Atrial FibrillationCAINCT02770989
Vimecon CAI Trial for the Interventional Treatment of Paroxysmal Atrial Fibrillation (AF)
A study testing Vimecon Laser CAI percutaneous cardiac ablation in people with Atrial Fibrillation, run by Vimecon GmbH at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Vimecon Laser CAI percutaneous cardiac ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Mar 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Germany1 site
"Herz- und Diabeteszentrum NRW Klinik für Kardiologie"
Bad Oeynhausen
About this study
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)
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.
Read the 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
- Being tested
- Vimecon Laser CAI percutaneous cardiac ablation
- Keywords
- Cardiac Ablation, Safety, Performance, Laser
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vimecon Laser CAI percutaneous cardiac ablationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Vimecon Laser CAI Cardiac Ablation | Experimental | Ablation of the cardiac tissue by the use of the Vimecon Laser CAI (Cardiac Ablation Instrument). Receives: Procedure: Vimecon Laser CAI percutaneous cardiac ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: < month-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2018
- Study completionSep 2018
Why it stopped: Design change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vimecon GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- René Spaargaren, Dr., Study director, Director Clinical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770989
- Sponsor's protocol ID
- VMC-001
- Acronym
- CAI
- Status last verified
- Oct 2018
- First submitted
- 10 Dec 2015
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02770989
- Acronym / sponsor ID
- CAI / VMC-001
- Conditions
- Atrial Fibrillation
- Keywords
- Cardiac Ablation, Safety, Performance, Laser
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Design change
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Vimecon GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vimecon Laser CAI Cardiac Ablation | Experimental | Procedure: Vimecon Laser CAI percutaneous cardiac ablationAblation of the cardiac tissue by the use of the Vimecon Laser CAI (Cardiac Ablation Instrument). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vimecon Laser CAI percutaneous cardiac ablationThe 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. | Procedure or surgery | Vimecon Laser CAI Cardiac Ablation |
Primary outcome
Safety assessment, free of any Major Adverse Events's or safety events within the first three (3) months after the treatment..
Time frame: < month-3
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
Results and safety
The study was stopped early (reason given: Design change). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
René Spaargaren, Dr. study director
Director Clinical Affairs
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vimecon Laser CAI percutaneous cardiac ablation in people with Atrial Fibrillation, run by Vimecon GmbH at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Czechia, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Design change). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessment, free of any Major Adverse Events's or safety events within the first three (3) months after the treatment.. (time frame: < month-3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018; AzTrials last refreshed its copy on 8 Nov 2026.