NCT00559988 (IMPACT) is a Phase 4 clinical trial of Home Monitoring Guided OAC in Atrial Fibrillation, sponsored by Biotronik, Inc..

Who is sponsoring NCT00559988?

NCT00559988 is sponsored by Biotronik, Inc..

What drugs are being tested in NCT00559988?

Interventions in NCT00559988: Home Monitoring Guided OAC, Physician-Directed OAC.

What condition does NCT00559988 study?

NCT00559988 studies Atrial Fibrillation, Atrial Flutter, Stroke, Embolism, Systemic Arterial, Major Bleeding.

Is NCT00559988 still recruiting?

NCT00559988 is currently terminated. Last updated 1 November 2017.

Are results published for NCT00559988?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-11-01 · How we verify

NCT00559988: IMPACT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 4 Results posted Last updated 1 November 2017

What this trial tests

Phase 4 trial testing Home Monitoring Guided OAC in Atrial Fibrillation in 2,718 participants. Terminated before completion.

Timeline

1 February 2008

Primary endpoint
1 June 2013

1 June 2013

Quick facts

Lead sponsor	Biotronik, Inc.
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	2,718
Start date	1 February 2008
Primary completion	1 June 2013
Estimated completion	1 June 2013
Sites	80 locations across United States, Australia, Canada, Denmark, Germany, United Kingdom

Drugs / interventions tested

Home Monitoring Guided OAC — full drug profile →
Physician-Directed OAC — full drug profile →

Conditions studied

Atrial Fibrillation — all drugs for Atrial Fibrillation →
Atrial Flutter — all drugs for Atrial Flutter →
Stroke — all drugs for Stroke →
Embolism, Systemic Arterial — all drugs for Embolism, Systemic Arterial →

Sponsor

Biotronik, Inc. — full company profile →

Who can join

18 and older, any sex, with Atrial Fibrillation or Atrial Flutter. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed
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
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 incl

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Randomized trial of atrial arrhythmia monitoring to guide anticoagulation in patients with implanted defibrillator and cardiac resynchronization devices.
Martin DT, Bersohn MM, Waldo AL, Wathen MS, et al · · 2015 · cited 270× · PMID 25908774 · DOI 10.1093/eurheartj/ehv115
Characteristics of patients with atrial high rate episodes detected by implanted defibrillator and resynchronization devices.
Miyazawa K, Pastori D, Martin DT, Choucair WK, et al · · 2022 · cited 21× · PMID 34426836 · DOI 10.1093/europace/euab186
Can Machine Learning Disrupt the Prediction of Sudden Death?
Narayan SM, Rogers AJ. · · 2023 · cited 2× · PMID 36889874 · DOI 10.1016/j.jacc.2022.12.027
Atrial fibrillation and stroke: the evolving role of rhythm control.
Patel TK, Passman RS. · · 2013 · cited 1× · PMID 23397289 · DOI 10.1007/s11936-013-0234-9
Trends of Decentralized Clinical Trials Using Digital Technology for Decentralization
Sato T, Mizumoto S, Ota M, Shikano M. · · 2022 · DOI 10.2139/ssrn.4243284

Verify or expand the search:

Other recruiting trials for Atrial Fibrillation

Currently open trials in the same condition.

NCT07429214 — A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF · NA · recruiting
NCT07271238 — Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures · NA · recruiting
NCT07388108 — Atrial Dyssynchrony to Predict Arrhythmias in the Postoperative Setting of Cardiovascular Surgery. · recruiting
NCT07428967 — AV Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function · NA · recruiting
NCT06650995 — AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure · NA · recruiting

Other Biotronik, Inc. trials

Trials by the same sponsor.

NCT05251363 — BIOTRONIK Conduction System Pacing With the Solia Lead · NA · completed
NCT04870281 — Atrial Fibrillation Associated With Heart Failure Treated by BIOTRONIK's CRT-DX System · terminated
NCT04175626 — Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions · completed
NCT04076917 — Assessment of the Utility of BIOMONITOR to Identify Atrial Fibrillation (AF) in Ablation Candidates Using Precise AF Det · terminated
NCT03884608 — Analysis of Both Sex and Device Specific Factors on Outcomes in Patients with Non-Ischemic Cardiomyopathy · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00559988 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biotronik, Inc.
Last refreshed: 1 November 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00559988.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing