The objective of the study is to demonstrate the safety and performance of the Adagio Cryoablation System in patients with paroxysmale (PAF), persistent or Long-Standing Persistent Atrial Fibrillation.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety: The primary safety endpoint will be determined by evaluating:
• the incidence of procedural adverse events
• the incidence of serious adverse events within 7 days of procedure, > 7 days,
and > 30 days
Performance: Technical performance assessed by:
• complete electrical isolation of all pulmonary veins (entrance block)
• AF termination targeting driver regions, when applicable
• complete linear block of linear lesions if deployed
Secondary outcome
Performance: performance assessed by:
• percentage of RF focal ablation (touch up) to reach the primary performance
endpoint
• procedural parameters (fluoro, ablation and total procedural times)
• complete freedom from documented AF or other atrial tachycardia (> 30 s),
using 48-hour Holter monitor at 12 months post ablation, after a single
procedure and off AAD (Anti Arrhythmic Drug) (includes a three month blanking
period).
Background summary
Treatment of AF represents a significant health care burden. The estimated
cost of the treatment of AF in 2005 was $6.65 billion per year, including the
costs of hospitalization, in- and outpatient physician care, and medications.
As many as 12 million people will have the condition by 2050.
Catheter ablation of AF is the treatment of choice for drug-resistant,
symptomatic patients and is the most frequent ablation procedure performed
worldwide. However, the main challenge remains in the field of AF ablation,
probably being responsible for most ablation failures and the need for repeat
procedures in a significant number of patients. It is recurrent pulmonary vein
conduction.
Almost all patients experiencing recurrent AF after pulmonary vein isolation
for AF have at least one reconducting and actively firing pulmonary vein
responsible for arrhythmia recurrence. The importance of pulmonary vein
reconnection has been confirmed in many studies and has led to the postulate
that electrical reconnection of the veins is an important mechanism of AF
recurrence following catheter ablation.
The rational for the CryoCure2 clinical study investigation is to evaluate a
procedure and device that provides linear, transmural lesions for acute and
long-term success of treating paroxysmal AF ablation without the need for
repeat ablations.
Study objective
The objective of the study is to demonstrate the safety and performance of the
Adagio Cryoablation System in patients with paroxysmale (PAF), persistent or
Long-Standing Persistent Atrial Fibrillation.
Study design
80 patients with AF will be enrolled in prospective, multicenter,
non-randomized and non-controlled investigation.
Intervention
The Cryoablation System achieves its intended purpose by creating and
controlling the conditioning of Nitrogen to its critical point (CN2) within the
Cryoablation console and subsequently creating an uninterrupted flow of this
cooling agent (cryogen) through the Cryoablation catheter.
The Cryoablation Console contains an internal reservoir of liquid nitrogen that
is used to pre-cool the CN2 cryogen to approximately -196°C. This cryogen is
then delivered to the Cryoablation Catheter where it circulates within closed,
internal lumens that are surrounded and insulated by a vacuum channel. The
targeted cardiac tissue is exposed to cryogenic temperatures at the only
non-insulated portion of the catheter. This non-insulated portion is located at
the distal tip and referred to as the freeze zone, which is continuously
monitored and measured by an internal thermocouple.
The Cryoablation Catheter is delivered to the upper chambers of the human heart
via common femoral vein cannulation and trans septal puncture, and positioned
such that the freeze zone (treatment area) is adjacent to the targeted tissue.
After the desired position and catheter-tissue contact have been obtained, a
freeze cycle is initiated through the interactive touch screen on the console.
The chilled CN2 fluid will begin circulating through the catheter and
delivering treatment to the tissue adjacent to the freeze zone. The tissue
that is in thermal contact with the distal freeze zone will cool to cryogenic
temperatures, resulting in necrosis (ablation) of the tissue and the creation
of a linear lesion. After the cryogen circulates back into the console, it is
automatically heated up to ambient temperature and safely vented into the
atmosphere.
The design of the Cryoablation Catheter enables the creation of continuous
lesion defined by the shape of the catheter, providing a greater assurance that
the arrythmogenic tissue/regions are isolated, which will result in normal
sinus rhythm.
Study burden and risks
The ablation procedure is not experimentally. The Cryoablation system, which is
used during the ablation procedure, is experimental. Pulmonary vein isolation
ablation is a safe procedure, however as with any procedure, there are
potential risks. The investigational device does not require deviation from
the hospital regular medical care for this type of procedure. The use of the
Cryoablation system is potentially just as safe as the usual treatment,
however, since the treatment involves an experimental catheter, previously
unknown side effects may occur, the effect of the treatment may be less than
expected or there may be no effect at all.
Use of an ablation catheter could cause prolonged illness, permanent impairment
of daily function, or in rare cases, death. These risks are typically
controlled through the use of medications, and a variety of other devices and
procedures.
The patient Atrial Fibrillation may improve while you are in this study;
however, this cannot be promised. The results of this study may help people
with Atrial Fibrillation in the future.
26051 MERIT CIRCLE, SUITE 102, LAGUNA HILLS 26051 MERIT CIRCLE, SUITE 102, LAGUNA HILLS
CALIFORNIA 92653
US
26051 MERIT CIRCLE, SUITE 102, LAGUNA HILLS 26051 MERIT CIRCLE, SUITE 102, LAGUNA HILLS
CALIFORNIA 92653
US
Listed location countries
Age
Inclusion criteria
1. Patient is diagnosed with Paroxysmal (PAF), Persistent (PsAF) or Long-Standing Persistent atrial fibrillation for which an ablation procedure was deemed most appropriate therapy:
Paroxysmal AF is defined as recurrent atrial fibrillation (AF) that terminates spontaneously within seven (7) days. Persistent AF is defined as: an episode lasting longer than seven (7) days, but less than one (1) year documented by consecutive ECG recordings of 100% AF greater than seven (7) days apart or an episode requiring electrical or pharmacological cardioversion after 48 hours of AF documented by continuous recording. Long-Standing Persistent AF is defined as continuous AF that lasts longer than one (1) year.
2. Reported incidence of at least one (1) documented episode of symptomatic AF during the twelve (12) months preceding trial entry (should be documented by rhythm strip or ECG).
3. Failure of at least one (1AAD for AF [class I or III, or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)] as evidenced by recurrent symptomatic AF, or intolerable side effects due to AAD.
Exclusion criteria
1. Patient had any previous left atrial ablation.
2. History of any valvular cardiac surgical procedure, atrial septal defect closure device; or left atrial appendage closure device.
3. Coronary artery bypass grafting (CABG) procedure within the last 3 months.
4. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
5. Atrial clot/thrombus on imaging such as on a trans-esophageal echocardiogram (TEE) performed within 48 hours of the procedure if deemed appropriate by the investigator.
6. History of a documented thromboembolic event within the past one (1) year.
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 |
|---|---|
| CCMO | NL56940.100.16 |