Nantes University Hospital
Nantes, Loire Atlantique, 44093, France
Location status: Recruiting
NCT Number: NCT06322017
Therapeutic management of Atrial Fibrillation (AF) is based either on heart rate control or on rhythm control, a strategy which aims to maintain a normal heart rhythm. The benefit in terms of morbidity and mortality of a normal heart rhythm would, however, be largely offset by the frequent side effects of antiarrhythmic drugs which could even lead to an increase in mortality compared to rate control. This increase has particularly been suggested in people aged over 75.
Since the emergence of catheter Pulmonary Vein Isolation (PVI), an effective alternative to antiarrhythmic drugs has become available. This technique makes it possible to isolate the foci triggering AF under local or general anesthesia with greater effectiveness than medications and very low risks. Records in the elderly do not seem to show a reduction in effectiveness or an increase in complications. However, in the absence of a dedicated randomized study, its use is strongly limited in the elderly where rate control (52% of people over 65 years old) and the use of antiarrhythmic drugs are largely favored due to the simplicity of implementation and the low cost of medications.
However, an early rhythm control strategy seems to reduce cardiovascular events in relatively old individuals (average age 70 years). The use of PVI in first line could make it possible to further improve these results.
The objective of the investigator is therefore to carry out the first randomized comparative study proposing to evaluate the impact of early PVI compared to usual treatment in patients aged 75 and over with AF.
Interested in participating?
Request Info75 year and older
All sexes
Interventional
Not applicable
Nantes, Loire Atlantique, 44093, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The PVI procedure involves the creation of a circumferential lesion around the ostium of the four pulmonary veins.
The choice of the type of energy to insure the lesion will be left to the discretion of the investigator, according to the center's habits and the patient's anatomy found on the scanner.
Ventricular rate control is carried out using negative chronotropic agents (e.g. beta-blockers, calcium channel blockers, digitalis, etc.) according to current recommendations. If this fails, ablation of the atrioventricular junction with placement of a permanent pacemaker can be carried out according to current recommendations. As part of this research, the choice of bradycardic drugs and interventions will be left to the discretion of the investigator according to the center's practices and current recommendations.
Rhythm control aims to reduce AF by cardioversion (if it persists) to restore sinus rhythm and subsequently maintain it by introducing anti-arrhythmic treatment. Several antiarrhythmic drugs (flecainide, sotalol or amiodarone) can be used in this setting. As part of this research, the choice of antiarrhythmic drugs will be left to the discretion of the investigator according to the center's practices and current recommendations.
Time frame: 2 years
Days
Time frame: 48 hours
Time frame: 2 years
Time frame: Inclusion
EQ-5D-5L score
Time frame: 3 months
EQ-5D-5L score
Time frame: 6 months
EQ-5D-5L score
Time frame: 12 months
EQ-5D-5L score
Time frame: 18 months
EQ-5D-5L score
Time frame: 24 months
EQ-5D-5L score
Time frame: 2 years
Time frame: 2 years
Time frame: 2 years
milligrams
Time frame: Inclusion
Activities of Daily Living (ADL) score
Time frame: 3 months
ADL score
Time frame: 6 months
ADL score
Time frame: 12 months
ADL score
Time frame: 18 months
ADL score
Time frame: 24 months
ADL score
Time frame: Inclusion
Instrumental Activities of Daily Living (IADL) score
Time frame: 3 months
IADL score
Time frame: 6 months
IADL score
Time frame: 12 months
IADL score
Time frame: 18 months
IADL score
Time frame: 24 months
IADL score
Time frame: Inclusion
kilograms
Time frame: 3 months
kilograms
Time frame: 6 months
kilograms
Time frame: 12 months
kilograms
Time frame: 18 months
kilograms
Time frame: 24 months
kilograms
Time frame: Inclusion
Time frame: 3 months
Time frame: 6 months
Time frame: 12 months
Time frame: 18 months
Time frame: 24 months
Time frame: Inclusion
Short Physical Performance Battery (SPPB) test score
Time frame: 2 years
SPPB test score
Time frame: 2 years
Time frame: 2 years
Time frame: Inclusion
Mini-Mental State Examination (MMSE) score
Time frame: 2 years
MMSE score
Time frame: Inclusion
Batterie Rapide d'Efficience Frontale (BREF) score
Time frame: 2 years
BREF score
Time frame: Inclusion
Mini Geriatric Depression Scale (GDS) score
Time frame: 2 years
Mini GDS score
Contact information is provided by the study sponsor or research team.
Nantes University Hospital
Other
Acronym: EDearly AF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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