Atrial Fibrillation | UMCG | Ongoing investigator-initiated research
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Ongoing investigator-initiated research

Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department (ACWAS) study

This is a randomized, open-label, multi-center trial. The principal investigator is prof.dr. Crijns, and prof.dr. Van Gelder and dr. Rienstra, are members of the steering committee. Symptomatic episode of atrial fibrillation is a frequent reason for visits to the emergency department. Currently, in the majority of cases, immediate (electrical or pharmacological) cardioversion is chosen, while atrial fibrillation terminates spontaneously in 70% of the cases within 24 hours. Patients with atrial fibrillation visiting the emergency department are randomized to a wait-and-see approach or usual care, cardioversion therapy. Primary objective is to investigate whether a wait-and-see approach is an effective and more cost-effective than usual care, cardioversion approach. Study inclusion is ongoing (goal: 437 patients).

ClinicalTrials.gov Identifier: NCT02248753

Sponsor: Maastricht University Medical Center

Financial support: Netherlands Organisation for Health Research and Development (ZonMW)

 

Identification of a risk profile to guide atrial fibrillation therapy (AF-Risk) registry

The Identification of a risk profile to guide atrial fibrillation therapy (AF-RISK) study is a multi-center, prospective, observational study, led by dr. Rienstra and prof.dr. Van Gelder. A total of 500 patients with short-lasting symptomatic paroxysmal or persistent atrial fibrillation in whom a rhythm control strategy was preferred were included. Clinical factors, echocardiographic parameters, and blood samples for analysis of circulating biomarkers have been collected in order to determine the factors associated with success of rhythm control. Patients are seen regularly during a 1-year-follow up and rhythm monitoring is performed by Holter and 2-week eventrecording.

ClinicalTrials.gov Identifier: NCT01510210

Sponsor: University Medical Center Groningen (UMCG)

Financial support: Netherlands Heart Foundation (NHS2010B233), Center for Translational Molecular Medicine

 

Identification of a risk profile to guide atrial fibrillation therapy in patients with atrial fibrillation (Biomarker-AF) registry

The Biomarker-AF study is a single-center, prospective observational study performed in the University Medical Center Groningen (UMCG) initiated and performed by prof.dr. I.C. van Gelder and dr. M. Rienstra. In total, 500 consecutive individuals with <10 years of symptomatic paroxysmal or (long-standing) persistent atrial fibrillation in whom a rhythm control strategy is preferred, were included, and in addition to routine cardiology investigations, blood sampling is performed at inclusion, and follow up will be 60 months.

ClinicalTrials.gov Identifier: NCT01510197

Sponsor: University Medical Center Groningen (UMCG)

Financial support: University Medical Center Groningen (UMCG)

 

Phenotyping young-onset atrial fibrillation patients (Young-AF) registry

The phenotyping young-onset atrial fibrillation patients (Young-AF) study is a single center, prospective, observational study, led by dr. Rienstra and prof.dr. Van Gelder. Consecutive patients with onset of atrial fibrillation <60 years of age were asked to participate. A total of 500 patients were included. The primary objective is to define the phenotype of young patients with atrial fibrillation. Data regarding clinical characteristics, atrial fibrillation risk factors, electro- and echocardiographic abnormalities, and circulating biomarkers was collected.

Sponsor: University Medical Center Groningen (UMCG)

Financial support: University Medical Center Groningen (UMCG)

 

Hybrid Atrial Fibrillation registry

This is a prospective, non-randomized, observational study in patients undergoing hybrid atrial fibrillation ablation to treat atrial fibrillation, led by dr. Blaauw, dr. Rienstra, prof. dr. Van Gelder, and prof. dr. Mariani. This procedure has emerged as a promising option to treat the difficult cases of atrial fibrillation that are refractory to the other available options. It combines two approaches in one procedure, a thoracoscopic approach where the cardiac surgeon makes multiple lines to isolate the areas from which atrial fibrillation arises, and a percutaneous approach where the electrophysiologist creates a map for the electrical activity in the atria to assess its conduction state, and then closes the remaining gaps in the lines made by the surgeons, if any are found, and eventually isolate any other areas that might be responsible for abnormal heart rhythm. In this study we are investigating the short- and long-term outcomes of this procedure, as well as the factors that could help us identify the most suitable patients to optimize its efficacy and safety in the future.

ClinicalTrials.gov Identifier: NCT02516033

Sponsor: University Medical Center Groningen

Financial support to the institution: AtriCure Europe BV

 

Markers And Response to CRT (MARC) study

This is a multi-center, prospective, non-randomized, observational study in 240 symptomatic heart failure patients with a reduced left ventricular ejection fraction and a prolonged QRS duration receiving cardiac resynchronisation therapy (CRT). Principal investigators are prof.dr. I.C. Van Gelder and dr. A.H. Maass. Dr. Rienstra is member of the steering committee. CRT is an established device therapy for patients with systolic heart failure despite optimal medical treatment. CRT can reduce heart failure hospitalizations and mortality and improves exercise capacity and quality of life, but a significant number of patients show no clinical improvement after implantation. To improve prediction of the beneficial effects of CRT the MARC study investigates the relationship of a set of (bio)markers and response to CRT. The interrelationship as well as the potential predictive power of these (bio)markers on improvement or deterioration of cardiac function and cardiac geometry is evaluated. Dr. Rienstra and Dr. Geelhoed are the statistical core lab for all substudies. Study is completed.

ClinicalTrials.gov Identifier: NCT01519908

Sponsor: University Medical Center Groningen (UMCG)

Financial support: Netherlands Heart Foundation, Center for Translational Molecular Medicine, InterUniversity Cardiology Institute Netherlands, Medtronic Bakken Research Center BV

 

Routine versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure (RACE 3) study

This is a randomized, open-label, multi-center trial led by prof.dr. Van Gelder, and prof.dr. Crijns. Dr. Rienstra is member of the steering committee. Patients (n=250) with early atrial fibrillation and mild to moderate early systolic or diastolic heart failure are randomized to an aggressive upstream rhythm control approach including aldosterone receptor antagonists and statins, dietary restrictions, counseling and cardiac rehabilitation programs, or conventional rhythm control. In both groups, electrical cardioversions will be performed as well as institution of ion channel antiarrhythmic drugs and pulmonary vein isolation in case of recurrent atrial fibrillation. Primary objective is to investigate whether an aggressive upstream rhythm control approach increases the persistence of sinus rhythm compared with conventional rhythm control, in patients with early atrial fibrillation and mild to moderate early heart failure. Study follow-up is ongoing.

ClinicalTrials.gov Identifier: NCT00877643

Sponsor: University Medical Center Groningen

Financial support: Netherlands Heart Foundation, Interuniversity Cardiology Institute Netherlands, Working group on Cardiovascular Research, the Netherlands, Sanofi Aventis, Boehringer Ingelheim, Medtronic, Biotronik, St Jude Medical, Boston Scientific, AstraZenenca

 

IntegRAted CarE for Atrial Fibrillation (RACE 4) study

This is a randomized, open-label, multi-center trial led by prof.dr. Crijns, dr. Tieleman, and prof.dr. Van Gelder. Dr. Rienstra is local investigator at the University Medical Center Groningen. Patients with new-onset atrial fibrillation are randomized to an integrated chronic care program at a specialized atrial fibrillation clinic or usual care provided by the cardiologist. The primary objective of the study is to show that an integrated chronic care program at a specialized atrial fibrillation clinic reduces cardiovascular hospitalizations and mortality. The secondary objectives contain the cost effectiveness of the integrated chronic care program, guideline adherence, quality of life, patient knowledge and patient compliance in medication. Study inclusion is ongoing (goal: 1716 patients).

ClinicalTrials.gov Identifier: NCT01740037

Sponsor: Maastricht University Medical Center

Financial support: Achmea, DSW, CZ Fonds, Boehringer Ingelheim, Bayer, Bristol-Myers- Squibb, Pfizer and Daiichi

 

The Reappraisal of Atrial Fibrillation: Interaction between hyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of Atrial Fibrillation (RACE V) registry

This is a multicenter, observational exploratory registry, led by prof.dr. Van Gelder, prof.dr. Crijns, and dr. Rienstra, on pathophysiological mechanisms of atrial fibrillation progression and on the role of LinQ/ CareLink guided patient tailored therapy in patients with atrial fibrillation. This registry concerns the extensive phenotyping in patients with paroxysmal self-terminating atrial fibrillation, in conjunction with continuous atrial rhythm monitoring, to elucidate the role of hypercoagulability and other potential mechanisms in atrial fibrillation progression and to identify patients at risk for atrial fibrillation progression. In addition, the feasibility of implementing changes in therapy in patients with selfterminating atrial fibrillation using the LinQ/ Carelink system will be studied. A total of 750 patients with self-terminating, paroxysmal atrial fibrillation will be included. Inclusion of patients is ongoing. Phenotyping will be done by collection of clinical parameters, and by vascular assessment, CT-heart, echocardiography, DNA and circulating biomarkers collection – with special interest in hypercoagulability. Patients will receive continuous rhythm monitoring by either a Medtronic Reveal LINQ or a Medtronic Advisa pacemaker. Total follow up will be 2.5 years. Primary endpoint is development of atrial fibrillation progression. The RACE V registry is part of the RACE V consortium.

ClinicalTrials.gov Identifier: NCT02726698

Sponsor: University Medical Center Groningen

Financial support: Netherlands Cardiovascular Research Initiative and Medtronic

 

Ventricular tachyarrhythmia detection by Implantable Loop Recording in Patients with Heart Failure and Preserved Ejection Fraction (VIP-HF) registry

This is a prospective, non-randomized observational study in patients with heart failure with preserved ejection fraction, led by prof.dr. Van Veldhuisen en dr. Rienstra. This type of heart failure account for approximately half of all new heart failure cause and is a large medical problem, for which no drug or device has a recommendation in current heart failure guidelines. Sudden cardiac death is suggested as the most common cause of death in heart failure with preserved ejection fraction, although data are scarce. In the VIP-HF study we use implantable loop recorders to investigate the incidence of sustained ventricular tachyarrhythmias and new onset atrial fibrillation in patients with heart failure with preserved ejection fraction. Study inclusion is ongoing (goal: 250 patients).

ClinicalTrials.gov Identifier: NCT01989299

Sponsor: University Medical Center Groningen

Financial support to the institution: St. Jude Medical