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

Stroke Clinical Trial

— IMPACT  

Official title:

The IMPACT of BIOTRONIK Home Monitoring Guided Anticoagulation on Stroke Risk in Patients With ICD and CRT-D Devices

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00559988
• Other study ID #: IMPACT
• Status: Terminated
• Phase: Phase 4
• First received: November 15, 2007
• Last updated: November 1, 2017
• Start date: February 2008
• Est. completion date: June 2013

Study information

• Verified date: November 2017
• Source: Biotronik, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2718
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter
• Embolism
• Embolism, Systemic Arterial
• Major Bleeding
• Stroke

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Denmark,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	Rates of All-cause Mortality		Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Secondary	Rate of Ischemic and Hemorrhagic Stroke		Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Secondary	Rate of Fatal or Disabling and Non-disabling Stroke		Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Secondary	Rate of Major Bleeding Events		Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Secondary	Mean Atrial Fibrillation/Atrial Flutter Burden		Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Secondary	Rate of Cardioembolic and Non-cardioembolic Stroke		Study duration from date of enrollment to date of study exit, with mean implant duration of 2.0 years
Secondary	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.	1 year
Secondary	Mean Ventricular Heart Rate Reduction		1 year