Cardiovascular Diseases Clinical Trial
— CoolLoop PAFOfficial title:
CoolLoop Paroxysmal Atrial Fibrillation
Verified date | March 2019 |
Source | AFreeze GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This clinical investigation evaluates the safety of cryoablation (sclerotherapy of muscle
tissue of the heart by freezing) in paroxysmal atrial fibrillation with the newly developed
CoolLoop® cryoablation catheter.
A further aim of the investigation is the evaluation of the efficacy and average duration of
the applied procedure.
Status | Terminated |
Enrollment | 20 |
Est. completion date | February 14, 2019 |
Est. primary completion date | February 14, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - age 18 - 70 years - symptomatic paroxysmal Atrial fibrillation (AF) - a minimum of three episodes of paroxysmal AF - at least one episode of paroxysmal AF within the last 6 months documented by ECG - signed and dated informed consent documented by the patient - female subjects of childbearing potential can be included, if they: agree to use, and be able to comply with, effective contraception without interruption, from study enrollment, throughout hospitalization and until 12 weeks after catheter ablation Exclusion Criteria: - left atrial diameter > 50 mm in the short axis as assessed by transthoracic echocardiography - advanced structural heart disease including - moderate-to-severe valvular stenosis or regurgitation, - previous valve replacement or valve repair, - congenital heart disease, - left ventricular ejection fraction < 45% during sinus rhythm, - congestive heart failure New York Heart Association (NYHA) III or IV, - coronary artery bypass graft surgery within the last 3 months - chronic obstructive pulmonary disease treated with beta-sympathomimetic drugs - severe respiratory insufficiency - known bleeding diathesis - intolerance of Heparin and/or intolerance of oral anticoagulation - previous AF ablation - permanent pacemaker - left atrial thrombus - intramural or intracardiac thrombus or tumor, or other conditions that may result in difficulties advancing the CoolLoop® cryoablation catheter into the left atrium - access to the vascular system via the right or left femoral vein is not possible - transseptal puncture cannot be achieved due to a previous operation or intervention at the interatrial septum (e.g. closure of a patent foramen ovale or atrial septal defect) - contraindication for transesophageal echocardiography or fluoroscopy - impaired renal function (glomerular filtration rate <30 ml/min.) - history or increased risk of intracranial hemorrhage - history of cerebral ischemic stroke or transient ischemic cerebral attacks within the last 180 days prior to enrolment - severe comorbidity - hyperthyreosis - any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he / she were to participate in the study or confound the ability to interpret data from the study - any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the Informed Consent Form - pregnant or lactating females - other severe conditions, which makes the patient unsuitable to participate in the study, as judged by the Investigator - live-expectancy < 1 year - the patient is active in another clinical trial |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University Innsbruck | Innsbruck | Tirol |
Austria | Allgemeines Krankenhaus der Stadt Linz | Linz | Oberösterreich |
Germany | Klinik für Kardiologie | Bad Oeynhausen | Nordrhein-Westfalen |
Switzerland | UniversitätsSpital Zuerich | Zuerich |
Lead Sponsor | Collaborator |
---|---|
AFreeze GmbH | Accovion GmbH |
Austria, Germany, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of catheter ablation using the CoolLoop® cryoablation catheter determined by the number of patients with device-, or procedure-related serious adverse events. | 12 months follow-up period | ||
Secondary | Measurement of freedom from Atrial Fibrillation (AF) episodes following left atrial catheter ablation using the CoolLoop cryoablation catheter. | Number of patients without AF episodes, determined by continuous ECG recording for 7 days at 1 year after treatment. | from 3 to 12 months after catheter ablation | |
Secondary | Assessment of acute efficacy of catheter ablation defined by Pulmonary Vein (PV) Isolation. | Acute efficacy is defined as the electrical isolation in = 3 PVs at the end of the intervention. Estimated timeframe 360 minutes (average). | from start to end of ablation procedure | |
Secondary | Assessment of the CoolLoop catheter procedure time | Estimated timeframe 360 minutes (average). | from start to end of ablation procedure | |
Secondary | Assessment of the CoolLoop fluoroscopy time | Estimated timeframe 360 minutes (average). | from start to end of ablation procedure | |
Secondary | Assessment of the CoolLoop cryoablation time | Cryoablation time is specified as the cumulative "total freeze time" during treatment. Estimated timeframe 360 minutes (average). | from start to end of ablation procedure | |
Secondary | Assessment of serious and non-serious Adverse Events (SAEs/AEs) | Number of patients with SAEs and AEs | 12 months follow-up period |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
Recruiting |
NCT04417387 -
The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
|
||
Not yet recruiting |
NCT06211361 -
Cardiac Rehabilitation Program in Patients With Cardiovascular Disease
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT04514445 -
The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
|
||
Enrolling by invitation |
NCT04253054 -
Chinese Multi-provincial Cohort Study-Beijing Project
|
||
Completed |
NCT03273972 -
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
|
N/A | |
Completed |
NCT03680638 -
The Effect of Antioxidants on Skin Blood Flow During Local Heating
|
Phase 1 | |
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Completed |
NCT04083846 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed)
|
Phase 1 | |
Completed |
NCT04083872 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting)
|
Phase 1 | |
Completed |
NCT03693365 -
Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
|
||
Completed |
NCT03619148 -
The Incidence of Respiratory Symptoms Associated With the Use of HFNO
|
N/A | |
Completed |
NCT03466333 -
Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia
|
Phase 2 | |
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Completed |
NCT05132998 -
Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors
|
N/A | |
Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|