The clinical study objective is to demonstrate the acute and 12 months safety and performance of the Cryterion Cardiac Cryoablation System when used as intended.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety endpoint is assessed by freedom from device or procedure related serious
adverse events (referred to as Major Adverse Events, MAE) occurring up to 12
months post index procedure. MAEs include the following:
* Death
* Myocardial infarction
* Cardiac perforation/ pericardial tamponade
* Cerebral infarct or systemic embolism
* Major bleeding requiring transfusion of blood products
* Mitral or tricuspid valvular damage
* Phrenic nerve palsy causing persistent diaphragmatic paralysis
* Symptomatic pulmonary vein stenosis
* Atrio-esophageal fistula
* Air embolism leading to a life-threatening event such as a ventricular
arrhythmia, stroke or myocardial infarction
* Any other serious or non-serious adverse device effects (SADEs or ADEs)
Secondary outcome
Secondary endpoints include:
* All Procedure and device related adverse events
* Documentation of all PVs that demonstrate isolation immediately post ablation
and then show reconnection during entrance/exit block testing
* Operator*s assessment of handling characteristics (through a System
Performance Questionnaire) compared to commercially available sheaths circular
mapping catheters and balloon ablation technologies
Background summary
Cryoablation has gained significant popularity and utilization worldwide. With
the understanding the pulmonary veins may be the *cornerstone* of ablation
strategies, a cryo balloon has been developed to provide a *single shot*
therapy for isolation of the pulmonary veins. By navigating the balloon to the
ostium of the PV and occluding flow, a PV may be isolated with a single
cryoablation of 3 - 4 minutes. The currently approved technology (Artic Front*/
Arctic Front Advance* Cryoablation Balloon, Medtronic®) has completed two
landmark studies demonstrating efficacy for PAF management of approximately 70%
and 65% respectively.22,23
Complications arising from cryoablation are consistent with those of heat-based
therapies. Additionally, as the balloon is placed in the right-sided PVs and
near the phrenic nerve, diaphragm paralysis, (both transient and permanent),
has been reported. To mitigate this risk, pacing maneuvers and continuous
analysis of diaphragmatic movement has been used. (Protocol page 20).
Study objective
The clinical study objective is to demonstrate the acute and 12 months safety
and performance of the Cryterion Cardiac Cryoablation System when used as
intended.
Study design
Multi-center, open label, prospective, open enrollment study to document the
safety and performance of the Cryterion Cardiac Cryoablation System.
Intervention
A de novo ablation procedure followed by clinical follow up visits at 1M, 3M,
6M and 12M post procedure.
Study burden and risks
Risks associated with an ablation procedure. Risks associated with the cryo
ablation procedure do not differ from the standard ablation procedure.
Palomar Oaks Way 1949
Carlsbad CA 92011
US
Palomar Oaks Way 1949
Carlsbad CA 92011
US
Listed location countries
Age
Inclusion criteria
IC 1 Male or female between the ages of 18 - 80 years old.
IC 2 Currently scheduled for a de novo ablation of atrial fibrillation (AF)
defined as AF with self-terminating episodes lasting no longer than 7
continuous days (PAF).
IC 3 Willingness, ability, and commitment to participate in baseline and
follow-up evaluations for the full duration of the clinical study.
IC 4 Willing and able to give informed consent.
Exclusion criteria
EC 1 In the opinion of the Investigator, any known contraindication to an AF
ablation, TEE, or anticoagulation
EC 2 Any duration of continuous AF lasting longer than 7 days
EC 3 History of previous left atrial ablation or surgical treatment for
AF/AFL/AT
EC 4 Atrial fibrillation secondary to electrolyte imbalance, thyroid disease,
or any other reversible or non-cardiac cause
EC 5 More than four (4) electrical cardioversions in the year prior to
enrollment excluding cardioversions performed within 24 hours of arrhythmia
onset.
EC 6 Structural heart disease or implanted devices as described below:
a. Left ventricular ejection fraction (LVEF) < 40% based on TTE based on most
recent TTE (* 6 months)
b. Left atrial size > 50mm or left atrial volume index >50 ml/m2 based on most
recent TTE (* 6 months, one measurement of the two being sufficient)
c. An implanted pacemaker or ICD
d. Previous cardiac surgery: ventriculotomy, or atriotomy (excluding atriotomy
for CABG)
e. Previous cardiac valvular surgical or percutaneous procedure, or prosthetic
valve
f. Interatrial baffle, closure device, patch, or PFO occluder
g. Presence of a left atrial appendage occlusion device
h. Presence of any pulmonary vein stents
i. Coronary artery bypass graft (CABG) or PTCA procedure within the last 30 days
j. Unstable angina or ongoing myocardial ischemia
k. Previous myocardial infarction (* 6 months)
l. Moderate or severe mitral insufficiency noted on baseline TTE (* 6 months)
EC 7 Any previous history of cryoglobulinemia
EC 8 History of blood clotting or bleeding disease
EC 9 ANY prior history of documented cerebral infarct, TIA or systemic embolism
(excluding a post-operative DVT)
EC 10 Pregnant or lactating (current or anticipated during study follow up)
EC 11 Current enrollment in any other study protocol where testing or results
from that study may interfere with the procedure or outcome measurements for
this study
EC 12 Any other condition that, in the judgment of the investigator, makes the
subject a poor candidate for this procedure, the study or compliance with the
protocol (includes vulnerable subject population, mental illness, addictive
disease, terminal illness with a life expectancy of less than two years,
extensive travel away from the research center), Secondary Screening: subject
or conducted per physician discretion according to institution*s SOC
EC 1 Any pulmonary vein diameter >30 mm as evidenced by CT scan, LA venogram or
intracardiac echo (ICE)
EC 2 A common long left pulmonary vein ostium as evidenced by CT scan, LA
venogram or ICE that in the judgment of the investigator makes the subject a
poor candidate for this study
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03723070 |
| CCMO | NL70072.078.19 |