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

NCT02770989 | Terminated

• 1 other identifier: VMC-001
• Study Type: interventional
• Target: 1
• Locations: 3 countries
• Sites: 3

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.

Conditions

Atrial Fibrillation

Keywords

Cardiac Ablation; Safety; Performance; Laser

Outcome Measures

Primary Outcomes (1)

• Safety assessment, free of any Major Adverse Events's or safety events within the first three (3) months after the treatment..

  Safety: • Evaluating the proportion of subjects free from experiencing Serious Adverse Events related to the catheter ablation procedure (Major Adverse Events's or safety events) within the first three (3) months after the treatment. Major adverse events (MAE, Safety events) associated with the catheter ablation procedure include: * Cardiac tamponade * Thromboembolic events including pulmonary embolism and stroke * Complete heart block * Acute myocardial infarction * Phrenic nerve palsy * Atrio-esophageal fistula * Vascular complications * Death

  < month-3

Study Arms (1)

Vimecon Laser CAI Cardiac Ablation

EXPERIMENTAL

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

Procedure: Vimecon Laser CAI percutaneous cardiac ablation

Interventions

Vimecon Laser CAI percutaneous cardiac ablation 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.

Vimecon Laser CAI Cardiac Ablation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 75 years.
• 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.
• Patient should be on an anticoagulation therapy according to the international guidelines (per ACC/AHA//ESC Practice Guidelines)
• Left atrial (LA) size \< 50 mm
• Symptomatic AF (EHRA-Score ≥ 2)
• Accessibility of femoral vein and pulmonary veins
• All patients willing to comply with the study protocol for at least 12 months

You may not qualify if:

• \. Inability to give written informed consent
• NYHA Class III and IV
• Hyperthyroidism
• Reversible causes of the AF like Pericarditis, Electrolytic imbalance
• Left Atrial Thrombus formation
• Structural heart disease disturbing accessibility for AF ablation.
• Valvular AF, permanent and long-standing persistent AF, currently present Atrial Flutter
• Any valvular dysfunction more than II°
• Systemic infections or endocarditis.
• Impaired left ventricular function with an ejection fraction of less than 35%
• Kidney dysfunction \>Class III with a GFR of less than 35 mL per minute
• TIA or stroke within the last 6 months
• Pregnant and breastfeeding Women
• Previous relevant cardiac surgery (e.g. ASD, PFO, Maze, AICD, pacemaker, congenital heart disorders or valve replacement).
• Previous ablation of the pulmonary vein.

Sponsors & Collaborators

• Vimecon GmbH: lead

Study Sites (3)

ZNA Middelheim

Antwerp, Belgium

Location

Na Homolce Hospital

Prague, Czechia

Location

"Herz- und Diabeteszentrum NRW Klinik für Kardiologie"

Bad Oeynhausen, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• René Spaargaren, Dr.

  Director Clinical Affairs

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: May 12, 2016
• Study Start: March 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: December 13, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); DE (1); BE (1)