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)™, 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
79
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
Care Institute of medical sciences and research
Ahmedabad, Gujarat, India
Apollo Hospital , Bannerghatta
Bangalore, Karnataka, India
Apollo BGS Hospital
Mysore, Karnataka, India
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.
Time frame: up to 18 months
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.
Time frame: 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.'
Time frame: 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
Time frame: 18 months
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Aster Medicity
Kochi, Kerala, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 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
...and 1 more locations
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.
Time frame: 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.
Time frame: 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.
Time frame: 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 .
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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;
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 42 months