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Sponsors decision to terminate the study based on the current Covid situation which is preventing completion of study milestone.
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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.
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)â„¢, 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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment arm | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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.
Exclusion criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Shantanu Sarkar, PhD | Medtronic, PLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Care Institute of medical sciences and research | Ahmedabad | Gujarat | India | |||
| Apollo Hospital , Bannerghatta |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12401529 | Background | 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. | |
| 11343485 | Result | Go 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. |
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The study was based on Standard of Care practice and all of the pts were previously implanted with the device, so they were enrolled as long as they met the inclusion criteria and Pt was willing to consent . A total of 79 subjects were enrolled, of which 75 were eligible and randomized.
The study was multicentric and in a hospital setting, patients were selected based on retrospective data . The study recruitment lasted from 1 Oct 2019 till 30 May 2021 even though the LPE was 5 Feb 2021. The recruitment period ended earlier than initially planned (18 months expected) due to the decision to early terminate the study due to Covid impact.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Arm | 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) |
| FG001 | Treatment Arm | 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) Treatment arm: 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Arm | 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) |
| BG001 | Treatment Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The study execution was severely impacted by COVID-19 pandemic. Thus, the decision was taken to terminate the study in August 2021. The median clinical follow-up duration for subject was 14.9 months (over at least 24 months expected), but 33.1% of scheduled visits were missed. The median device follow-up duration for subjects was 7.4 months, 2 out of 75 patients had no device interrogations and 16 only had a baseline device interrogation.Persistent AF occurrence obtained using results from KM. | Posted | Number | 95% Confidence Interval | percentage probability | up to 18 months |
|
The adverse events were collected up to 18 months after the index procedure. A total of three adverse events (AEs) (two in the interventional arm and one in the control arm) occurred in three subjects. Of the three, only one AE resulted in the hospitalization of the subject., which was not classified as HF-related, AF-related, or other CV-related
As this is a post market interventional study, we will collect all cardiovascular-related Adverse Event, device-related AE and all SAE.Investigator shall report all SAEs, SADEs and USADEs to the Ethics Committee, monitor and Sponsor promptly of their occurrence.
For reported deaths, the investigator shall supply any additional information (e.g., autopsy report ).It is recommended for investigator to report all SAEs, SADE, USADEs to EC within 7 working days .
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Arm | 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | ISO 14155:2011 3.36 | Systematic Assessment |
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The study execution was severely impacted by the COVID-19 pandemic. Due to poor enrollment rates, low follow-up compliance (33.1% of scheduled visits missed), changes to the operating unit product portfolio, very few Reactive ATP enabled devices locally available, and changes to the local evidence strategy, the decision was taken to terminate the study in August 2021, with a total of 75 subjects enrolled (out of 758 planned). Data was primarily analyzed using descriptive statistics.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Vinay Rajan, Clinical Research Manager | India Medtronic Pvt Ltd | +91-2248810700 | vinay.rajan@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 26, 2019 | Oct 5, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 27, 2021 | Apr 23, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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The patient is unaware of which type of programming changes have been made ( whether it is the reduced sequence programming or the standard Minerva setting )
|
|
| 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.' | 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 | 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. | 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. | 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. | 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 . | 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 | 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. | 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 | 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. | 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 | 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; | 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) | 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. | 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. | 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. | 42 months |
| Bangalore |
| Karnataka |
| India |
| Apollo BGS Hospital | Mysore | Karnataka | India |
| Aster Medicity | Kochi | Kerala | India |
| Sir Ganga Ram Hospital | New Delhi | National Capital Territory of Delhi | 110060 | India |
| Fortis Escorts Heart Institute | New Delhi | National Capital Territory of Delhi | India |
| Apollo Hospital | Bhubaneswar | Odisha | India |
| Fortis Escort Hospital | Mohali | Punjab | India |
| Eternal Heart Care center and Research | Jaipur | Rajasthan | India |
| Apollo Hospital | Chennai | Tamil Nadu | India |
| AIG hospital | Hyderabad | Telangana | India |
| 20876603 | Result | Camm 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. |
| 9809895 | Result | Kannel 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. |
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) Treatment arm: 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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Weight | Median | Inter-Quartile Range | kg |
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| Height | Median | Inter-Quartile Range | cm |
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| BMI | Median | Inter-Quartile Range | kg/m2 |
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| Systolic BP | Median | Inter-Quartile Range | mmHg |
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| Diastolic BP | Median | Inter-Quartile Range | mmHg |
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| Hearth Rate | Median | Inter-Quartile Range | beats/min |
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| cha2ds2-vasc score | This score is used for estimating the risk of stroke in patients with atrial fibrillation (AF). A high score corresponds to a greater risk of stroke, while a low score corresponds to a lower risk of stroke.The score is obtained by summing the points relative to each condition presented by the patient. If any of the condition is missing, for example the information about the gender is missing, then the score will be considered as missing. Reference: doi:10.1093/eurheartj/ehq278 | Count of Participants | Participants |
|
| OG000 |
| Control Arm |
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) |
| OG001 | Treatment Arm | 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) Treatment arm: 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 |
|
|
| Secondary | 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. | Seven-hundred and fifty-eight (758) subjects were planned to be enrolled, randomized in a 1:1 fashion to either the interventional or control arms. One subject passed away during the study period due to a myocardial infarction 16.5 months after device implant and 3.1 months after randomization. | Posted | Number | 95% Confidence Interval | percentage probability | up to 18 months |
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| Secondary | 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.' | A large number of scheduled visits (33.1%) and data were missed between both arms | Posted | Number | 95% Confidence Interval | percentage of participants | 18 Months |
|
|
|
| Secondary | 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 | Only one hospitalization event was reported. This hospitalization was not classified as HF-related, AF-related, or other CV-related. | Posted | Number | 95% Confidence Interval | event/year | 18 months |
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|
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| Secondary | 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. | A large number of scheduled visits (33.1%) and data were missed between both arms | Posted | Number | 95% Confidence Interval | percentage probability | up to 18 months |
|
|
|
| Secondary | 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. | A large number of scheduled visits (33.1%) and data were missed between both arms | Posted | Number | 95% Confidence Interval | percentage probability | up to 18 months |
|
|
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| Secondary | 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. | A large number of scheduled visits (33.1%) and data were missed between both arms | Posted | Number | 95% Confidence Interval | percentage probability | up to 18 months |
|
|
|
| Secondary | 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 . | A large number of scheduled visits (33.1%) and data were missed between both arms. | Posted | Median | Inter-Quartile Range | events | 18 months |
|
|
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| Secondary | 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 | A large number of scheduled visits (33.1%) and data were missed between both arms | Posted | Median | Inter-Quartile Range | Number of ATP Therapies delivered per AF | 18 months |
|
|
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| Secondary | 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. | A large number of scheduled visits (33.1%) and data were missed between both arms | Posted | Median | Inter-Quartile Range | therapies | 18 months |
|
|
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| Secondary | 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 | A large number of scheduled visits (33.1%) and data were missed between both arms | Posted | Number | 95% Confidence Interval | events | 18 months |
|
|
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| Secondary | 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. | A large number of scheduled visits (33.1%) and data were missed between both arms. antithrombotic agents. | Posted | Count of Participants | Participants | 18 months |
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| Secondary | 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 | A large number of scheduled visits (33.1%) and data were missed between both arms | Posted | Median | Inter-Quartile Range | mm | up to 18 months |
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| Secondary | 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; | A large number of scheduled visits (33.1%) and data were missed between both arms | Posted | Number | 95% Confidence Interval | events | 18 months |
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| Secondary | 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) | Of the 75 enrolled patients, only 15 had CRT-D or CRT-P device implanted, of which 10 were assigned to the interventional arm and 5 to the control arm. | Posted | Median | Inter-Quartile Range | percentage of ventricular pacing | 18 months |
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| Secondary | 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. | Not Posted | 42months | Participants |
| Secondary | 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. | Not Posted | 42 months | Participants |
| Secondary | 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. | Not Posted | 42 months | Participants |
| 0 |
| 38 |
| 1 |
| 38 |
| 0 |
| 38 |
| EG001 | Treatment Arm | 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) Treatment arm: 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 | 1 | 37 | 2 | 37 | 0 | 37 |
| lead explantation and IPG repositioning | Product Issues | ISO 14155:2011 3.36 | Systematic Assessment | subject underwent a system modification: their implanted IPG was repositioned, and the RV lead was explanted and replaced |
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| General disorders | ISO 14155:2011 3.36 | Systematic Assessment | event led to the hospitalization of the subject. it was determined that this event was not HF, AF or other CV related. |
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