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

Biotronik

Status and phase: Terminated; Phase 4

Conditions: Atrial Flutter; Atrial Fibrillation; Major Bleeding; Stroke; Embolism, Systemic Arterial

Treatments: Drug: Physician-Directed OAC; Drug: Home Monitoring Guided OAC

Study type: Interventional

Funder types: Industry

Identifiers

NCT00559988

IMPACT

Details and patient eligibility

About

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.

Full 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

Enrollment: 2,718 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,718 participants in 2 patient groups

Home Monitoring Guided OAC

Experimental group

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.

Treatment:

Drug: Home Monitoring Guided OAC

Physician-Directed OAC

Active Comparator group

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

Treatment:

Drug: Physician-Directed OAC