Atrial Fibrillation | UMCG | Previous research-initiated by others
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Previous research-initiated by others

In the last 10 years the group of Rienstra and Van Gelder, participated among others, in the below described studies. In all studies patients visiting the atrial fibrillation-clinic at the University Medical Center Groningen, were asked to participate. In addition to being local investigators for these clinical studies, Rienstra and/or Van Gelder are and were national coordinator or member of the steering committee.

 

Device research

Congestive Heart Failure, Arrhythmia Monitoring and Pacing (CHAMP) study.

Van Gelder was member of the Steering Committee. In this study device-based atrial arrhythmia diagnostics was used to monitor paroxysmal atrial tachycardias, including atrial fibrillation in patients treated with cardiac resynchronization therapy. Results were published in Europace 2010;12, 71–77.

 

AT500 Post–Mode switch Overdrive Pacing (PMOP) study.

In this a randomized controlled study a post–mode switch overdrive pacing (PMOP) algorithm (AT-500, Medtronic) efficacy of overdrive pacing to prevent early recurrences of atrial arrhythmias in patients with documented paroxysmal atrial fibrillation was studied. Results were published in Heart Rhythm 2006;3:1164 –1171.

 

Primary PrEvention PArameters Evaluation (PREPARE) Study.

This was a prospective, cohort-controlled study including patients (biventricular [Bi-V] ICD and non–Bi-V ICD) with primary prevention indications for an ICD. Device were programmed with PREPARE settings and compared with primary prevention patients from the EMPIRIC (Comparison of Empiric to Physician-Tailored Programming of Implantable Cardioverter Defibrillators Trial) and MIRACLE ICD (Multicenter InSync Implantable Cardioversion Defibrillation Randomized Clinical Evaluation) trials for whom ventricular tachycardia/ventricular fibrillation detection and therapy programming were not controlled. The purpose was to demonstrate that strategically chosen implantable cardioverter-defibrillator (ICD) ventricular tachycardia or ventricular fibrillation detection and therapy parameters can reduce the combined incidence of device-delivered shocks, arrhythmic syncope, and untreated sustained symptomatic ventricular tachycardia/ventricular fibrillation. Results were published in J Am Coll Cardiol 2008;52:541–50.

 

ASymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial (ASSERT).

Van Gelder was member of the Steering Committee. Goal was to evaluate whether subclinical episodes of rapid atrial rate detected by implanted devices were associated with an increased risk of ischemic stroke in patients who did not have other evidence of atrial fibrillation. Patients 65 years of age or older, with hypertension and no history of atrial fibrillation, in whom a pacemaker or defibrillator had recently been implanted were included. The patients were monitored for 3 months to detect subclinical atrial tachyarrhythmias (episodes of atrial rate >190 beats per minute for more than 6 minutes) and followed them for a mean of 2.5 years for the primary outcome of ischemic stroke or systemic embolism. Patients with pacemakers were randomly assigned to receive or not to receive continuous atrial overdrive pacing. Results were published in N Engl J Med 2012;366:120-9.

 

Anti-arrhythmic drug research

The Efficacy and safety of dRonedArone for The cOntrol of ventricular rate during atrial fibrillation (ERATO) study.

In this randomized, double-blind, multinational trial, dronedarone, or matching placebo was administered for 6 months to adult patients with permanent atrial fibrillation, in addition to standard therapy. Goal was to assess the efficacy of dronedarone in the control of ventricular rate in patients with permanent atrial fibrillation, when added to standard therapy. Results were published in Am Heart J 2008;156:527.e1-527.e9.

 

Double-Blind, Parallel-Group, Placebo-Controlled Multicentre Phase II Study to Evaluate Safety, Tolerability and Efficacy of AR-H065522XX given Intravenously to Patients for Conversion of Atrial Fibrillation/ Atrial Flutter (STEP) study.

Van Gelder was member of the Steering Committee, Rienstra was local investigator. This study was a randomized, double-blind, placebo-controlled, parallel-group, phase II study. The purpose of this study was to test the proarrhythmic potential, safety, and efficacy of the novel antiarrhythmic agent AZD7009 to convert persistent atrial fibrillation or atrial flutter. Results were published in Heart Rhythm 2006;3:1321–1331.

 

A Phase III Superiority Study of Vernakalant vs Amiodarone in Subjects With Recent Onset Atrial Fibrillation (AVRO) study.

Van Gelder was member of the Steering Committee. In this randomized, controlled study the efficacy and safety of intravenous vernakalant and amiodarone for the acute conversion of recent-onset atrial fibrillation. Results were published in J Am Coll Cardiol 2011;57:313–21.

 

Permanent Atrial FibriLLation Outcome Study Using DronedArone on Top of Standard Therapy (PALLAS) study.

In this randomized, placebo-controlled study the hypothesis that dronedarone would reduce major vascular events in high-risk permanent atrial fibrillation was evaluated. Results were published in N Eng J Med 2011;365:2268-76.

 

Double-blind, International study AssessinG efficacy of S 066913 in paRoxysmal Atrial Fibrillation (DIAGRAF) study.

Van Gelder was national coordinator, Rienstra was local investigator. A randomized, double blind, placebo-controlled, parallel, international multicenter study assessing the efficacy of S 066913 in patients with paroxysmal atrial fibrillation. Study was stopped prematurely.

 

Safety and Efficacy of Vanoxerine for Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm (COR-ART) study.

Van Gelder was member of the Steering Committee. A multicenter, randomized, double-blind, placebo controlled dose modification study to evaluate the safety and efficacy of single oral doses of vanoxerine for conversion of subjects with atrial fibrillation or flutter of recent onset to normal sinus rhythm. Results were published in Heart Rhythm 2015;12(6):1105-12.

 

Anticoagulation research

Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation (AMADEUS) study.

This was a randomised, open-label non-inferiority study with blinded assessment of outcome that compared fixed-dose idraparinux with conventional anticoagulation by dose-adjusted oral vitamin K antagonist therapy for prevention of thromboembolism in patients with atrial fibrillation and an indication for long-term anticoagulation. The aim of this randomised, open-label non-inferiority trial was to compare the effi cacy and safety of idraparinux with vitamin K antagonists. Results were published in Lancet 2008; 371: 315–21.

 

Atrial Fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W) study.

This was 
a randomised controlled trial in patients with atrial fibrillation plus one or more risk factor for stroke, and were randomized to oral anticoagulation therapy or clopidogrel plus aspirin. Goal was to assess whether clopidogrel plus aspirin was non-inferior to oral anticoagulation therapy for prevention of vascular events. Results were published in Lancet 2006; 367: 1903–12.

 

Randomized Evaluation of Long-Term Anticoagulation TherapY (RE-LY) study.

This was a randomized trial designed to compare two fixed doses of dabigatran, each administered in a blinded manner, with open-label use of warfarin in patients who had atrial fibrillation and were at increased risk for stroke. Results were published in N Engl J Med 2009;361:1139-51.

 

Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study.

This was a multi- center, randomized, double-blind, double-dummy, event-driven trial, randomizing patients with nonvalvular atrial fibrillation who were at increased risk for stroke to receive either rivaroxaban or dose-adjusted warfarin. Results were published in N Engl J Med 2011;365:883-91.