Hole DJ, McMurray JJ. A population-based study of the long-term risks associated with atrial fibrillation: 20-year follow-up of the Renfrew/Paisley study. Am J Med. 2002 Oct 1;113(5):359-64. doi: 10.1016/s0002-9343(02)01236-6.
- Results publication: PubMed 11343485Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370.
- Results publication: PubMed 20876603Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH; ESC Committee for Practice Guidelines. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Europace. 2010 Oct;12(10):1360-420. doi: 10.1093/europace/euq350. No abstract available.
- Results publication: PubMed 9809895Kannel WB, Wolf PA, Benjamin EJ, Levy D. Prevalence, incidence, prognosis, and predisposing conditions for atrial fibrillation: population-based estimates. Am J Cardiol. 1998 Oct 16;82(8A):2N-9N. doi: 10.1016/s0002-9149(98)00583-9.
- Individual participant dataSharing planned: No
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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.
Shantanu Sarkar, PhD study chair
Medtronic, PLC
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment arm in people with Cardiovascular Diseases, run by Medtronic Cardiac Rhythm and Heart Failure at 11 sites in India.
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 18 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: stopped early, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in India. 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?
Yes. Results are posted in the registry (first posted 27 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of 'Persistent AF' Over Time (time frame: up to 18 months). 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 NCT04172883, which also lists 4 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 27 Feb 2026.