Vimecon CAI Trial for the Interventional Treatment of Paroxysmal Atrial Fibrillation (AF)

NCT ID: NCT02770989

Last Updated: 2018-12-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-09-30

Brief Summary

This study is a prospective, non-randomized, single arm, multicenter, CE marking trial for patients with paroxysmal atrial fibrillation to undergo an ablation of the cardiac tissue near the PV.

Detailed Description

The objective of this clinical investigation is to confirm the safety and performance of the Vimecon® Laser Cardiac Ablation Instrument when creating scar tissue within the cardiac wall for the treatment of atrial fibrillation.

Up to 66 patients with paroxysmal atrial fibrillation refractory to at least one antiarrhythmic medications (Class I or III) are enrolled. with an expected 10% dropout; 59 per protocol patients are required.

The study duration will be 18 month with a 6 month enrollment period and 12 month follow-up. Interim follow-up visits are at post procedure, 1 Month, 3 Months, 6 Months and 12 Months.

The baseline and follow up tests are standard of care. Additional optional tests are an esophageal endoscopy for determination of potential fistula formation and a cerebral MRI for micro embolism post treatment.

Conditions

Atrial Fibrillation

Keywords

Cardiac Ablation; Safety; Performance; Laser

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vimecon Laser CAI Cardiac Ablation

Ablation of the cardiac tissue by the use of the Vimecon Laser CAI (Cardiac Ablation Instrument).

Group Type: EXPERIMENTAL

Vimecon Laser CAI percutaneous cardiac ablation

Intervention Type: PROCEDURE

The Vimecon Laser CAI catheter is entered through the femoral vein to access the pulmonary vein (PV) area in the heart in order to ablate the cardiac wall near the PV to create scar tissue and to isolate the PV in order to treat atrial fibrillation.

Interventions

Vimecon Laser CAI percutaneous cardiac ablation

The Vimecon Laser CAI catheter is entered through the femoral vein to access the pulmonary vein (PV) area in the heart in order to ablate the cardiac wall near the PV to create scar tissue and to isolate the PV in order to treat atrial fibrillation.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Aged 18 to 75 years.

2. Patients with intention to be treated for paroxysmal atrial fibrillation. AND unresponsive to ≥1 antiarrhythmic drug (class I or III) AND at least 2 episodes in the last 12 months, 1 of them documented.

3. Patient should be on an anticoagulation therapy according to the international guidelines (per ACC/AHA//ESC Practice Guidelines)

4. Left atrial (LA) size < 50 mm

5. Symptomatic AF (EHRA-Score ≥ 2)

6. Accessibility of femoral vein and pulmonary veins

7. All patients willing to comply with the study protocol for at least 12 months

Exclusion Criteria

1. 1. Inability to give written informed consent

2. NYHA Class III and IV

3. Hyperthyroidism

4. Reversible causes of the AF like Pericarditis, Electrolytic imbalance

5. Left Atrial Thrombus formation

6. Structural heart disease disturbing accessibility for AF ablation.

7. Valvular AF, permanent and long-standing persistent AF, currently present Atrial Flutter

8. Any valvular dysfunction more than II°

9. Systemic infections or endocarditis.

10. Impaired left ventricular function with an ejection fraction of less than 35%

11. Kidney dysfunction >Class III with a GFR of less than 35 mL per minute

12. TIA or stroke within the last 6 months

13. Pregnant and breastfeeding Women

14. Previous relevant cardiac surgery (e.g. ASD, PFO, Maze, AICD, pacemaker, congenital heart disorders or valve replacement).

15. Previous ablation of the pulmonary vein.

16. Known or suspected atrial myoma

17. Subject has co-morbid conditions that place the subject at an unacceptable risk (e.g., severe chronic obstructive pulmonary disease, hepatic failure, cerebral degenerative diseases, immunosuppressive abnormalities, hypercoagulable state, nervous system disease and hematological abnormalities.)

18. Contraindicated for the protocol defined anticoagulation plan (per ACC/AHA//ESC Practice Guidelines)

19. Patients with known allergic reactions to the local anesthetic, sedatives, x-ray dye, heparin, protamine, components of the catheter (platinum, iridium, stainless steel) or other agents administered during the procedure.

20. AV-Block IIº and IIIº

21. Contraindication for femoral vein and pulmonary veins access (e.g.: femoral Stent graft, excessive calcification, previous surgical interventions in or adjacent to the femoral veins that impede femoral access)

22. Contraindications for the transseptal approach (e.g.: previous inter-atrial septal patch or surgical interventions in or adjacent to the intro atrial septum)

23. MI in the last 3 months.

24. Enrolled in another clinical trial with a non-CE marked device which has not yet reached its primary endpoint

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vimecon GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

René Spaargaren, Dr.

Role: STUDY_DIRECTOR

Director Clinical Affairs

Locations

ZNA Middelheim

Antwerp, , Belgium

Na Homolce Hospital

Prague, , Czechia

"Herz- und Diabeteszentrum NRW Klinik für Kardiologie"

Bad Oeynhausen, , Germany

Countries

Belgium; Czechia; Germany

Other Identifiers

VMC-001

Identifier Type: -

Identifier Source: org_study_id