Assessment of Flecainide to Lower the patent foramen Ovale closure risk of Atrial arrhythmia or Tachycardia

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

23 Mar 2022 → ongoing

Decision date (initial)

2024-05-23

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Association ACTION COEUR

External identifiers

EU CT number

2024-513324-42-00

EudraCT number

2021-002608-10

ClinicalTrials.gov

NCT05213104

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To assess if flecainide is efficient to prevent atrial arrhythmia (AA) occurrence during the 3 months after PFO closure

Secondary objectives 1

1. To assess if 6 months treatment by flecainide is more efficient than 3 months treatment by flecainide to prevent AA occurrence after PFO closure Secondary Endpoint:

Conditions and MedDRA coding

Patent Foramen Ovale Closure Atrial Arrhytmia or Tachycardia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patients are ≥ 18 years of age
2. candidates for a procedure of PFO closure, whatever the indication (secondary prevention of stroke, platypnoea, decompression illness…). The indication must have been confirmed by a multidisciplinary team as recommended by the Haute Autorité de Santé.
3. Affiliated to Social Security
4. Patients have provided a signed written consent form
5. ICM implantation and randomization will occur only in patients with successful PFO closure without any major complications

Exclusion criteria 15

1. History of atrial arrhythmia (paroxysmal, persistent or permanent)
2. Electrocardiographic of ventricular pre-excitation or bundle-branch block (QRS >120ms)
3. Ischemic heart disease
4. Dilated or hypertrophic cardiomyopathy
5. A history of heart failure, severe valvular heart disease, left ventricular dysfunction (ejection fraction <50 percent)
6. long QT interval or Brugada syndrome
7. The bradycardia–tachycardia syndrome (resting heart rate, ≤50 beats per minute, or repetitive sinoatrial blocks during waking hours)
8. Documentation of previous episodes of second or third-degree atrioventricular block
9. High heart rate at baseline > 100 bmp
10. Renal insufficiency (Glomerular filtration rate estimated by the Cockroft and Gault formula <30ml/min/m2),
11. Previous hypokalemia (potassium level <3 mmol per liter)
12. Suspected or known pregnancy (woman of childbearing potential must undergo a pregnancy test)
13. A known hypersensibility to flecainide or its excipients
14. Contemporaneous enrollment in an interventional clinical trial
15. Intended use of a prohibited medication (see 7.4.1)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint of the study will be a blind evaluation of the percentage of patients with at least one episode of symptomatic or asymptomatic AA (≥30s) recorded on long-term monitoring with an insertable cardiac monitor (ICM) during the 3 months after PFO closure AA is defined as any episode of AF, atrial flutter or atrial tachycardia that lasts 30 seconds or more, in accordance with the 2012 consensus statement from the Heart Rhythm Society and others (1).

Secondary endpoints 9

1. - Percentage of patients with at least one episode of symptomatic or asymptomatic AA (≥30s) recorded on long-term monitoring with ICM during the 3-6 months period after PFO closure
2. Percentage of patients with at least one episode of symptomatic or asymptomatic AA (≥6 min) recorded on long-term monitoring with ICM device during the 3 months after PFO closure
3. AA burden and its evolution over time
4. Percentage of patients with at least one episode of symptomatic palpitations during the 3 and 6 months after PFO closure
5. Percentage of patients with at least one episode of fatal or non-fatal stroke or Transient Ischemic Attack (TIA) during the 3 and 6 months after PFO closure
6. Percentage of patients with at least one episode of non-scheduled practitioner-consultation or hospitalization for any cardiovascular reason during the 3 and 6 months after PFO closure
7. All-cause mortality during the 3 and 6 months after PFO closure
8. Percentage of patients with at least one episode of symptomatic or asymptomatic AA (≥6 min) recorded on long-term monitoring with ICM device during the whole follow-up period until battery run out or ICM removal.
9. Rate of Flecainide-related adverse events

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Pr. Gilles Montalescot

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Pr. Gilles Montalescot

Locations

1 EU/EEA country · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications