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Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk (IMPACT)

Primary Purpose

Atrial Fibrillation, Atrial Flutter, Stroke

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Home Monitoring Guided OAC
Physician-Directed OAC
Sponsored by
Biotronik, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Implanted Cardioverter Defibrillator, Cardiac Resynchronization Therapy Defibrillator, Home Monitoring, Oral Anticoagulation

Eligibility Criteria

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

Key Inclusion Criteria:

  • Candidates for implantation of, or already implanted with, a BIOTRONIK Lumax HF-T or DR-T device
  • Documented P wave mean amplitude ≥ 1.0 mV (sinus rhythm) or ≥ 0.5 mV (AF) at enrollment, if previously implanted
  • CHADS2 risk score ≥ 1
  • Able and willing to follow OAC therapy if the indication develops during the course of the trial
  • Able to utilize the HM throughout the study

Key Exclusion Criteria:

  • Permanent AF
  • History of stroke, transient ischemic attack (TIA) or systemic embolism and documented AF or AFL
  • Currently requiring OAC therapy for any indication
  • Patients who underwent successful AF ablation (sinus rhythm restored) and have not completed a minimum of 3 months of OAC therapy
  • Known, current contraindication to use of eligible OAC
  • Long QT or Brugada syndrome as the sole indication for device implantation
  • Life expectancy less than the expected term of the study

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Home Monitoring Guided OAC

Physician-Directed OAC

Arm Description

Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of OAC.

In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed OAC consistent with current standards of care. Safety Net data include: ERI/EOS Special Implant Status Implant in Backup Mode (ROM) VT/ VF Detection Inactive Emergency Pacing 250 Ω > RV Pacing Impedance > 1500 Ω Symptomatic VT/VF therapies including both ATP and shock VT/VF storm HM transmission failure >3 days

Outcomes

Primary Outcome Measures

Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed
The primary endpoint is to demonstrate whether early detection of atrial arrhythmias based on BIOTRONIK Home Monitoring technology combined with a predefined anticoagulation plan in the Home Monitoring Guided OAC group is superior to the Physician-Directed OAC group reflecting conventional care and physician directed treatment of AF in terms of risk reduction of the primary composite endpoint including stroke, systemic embolism, and major bleeding events.

Secondary Outcome Measures

Rates of All-cause Mortality
Rate of Ischemic and Hemorrhagic Stroke
Rate of Fatal or Disabling and Non-disabling Stroke
Rate of Major Bleeding Events
Mean Atrial Fibrillation/Atrial Flutter Burden
Rate of Cardioembolic and Non-cardioembolic Stroke
Change in Quality of Life Score
Quality of Life was evaluated using the SF-36 v2 Health Survey. The SF-36 consists of eight scaled scores which correspond to the following sections: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are recoded per a scoring key with each question having a value from 0 to 100. Scores from items in the same scale are averaged together per the scoring key to create the section and subsection (physical health and mental health) scores. For all reported scores, the lowest possible value is 0 (representing the highest disability) and the highest possible value is 100 (representing no disability). Therefore, a positive change from baseline to 1 year represents an improvement in disability, while a negative change represents a worsening of disability.
Mean Ventricular Heart Rate Reduction

Full Information

First Posted
November 15, 2007
Last Updated
November 1, 2017
Sponsor
Biotronik, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00559988
Brief Title
Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
Acronym
IMPACT
Official Title
The IMPACT of BIOTRONIK Home Monitoring Guided Anticoagulation on Stroke Risk in Patients With ICD and CRT-D Devices
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Study Start Date
February 2008 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The IMPACT Study will investigate the potential clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and physician-directed anticoagulation in patients with implanted dual-chamber defibrillators or cardiac resynchronization therapy devices.
Detailed Description
Atrial fibrillation (AF) and atrial flutter (AFL) are common cardiac arrhythmias associated with an increased incidence of stroke in patients with additional risk factors. Oral Anticoagulation (OAC) reduces stroke risk, but because these arrhythmias are frequently intermittent and asymptomatic, start of OAC therapy is often delayed until electrocardiographic documentation is obtained. Technological advances in implanted dual-chamber cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) devices allow early detection and real time verification of AF/AFL with intracardiac electrograms (IEGM) automatically transmitted to the clinicians. Such remote diagnostic capability might be particularly relevant in patients with asymptomatic AF by allowing timely treatment. Compared to conventional periodic, (e.g., quarterly) office device evaluation, daily remote monitoring may prove superior for diagnosis of AF and prophylactic treatment of thromboembolism. The start, stop and restart of OAC based on a predefined atrial rhythm-guided strategy in conjunction with a standard risk-stratification scheme could lead to better clinical outcomes compared with conventional clinical care. The study is designed to demonstrate a risk reduction of both thromboembolism proximate to episodes of documented AF/AFL and bleeding potentiated by chronic OAC in the absence of AF. Verification of this premise would impact the clinical practice, providing evidence to physicians for the use of HM to guide OAC in patients with AF/AFL. The results of this study should demonstrate the clinical value of wireless remote surveillance of the cardiac rhythm and may define the critical threshold of AF/AFL burden warranting OAC or antiarrhythmic drug therapy in patients at risk of stroke

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Atrial Flutter, Stroke, Embolism, Systemic Arterial, Major Bleeding
Keywords
Implanted Cardioverter Defibrillator, Cardiac Resynchronization Therapy Defibrillator, Home Monitoring, Oral Anticoagulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
2718 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home Monitoring Guided OAC
Arm Type
Experimental
Arm Description
Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of OAC.
Arm Title
Physician-Directed OAC
Arm Type
Active Comparator
Arm Description
In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed OAC consistent with current standards of care. Safety Net data include: ERI/EOS Special Implant Status Implant in Backup Mode (ROM) VT/ VF Detection Inactive Emergency Pacing 250 Ω > RV Pacing Impedance > 1500 Ω Symptomatic VT/VF therapies including both ATP and shock VT/VF storm HM transmission failure >3 days
Intervention Type
Drug
Intervention Name(s)
Home Monitoring Guided OAC
Intervention Description
Active monitoring for atrial episodes through the automatic HM notifications (email, fax, short message service) is required. If the total duration over 48 consecutive hours reaches the predefined anticoagulation condition, and AF/AFL diagnosis is confirmed using the IEGM online, the site instructs the patient by telephone to start OAC. Clinicians continue to monitor patients using HM, and if freedom from AF/AFL reaches the predefined interval, stop of OAC therapy is requested over the telephone. Following stop of anticoagulation, any recurrence of AF/AFL requires restart of OAC therapy. OAC drugs used: Dabigatran etexilate, Rivaroxaban, Warfarin, other approved VKA
Intervention Type
Drug
Intervention Name(s)
Physician-Directed OAC
Intervention Description
Patients will receive physician-directed anticoagulation therapy based on conventional criteria. OAC drugs used: Dabigatran etexilate, Rivaroxaban, Warfarin, other approved VKA
Primary Outcome Measure Information:
Title
Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed
Description
The primary endpoint is to demonstrate whether early detection of atrial arrhythmias based on BIOTRONIK Home Monitoring technology combined with a predefined anticoagulation plan in the Home Monitoring Guided OAC group is superior to the Physician-Directed OAC group reflecting conventional care and physician directed treatment of AF in terms of risk reduction of the primary composite endpoint including stroke, systemic embolism, and major bleeding events.
Time Frame
From date of enrollment until date of primary endpoint event, assessed up to study exit, with a mean treatment duration of 2.0 years
Secondary Outcome Measure Information:
Title
Rates of All-cause Mortality
Time Frame
Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Title
Rate of Ischemic and Hemorrhagic Stroke
Time Frame
Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Title
Rate of Fatal or Disabling and Non-disabling Stroke
Time Frame
Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Title
Rate of Major Bleeding Events
Time Frame
Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Title
Mean Atrial Fibrillation/Atrial Flutter Burden
Time Frame
Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Title
Rate of Cardioembolic and Non-cardioembolic Stroke
Time Frame
Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Title
Change in Quality of Life Score
Description
Quality of Life was evaluated using the SF-36 v2 Health Survey. The SF-36 consists of eight scaled scores which correspond to the following sections: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are recoded per a scoring key with each question having a value from 0 to 100. Scores from items in the same scale are averaged together per the scoring key to create the section and subsection (physical health and mental health) scores. For all reported scores, the lowest possible value is 0 (representing the highest disability) and the highest possible value is 100 (representing no disability). Therefore, a positive change from baseline to 1 year represents an improvement in disability, while a negative change represents a worsening of disability.
Time Frame
1 year
Title
Mean Ventricular Heart Rate Reduction
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Candidates for implantation of, or already implanted with, a BIOTRONIK Lumax HF-T or DR-T device Documented P wave mean amplitude ≥ 1.0 mV (sinus rhythm) or ≥ 0.5 mV (AF) at enrollment, if previously implanted CHADS2 risk score ≥ 1 Able and willing to follow OAC therapy if the indication develops during the course of the trial Able to utilize the HM throughout the study Key Exclusion Criteria: Permanent AF History of stroke, transient ischemic attack (TIA) or systemic embolism and documented AF or AFL Currently requiring OAC therapy for any indication Patients who underwent successful AF ablation (sinus rhythm restored) and have not completed a minimum of 3 months of OAC therapy Known, current contraindication to use of eligible OAC Long QT or Brugada syndrome as the sole indication for device implantation Life expectancy less than the expected term of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan L Halperin, M.D.
Organizational Affiliation
Mount Sinai Medical Center, New York, NY
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
John Ip, M.D.
Organizational Affiliation
Thoracic & Cardiovascular Healthcare Foundation, Lansing, MI
Official's Role
Study Chair
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Phoenix
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Rock Hill
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Germantown
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Corpus Christi
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Sherbrooke
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Aarhus
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12. IPD Sharing Statement

Citations:
PubMed Identifier
25908774
Citation
Martin DT, Bersohn MM, Waldo AL, Wathen MS, Choucair WK, Lip GY, Ip J, Holcomb R, Akar JG, Halperin JL; IMPACT Investigators. Randomized trial of atrial arrhythmia monitoring to guide anticoagulation in patients with implanted defibrillator and cardiac resynchronization devices. Eur Heart J. 2015 Jul 7;36(26):1660-8. doi: 10.1093/eurheartj/ehv115. Epub 2015 Apr 23.
Results Reference
derived

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Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk

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