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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

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Cardiac Ablation, Safety, Performance, Laser

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

NCT ID

NCT02770989

First Posted

December 10, 2015

Last Updated

December 11, 2018

Sponsor

Vimecon GmbH

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

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

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

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

Learn more about this trial

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

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