Management of Device Detected AT and Impact of Device Treatment Algorithms on Atrial Fibrillation

Management of Device Detected Atrial Tachyarrhythmia( AT) and Impact of Device Treatment Algorithms on Atrial Fibrillation (AF) in Indian Population

Patrocinadores

Patrocinador principal: Medtronic Cardiac Rhythm and Heart Failure

Fuente Medtronic Cardiac Rhythm and Heart Failure
Resumen breve

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.

Descripción detallada

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.

Estado general Recruiting
Fecha de inicio October 1, 2019
Fecha de Terminación January 2024
Fecha de finalización primaria April 2023
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Time to persistent AF 42months
Resultado secundario
Medida Periodo de tiempo
All-cause death(at the end of 24 months) 42months
Number of Cardiovascular hospitalization 42 Months
Annual rate for all-cause hospitalization 42 months
Measure the AT/AF burden metrics across various time points 42 months
Evaluate number of successful and unsuccessful treated AT/AF episodes out of the detected episodes 42 months
Measure number of delivered therapies per episode 42 months
Evaluate the number of ATP sequences 42 months
Evaluate number of stroke, TIA (Transient ischemic Attack ) or other thromboembolic events 42 months
Percentage of patients treated with anticoagulation therapy 42 months
Measure the LA diameter size 42 months
Number of Pharmacological and electrical cardio versions reported 42 months
Evaluate the biventricular pacing percentage 42 months
Incidence of the composite endpoints like death or Cardiovascular Hospitalizations 42months
Incidence of persistent AF in patients with sick sinus syndrome 42 months
Efficacy of Atrial ATP therapies measured by number of successful termination of AF events 42 months
Inscripción 758
Condición
Intervención

Tipo de intervención: Other

Nombre de intervención: Treatment arm

Descripción: 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

Etiqueta de grupo de brazo: Treatment arm

Otro nombre: programming changes

Elegibilidad

Criterios:

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.

- Age > 60 years;

- Stroke/TIA (Transient ischemic Attack);

- Diabetes;

- High Blood Pressure;

- Coronary artery disease;

- 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.

Exclusion criteria:

Patients are not eligible to be enrolled in the study if any of the following criteria is met:

1. 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;

2. Subject is in permanent AF or persistent AF at the baseline visit:

1. 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:

2. 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)

3. Participation in other studies which could potentially conflict with this study;

4. 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.

Género: All

Edad mínima: 18 Years

Edad máxima: 100 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Shantanu Sarkar, PhD Study Chair Medtronic, PLC
Contacto general

Apellido: Sindhu A John, PG

Teléfono: +912233074700

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Copia de seguridad de contactos: Investigador:
Sir Ganga Ram Hospital | New Delhi, Delhi, 110060, India Not yet recruiting JPS Sawhney, MD +919810059773 [email protected] JPS Sawhney, MD Principal Investigator
Fortis Escorts Heart Institute | New Delhi, Delhi, India Not yet recruiting Anil Saxena, MD Anil Saxena, MD Principal Investigator
Care Institute of medical sciences and research | Ahmedabad, Gujarat, India Recruiting Ajay Naik, MD Ajay Naik, MD Principal Investigator
Eternal Heart Care center and Research | Jaipur, Rajasthan, India Not yet recruiting Jitender Makkar, MD Jitender Makkar, MD Principal Investigator
Apollo Hospital | Chennai, Tamil Nadu, India Not yet recruiting A.M Karthigesan, MD A.M karthigesan, MD Principal Investigator
CARE hospital | Hyderabad, Telengana, India Not yet recruiting Calambur Narasimhan, MD Calambur Narasimhan Principal Investigator
Ubicacion Paises

India

Fecha de verificación

November 2019

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Control arm

Tipo: No Intervention

Descripción: 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)

Etiqueta: Treatment arm

Tipo: Active Comparator

Descripción: 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)

Acrónimo MANDATE-AF
Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Single (Participant)

Descripción de enmascaramiento: 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 )

Fuente: ClinicalTrials.gov