Pulmonary Vein Isolation Alone or in Combination With Substrate Modulation After Electric Cardioversion Failure
- Conditions
- Persistent Atrial Fibrillation
- Interventions
- Procedure: Pulmonary Vein Isolation (PVI) aloneProcedure: PVI procedure associated with substrate modulation
- Registration Number
- NCT05264831
- Lead Sponsor
- Elsan
- Brief Summary
This study aims at assessing whether electric cardioversion can act as a discriminant factor between patients requiring Pulmonary Vein Isolation (PVI) procedure alone or PVI procedure combined with substrate modulation.
All included patients will undergo an electric cardioversion, then:
* Patients with electric cardioversion success will be treated as per Standard of Care and according to ESC recommendations (2020). A prospective registry will be implemented for these patients.
* Patients with electric cardioversion failure will be randomized in the study between 2 ablative procedures:
* PVI procedure alone
* PVI procedure combined with substrate modulation
- Detailed Description
Atrial fibrillation (AF) is the most common heart rhythm disorder. It is the result of uncoordinated action of the atrial myocardial cells, causing rapid and irregular contraction of the heart's atria.
The AF prevalence in adults is currently estimated to be between 2% and 4% and is expected to increase by a factor of 2.3 in the next few years, due to the increased longevity of the general population and the increased search for undiagnosed AF. Increased age is an important risk factor for AF, but other increased comorbidities, including hypertension, diabetes, heart failure, coronary artery disease, chronic renal failure, obesity, and obstructive sleep apnoea syndrome, are also important; modifiable risk factors contribute strongly to the development and progression of AF (ESC Guideline, 2020).
The European Society of Cardiology (ESC) recommended pulmonary vein isolation (PVI) (Class IA) as first-line ablative strategy for persistent AF (Class IA) (ESC Guideline, 2020). However, PVI alone is only effective in treating about 40% to 60% of patients with persistent AF in the general population (unselected). If we apply this strategy to all patients (PVI alone), we accept to re-do ablative procedure in up to 60% of patients.
The second feasible strategy is to treat patients with persistent AF by PVI combined with substrate modulation (ESC Class IIb). This strategy, when done well, by creating irreversible lesions (Marshall-PLAN) can effectively treat 70% to 80% of AF patients. But this implies that the investigator will be doing unnecessary substrate modulation in up to 40% of patients, which can lead to increased risks associated with the ablative procedure, longer procedure times, multiple lesions, etc... In addition, incorrect or incomplete substrate modulation is pro-arrhythmic and leads to recurrences in the form of left atrial flutters, tolerance of which, is generally poor.
Both ablative strategies have been widely validated in large numbers of published studies.
The problem is to know when and for which patients to apply one or the other of the two strategies. Electric cardioversion could help in selecting the most appropriate strategy.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PVI procedure alone Pulmonary Vein Isolation (PVI) alone If the patient presents with AF (= failure of electric cardioversion, approximately 30% of patients), randomization will be carried out according to : - Group 1: PVI procedure alone in accordance with ESC recommendations PVI procedure combined with substrate modulation PVI procedure associated with substrate modulation If the patient presents with AF (= failure of electric cardioversion, approximately 30% of patients), randomization will be carried out according to : - Group 2: PVI procedure associated with substrate modulation
- Primary Outcome Measures
Name Time Method 1-year sinus rhythm maintenance rate At 1 year after ablation Rate of patients with sinus rhythm (yes/no) at 1 year after a single ablative procedure
- Secondary Outcome Measures
Name Time Method Rate of patients with sinus rhythm (randomized patients) At 1 year after ablation Rate of patients with sinus rhythm during 1 year after ablation and after a single ablative procedure.
Evaluation of drug treatment use rate or electric cardioversion in the blanking period At three months after ablation Number of patients using drug treatment and/or electric cardioversion during the blanking period (first 3 months after ablation) between the two strategies (randomized patients)
Evaluation of the impact of low voltage areas on the response to EC prior to catheter ablation catheter ablation Relationship between the presence or absence of LA low voltage areas and the response to EC prior to catheter ablation Relationship between the extent of LA low voltage areas and the response to EC prior to catheter ablation Relationship between the location of LA low voltage areas and the response to EC prior to catheter ablation
Rate of patients with sinus rhythm (randomized and registry patients, strategy PVI procedure alone) At 1 year after ablation Rate of patients with sinus rhythm during 1 year after ablation and after a single ablative procedure.
Evaluation of the minor complications rate between the two strategies after 1-year follow-up (randomized patients) up to 1-year follow-up Occurrence of a false aneurysm or fistulas at the puncture sites and/or occurrence of a post-ablation pericardial reaction
Evaluation of the vein isolation as well as other linear lesions in patients with recurrence of atrial fibrillation during 1 year after ablation up to 1-year follow-up Pulmonary vein isolation as well as other linear lesions block assessment during redo procedures
Evaluation of the impact of low voltage areas on the success of the ablation procedure ablation procedure Relationship between the presence or absence of LA low voltage areas and the success of the ablation procedure Relationship between the extent of LA low voltage areas and the success of the ablation procedure Relationship between the location of LA low voltage areas and the success of the ablation procedure
Rate of patients with sinus rhythm (registry patients) At 1 year after ablation Rate of patients with sinus rhythm during 1 year after ablation and after a single ablative procedure.
Duration (in minutes) of radiofrequency use On the day of the ablative procedure Duration (in minutes) of radiofrequency use
Duration (in minutes) of ablative procedure On the day of the ablative procedure Duration (in minutes) of ablative procedure
Duration (in minutes) of Fluoroscopy On the day of the ablative procedure Duration (in minutes) of Fluoroscopy
Duration (in days) of hospitalization From date of surgery until the date of discharge from hospital assessed up to 1 day Duration (in days) of hospitalization
Evaluation of major complications rate Up to 1 year Tamponade and/or stroke rate out of the blanking period and up to 1-year follow-up
Trial Locations
- Locations (13)
Infirmerie Protestante
🇫🇷Caluire Et Cuire, France
Hopital ST Phillbert
🇫🇷Lomme, France
Clinique Rhéna
🇫🇷Strasbourg, France
Hôpital Européen Georges Pompidou Service de cardiologie - Unité rythmologie
🇫🇷Paris, France
CH Libourne
🇫🇷Libourne, France
Clinique St Pierre Cardiologie
🇫🇷Perpignan, France
CCN
🇫🇷Saint-Denis, France
Clinique Pasteur Service de cardiologie/rythmologie
🇫🇷Toulouse, France
CHU Lille
🇫🇷Lille, France
Hôpital Privé Les Franciscaines
🇫🇷Nîmes, France
Chu Nancy
🇫🇷Vandœuvre-lès-Nancy, France
CMC Ambroise Paré Hartmann
🇫🇷Neuilly-sur-Seine, France
CHU Rennes
🇫🇷Rennes, France