Vimecon CAI Trial for the Interventional Treatment of Paroxysmal Atrial Fibrillation (AF) (CAI)
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Vimecon Laser CAI percutaneous cardiac ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Cardiac Ablation, Safety, Performance, Laser
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 1. 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.
- Known or suspected atrial myoma
- 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.)
- Contraindicated for the protocol defined anticoagulation plan (per ACC/AHA//ESC Practice Guidelines)
- 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.
- AV-Block IIº and IIIº
- 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)
- Contraindications for the transseptal approach (e.g.: previous inter-atrial septal patch or surgical interventions in or adjacent to the intro atrial septum)
- MI in the last 3 months.
- Enrolled in another clinical trial with a non-CE marked device which has not yet reached its primary endpoint
Sites / Locations
- ZNA Middelheim
- Na Homolce Hospital
- "Herz- und Diabeteszentrum NRW Klinik für Kardiologie"
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vimecon Laser CAI Cardiac Ablation
Arm Description
Ablation of the cardiac tissue by the use of the Vimecon Laser CAI (Cardiac Ablation Instrument).
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02770989
Brief Title
Vimecon CAI Trial for the Interventional Treatment of Paroxysmal Atrial Fibrillation (AF)
Acronym
CAI
Official Title
A Clinical Trial for the Assessment of the Safety and Performance of the Vimecon Laser Cardiac Ablation Instrument (CAI) for the Interventional Treatment of Paroxysmal Atrial Fibrillation (AF)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Design change
Study Start Date
March 2016 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vimecon GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Cardiac Ablation, Safety, Performance, Laser
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vimecon Laser CAI Cardiac Ablation
Arm Type
Experimental
Arm Description
Ablation of the cardiac tissue by the use of the Vimecon Laser CAI (Cardiac Ablation Instrument).
Intervention Type
Procedure
Intervention Name(s)
Vimecon Laser CAI percutaneous cardiac ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety assessment, free of any Major Adverse Events's or safety events within the first three (3) months after the treatment..
Description
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
Time Frame
< month-3
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
1. 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.
Known or suspected atrial myoma
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.)
Contraindicated for the protocol defined anticoagulation plan (per ACC/AHA//ESC Practice Guidelines)
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.
AV-Block IIº and IIIº
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)
Contraindications for the transseptal approach (e.g.: previous inter-atrial septal patch or surgical interventions in or adjacent to the intro atrial septum)
MI in the last 3 months.
Enrolled in another clinical trial with a non-CE marked device which has not yet reached its primary endpoint
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
René Spaargaren, Dr.
Organizational Affiliation
Director Clinical Affairs
Official's Role
Study Director
Facility Information:
Facility Name
ZNA Middelheim
City
Antwerp
Country
Belgium
Facility Name
Na Homolce Hospital
City
Prague
Country
Czechia
Facility Name
"Herz- und Diabeteszentrum NRW Klinik für Kardiologie"
City
Bad Oeynhausen
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Vimecon CAI Trial for the Interventional Treatment of Paroxysmal Atrial Fibrillation (AF)
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