Pulmonary Vein Isolation Alone or in Combination With Substrate Modulation After Electric Cardioversion Failure

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorElsan

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient treated by electric cardioversion for persistent AF, symptomatic and resistant to anti-arrhythmic treatment including amiodarone and whom ablative procedure is planned in the following 4-6 weeks after electric cardioversion

Life expectancy > 5 years;

Female or male between 18 and 80 years of age at the electric cardioversion time

Affiliation to a health insurance system;

Disqualifiers

Current hyperthyroidism;

Pregnant or breastfeeding woman;

Patient with a Body Mass Index (BMI) greater than 35;

Patient with severe Chronic Obstructive Pulmonary Disease (COPD);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pulmonary Vein Isolation (PVI) alone

    Procedure/Surgery

    PVI procedures correspond to point-by-point 50W AI-guided RF applications (400 posterior LA wall, and 550 elsewhere). The PVI will be validated by the absence of any activity recorded inside the PV encirclement by a multipolar catheter (either a Lasso catheter or a Pentaray catheter) (entrance block) and by the non-capture of the LA despite pacing maneuvers from inside the encirclement (exit block). The bidirectional block will be validated again after a 15-minutes waiting period.

  • PVI procedure associated with substrate modulation

    Procedure/Surgery

    PVI procedure associated with substrate modulation

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: PVI procedure aloneActive comparator 1 intervention
Group B: PVI procedure combined with substrate modulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

1-year sinus rhythm maintenance rate

Rate of patients with sinus rhythm (yes/no) at 1 year after a single ablative procedure

Time frame
At 1 year after ablation

Secondary outcomes

1

Rate of patients with sinus rhythm (randomized patients)

Rate of patients with sinus rhythm during 1 year after ablation and after a single ablative procedure.

Time frame
At 1 year after ablation
2

Rate of patients with sinus rhythm (registry patients)

Rate of patients with sinus rhythm during 1 year after ablation and after a single ablative procedure.

Time frame
At 1 year after ablation
3

Rate of patients with sinus rhythm (randomized and registry patients, strategy PVI procedure alone)

Rate of patients with sinus rhythm during 1 year after ablation and after a single ablative procedure.

Time frame
At 1 year after ablation
4

Duration (in minutes) of ablative procedure

Duration (in minutes) of ablative procedure

Time frame
On the day of the ablative procedure

Other outcomes

Sponsors and contacts

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