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Management of Device Detected AT and Impact of Device Treatment Algorithms on Atrial Fibrillation (MANDATE-AF)

Primary Purpose

Cardiovascular Diseases

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Treatment arm
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases focused on measuring Reactive ATP, device based Management of Atrial fibrilation, AF Management

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sir Ganga Ram Hospital
  • Fortis Escorts Heart Institute
  • Care Institute of medical sciences and research
  • Apollo Hospital , Bannerghatta
  • Apollo BGS Hospital
  • Aster Medicity
  • Apollo Hospital
  • Fortis Escort Hospital
  • Eternal Heart Care center and Research
  • Apollo Hospital
  • AIG hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control arm

Treatment arm

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Time to persistent AF
time to persistent AF (defined as more than 7 continuous days of AF) or permanent AF

Secondary Outcome Measures

All-cause death(at the end of 24 months)
Compare the two atrial ATP Programming arms in terms of clinical endpoints such as deaths that occur on the study
Number of 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
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
Measure the AT/AF burden metrics across various time points
Compare the two atrial ATP Programming arms in terms of clinical endpoints to evaluate the AT/AF burden metrics (amount of time each AF event lasts) as measured in terms of time to first event (daily burden ≥1 day, ≥2 days, ≥30 days) or the ratio between time in AT/AF and the observation period (the duration the patient is on the study)
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 .
Measure number of delivered therapies per episode
compare the two atrial ATP Programming arms in terms of clinical endpoints to measure the number of therapies delivered per episode to mitigate the AT/AF event.
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.
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
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
Measure the LA diameter size
Compare the two ATP programming arms in terms of clinical endpoints to evaluate the LA diameter (if available) as measured through an Echocardiogram
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;
Evaluate the biventricular pacing percentage
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)
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.
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.
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.

Full Information

First Posted
May 28, 2019
Last Updated
September 21, 2021
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT04172883
Brief Title
Management of Device Detected AT and Impact of Device Treatment Algorithms on Atrial Fibrillation
Acronym
MANDATE-AF
Official Title
Management of Device Detected Atrial Tachyarrhythmia( AT) and Impact of Device Treatment Algorithms on Atrial Fibrillation (AF) in Indian Population
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
July 15, 2021 (Actual)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases
Keywords
Reactive ATP, device based Management of Atrial fibrilation, AF Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
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 )
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
No Intervention
Arm Description
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)
Arm Title
Treatment arm
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Treatment arm
Other Intervention Name(s)
programming changes
Intervention Description
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
Primary Outcome Measure Information:
Title
Time to persistent AF
Description
time to persistent AF (defined as more than 7 continuous days of AF) or permanent AF
Time Frame
42months
Secondary Outcome Measure Information:
Title
All-cause death(at the end of 24 months)
Description
Compare the two atrial ATP Programming arms in terms of clinical endpoints such as deaths that occur on the study
Time Frame
42months
Title
Number of Cardiovascular hospitalization
Description
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
Time Frame
42 Months
Title
Annual rate for all-cause hospitalization
Description
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
42 months
Title
Measure the AT/AF burden metrics across various time points
Description
Compare the two atrial ATP Programming arms in terms of clinical endpoints to evaluate the AT/AF burden metrics (amount of time each AF event lasts) as measured in terms of time to first event (daily burden ≥1 day, ≥2 days, ≥30 days) or the ratio between time in AT/AF and the observation period (the duration the patient is on the study)
Time Frame
42 months
Title
Evaluate number of successful and unsuccessful treated AT/AF episodes out of the detected episodes
Description
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
42 months
Title
Measure number of delivered therapies per episode
Description
compare the two atrial ATP Programming arms in terms of clinical endpoints to measure the number of therapies delivered per episode to mitigate the AT/AF event.
Time Frame
42 months
Title
Evaluate the number of ATP sequences
Description
Compare the two ATP programming arms in terms of clinical endpoints to measure the number of ATP sequences delivered on each arm.
Time Frame
42 months
Title
Evaluate number of stroke, TIA (Transient ischemic Attack ) or other thromboembolic events
Description
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
42 months
Title
Percentage of patients treated with anticoagulation therapy
Description
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
42 months
Title
Measure the LA diameter size
Description
Compare the two ATP programming arms in terms of clinical endpoints to evaluate the LA diameter (if available) as measured through an Echocardiogram
Time Frame
42 months
Title
Number of Pharmacological and electrical cardio versions reported
Description
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
42 months
Title
Evaluate the biventricular pacing percentage
Description
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
42 months
Title
Incidence of the composite endpoints like death or Cardiovascular Hospitalizations
Description
A cumulative endpoint which includes number of deaths, cardiovascular hospitalizations, stroke, TIA or other thromboembolic events.
Time Frame
42months
Title
Incidence of persistent AF in patients with sick sinus syndrome
Description
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
Title
Efficacy of Atrial ATP therapies measured by number of successful termination of AF events
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shantanu Sarkar, PhD
Organizational Affiliation
Medtronic, PLC
Official's Role
Study Chair
Facility Information:
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Fortis Escorts Heart Institute
City
New Delhi
State/Province
Delhi
Country
India
Facility Name
Care Institute of medical sciences and research
City
Ahmedabad
State/Province
Gujarat
Country
India
Facility Name
Apollo Hospital , Bannerghatta
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
Apollo BGS Hospital
City
Mysore
State/Province
Karnataka
Country
India
Facility Name
Aster Medicity
City
Kochi
State/Province
Kerala
Country
India
Facility Name
Apollo Hospital
City
Bhubaneshwar
State/Province
Odisha
Country
India
Facility Name
Fortis Escort Hospital
City
Mohali
State/Province
Punjab
Country
India
Facility Name
Eternal Heart Care center and Research
City
Jaipur
State/Province
Rajasthan
Country
India
Facility Name
Apollo Hospital
City
Chennai
State/Province
Tamil Nadu
Country
India
Facility Name
AIG hospital
City
Hyderabad
State/Province
Telengana
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12401529
Citation
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.
Results Reference
background
PubMed Identifier
11343485
Citation
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.
Results Reference
result
PubMed Identifier
20876603
Citation
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. Erratum In: Europace. 2011 Jul;13(7):1058. Dosage error in article text.
Results Reference
result
PubMed Identifier
9809895
Citation
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.
Results Reference
result

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

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