Clinical trial NCT06322017: Prospective Multicenter Randomized and Controlled Study Evaluating the Benefit of Early Pulmonary Vein Isolation Compared to Usual Treatment in Patients Aged Over 75 Years and Presenting With Atrial Fibrillation
Official title: Prospective Multicenter Randomized and Controlled Study Evaluating the Benefit of Early Pulmonary Vein Isolation Compared to Usual Treatment in Patients Aged Over 75 Years and Presenting With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Pulmonary vein isolation
Elderly Conventional management
Frailty
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 294
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Man or woman aged 75 and over.
* Paroxysmal AF or early recurrent or persistent paroxysmal AF first diagnosed less than 12 months ago.
* Patient who consented to participate in the study.
* Patient affiliated to a social security system.

Exclusion Criteria:

* Indication of cardiac pacing or defibrillation at baseline.
* History of valve replacement, atrial occlusion or exclusion.
* History of AF ablation.
* Contraindication to anticoagulation or an invasive procedure.
* Significant heart disease (structural with alteration of LVEF \<35%, congenital heart disease, hypertrophic heart disease with wall of more than 15 mm, revascularized coronary syndrome less than 3 months old).
* Stroke less than 6 months old.
* Uncontrolled dysthyroidism.
* Chronic renal failure (CKD - eGFR \<30 µMol/L).
* Patient under curatorship, guardianship, safeguard of justice.
* Life expectancy less than 24 months.
* Participation in another therapeutic trial likely to impact the study evaluation criteria.
* Severe cognitive impairment noted in history.
* Lack of understanding of the study.

Primary outcomes:
measure: Time before occurrence of the first event among cardiovascular death, hospitalization (all causes) and stroke
timeFrame: 2 years
Secondary outcomes:
measure: Number of PVI peri-procedural complications
timeFrame: 48 hours
measure: Number of complications
timeFrame: 2 years
measure: Quality of life score
timeFrame: Inclusion
measure: Quality of life score
timeFrame: 3 months
measure: Quality of life score
timeFrame: 6 months
measure: Quality of life score
timeFrame: 12 months
measure: Quality of life score
timeFrame: 18 months
measure: Quality of life score
timeFrame: 24 months
measure: Number of documented episodes of AF
timeFrame: 2 years
measure: Number of patients treated by cardiovascular drugs
timeFrame: 2 years
measure: Doses of cardiovascular drugs
timeFrame: 2 years
measure: Autonomy score
timeFrame: Inclusion
measure: Autonomy score
timeFrame: 3 months
measure: Autonomy score
timeFrame: 6 months
measure: Autonomy score
timeFrame: 12 months
measure: Autonomy score
timeFrame: 18 months
measure: Autonomy score
timeFrame: 24 months
measure: Autonomy score
timeFrame: Inclusion
measure: Autonomy score
timeFrame: 3 months
measure: Autonomy score
timeFrame: 6 months
measure: Autonomy score
timeFrame: 12 months
measure: Autonomy score
timeFrame: 18 months
measure: Autonomy score
timeFrame: 24 months
measure: Body weight
timeFrame: Inclusion
measure: Body weight
timeFrame: 3 months
measure: Body weight
timeFrame: 6 months
measure: Body weight
timeFrame: 12 months
measure: Body weight
timeFrame: 18 months
measure: Body weight
timeFrame: 24 months
measure: Numbers of falls
timeFrame: Inclusion
measure: Numbers of falls
timeFrame: 3 months
measure: Numbers of falls
timeFrame: 6 months
measure: Numbers of falls
timeFrame: 12 months
measure: Numbers of falls
timeFrame: 18 months
measure: Numbers of falls
timeFrame: 24 months
measure: Physical performance score
timeFrame: Inclusion
measure: Physical performance score
timeFrame: 2 years
measure: Evolution of ADL score according to the results of the Integrated Care for Older People (ICOPE) test at inclusion
timeFrame: 2 years
measure: Evolution of IADL score according to the results of the ICOPE test at inclusion
timeFrame: 2 years
measure: Cognitive assessment
timeFrame: Inclusion
measure: Cognitive assessment
timeFrame: 2 years
measure: Cognitive assessment
timeFrame: Inclusion
measure: Cognitive assessment
timeFrame: 2 years
measure: Cognitive assessment
timeFrame: Inclusion
measure: Cognitive assessment
timeFrame: 2 years
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire Atlantique
Study officials:
affiliation: Nantes University Hospital
name: Jean-Baptiste Gourraud, MD
role: PRINCIPAL_INVESTIGATOR
References: