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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00559988




Registration number
NCT00559988
Ethics application status
Date submitted
15/11/2007
Date registered
19/11/2007
Date last updated
5/12/2017

Titles & IDs
Public title
Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
Scientific title
The IMPACT of BIOTRONIK Home Monitoring Guided Anticoagulation on Stroke Risk in Patients With ICD and CRT-D Devices
Secondary ID [1] 0 0
IMPACT
Universal Trial Number (UTN)
Trial acronym
IMPACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Atrial Flutter 0 0
Stroke 0 0
Embolism, Systemic Arterial 0 0
Major Bleeding 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Home Monitoring Guided OAC
Treatment: Drugs - Physician-Directed OAC

Experimental: Home Monitoring Guided OAC - 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.

Active Comparator: Physician-Directed 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 O > RV Pacing Impedance > 1500 O
Symptomatic VT/VF therapies including both ATP and shock
VT/VF storm
HM transmission failure >3 days


Treatment: Drugs: Home Monitoring Guided OAC
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

Treatment: Drugs: Physician-Directed OAC
Patients will receive physician-directed anticoagulation therapy based on conventional criteria.
OAC drugs used: Dabigatran etexilate, Rivaroxaban, Warfarin, other approved VKA

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
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 [1] 0 0
Rates of All-cause Mortality
Timepoint [1] 0 0
Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Secondary outcome [2] 0 0
Rate of Ischemic and Hemorrhagic Stroke
Timepoint [2] 0 0
Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Secondary outcome [3] 0 0
Rate of Fatal or Disabling and Non-disabling Stroke
Timepoint [3] 0 0
Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Secondary outcome [4] 0 0
Rate of Major Bleeding Events
Timepoint [4] 0 0
Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Secondary outcome [5] 0 0
Mean Atrial Fibrillation/Atrial Flutter Burden
Timepoint [5] 0 0
Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Secondary outcome [6] 0 0
Rate of Cardioembolic and Non-cardioembolic Stroke
Timepoint [6] 0 0
Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
1 year
Secondary outcome [8] 0 0
Mean Ventricular Heart Rate Reduction
Timepoint [8] 0 0
1 year

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Wahroonga
Recruitment postcode(s) [1] 0 0
- Wahroonga
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
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United States of America
State/province [3] 0 0
Colorado
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United States of America
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Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maine
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nebraska
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New Jersey
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Ohio
Country [23] 0 0
United States of America
State/province [23] 0 0
Oklahoma
Country [24] 0 0
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State/province [24] 0 0
Oregon
Country [25] 0 0
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Pennsylvania
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South Carolina
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Tennessee
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United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
Denmark
State/province [30] 0 0
Aarhus
Country [31] 0 0
Germany
State/province [31] 0 0
Tubingen
Country [32] 0 0
Germany
State/province [32] 0 0
Villingen
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Birmingham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biotronik, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00559988
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jonathan L Halperin, M.D.
Address 0 0
Mount Sinai Medical Center, New York, NY
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00559988