The objective of the study is to demonstrate the safety and feasibility of the Adagio Cryoablation System in subjects with Atrial Flutter (AFL).
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety: Percentage of subjects experiencing cardiovascular specific adverse
events (CSAE) within thirty 30 days of the ablation procedure.
Secondary outcome
*Acute Success: Percentage of subjects with termination of AFL and complete
bidirectional conduction block across the subeustachian
(cavo-*tricuspid) isthmus at the end of the ablation procedure.
*Outcome success: Percent of subjects with absence of AFl at 180 days.
Background summary
The aim of this study is to evaluate the Adagio Cryoablation System when used
in subjects diagnosed with an abnormal heart rhythm called Atrial Flutter.
The Adagio Cryoablation System is a device that treats Atrial Flutter by
applying very cold temperatures to areas of the heart muscle using a small
catheter. When the very cold temperatures are applied to certain areas of the
heart it creates a *line* in the heart tissue that may stop the Atrial Flutter.
Study objective
The objective of the study is to demonstrate the safety and feasibility of the
Adagio Cryoablation System in subjects with Atrial Flutter (AFL).
Study design
The study is a Prospective, Multicenter, Investigation of the Adagio
Cryoablation System in Subjects with Arterial Flutter
Intervention
The Adagio Cryoablation System consist of the Cryoablation ablation catheter
and a Cryoablation console. The Adagio Cryoablation System creates cryothermy
energy by pressurizing nitrogen to critical pressures (CN2).
The Adagio Cryoablation Catheter includes closed, internal lumen where non-*
insulated portions (freeze zone) achieve cryoablation temperatures. The freeze
zone (distal tip / portion) is the only portion of the catheter where
cyrothermy energy is distributed or exposed, a vacuum channel
surrounds the closed, internal lumens insulating the non-*freezing portions
from cold temperatures. The Cryoablation Catheter includes a thermocouple to
measure temperature at its distal portion (freeze zone) for operational status.
The Cryoablation Catheter is delivered to the right upper chamber of the human
heart via common femoral vein cannulation and delivers cold temperatures to
specific heart features in order to ablate targeted tissue. The treatment is
achieved by ablating (or isolating) the arrythmogenic
tissue in contact with distal freeze zone of the catheter. During the
treatment, the tissue in direct contact with the distal freeze zone drops to
cryogenic temperatures resulting in necrosis (ablation) of the tissue.
The design of the Adagio Cryoablation Catheter freeze zone is able to create
linear lesions, providing a greater assurance that the arrythmogenic
tissue/regions are isolated, creating a bidirectional block, which will result
in normal sinus rhythm.
Study burden and risks
RISKS
The use of the investigational device will not expose you to significant
additional risks above the risks of the regular medical care for Atrial Flutter
ablation treatment. The investigational device does not require deviation from
the hospital regular medical care for this type of procedure.
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.
Adagio Medical representatives may be present at the procedure to provide
technical support for both the Adagio Cryoablation System and the study
protocol. There may be side effects that are not known at this time.
Women who are pregnant or nursing a child may not take part in this study.
Before entering the study, you and your study doctor must agree on the method
of birth control you will use during the entire study. If you are fertile, you
will be asked to take a pregnancy test before you will be allowed to
participate in the study. If you think that you have gotten pregnant during the
study, you must tell your study doctor immediately. Pregnant women will be
taken out of the study.
Other Risks
Patient's condition may not get better or may get worse during this study.
BENEFITS
Patient's Atrial Flutter may improve while they are in this study; however,
this cannot be promised. The results of this study may help people with Atrial
Flutter in the future.
26051 Merit Circle, Suite 102 102
Laguna Hills 92653
US
26051 Merit Circle, Suite 102 102
Laguna Hills 92653
US
Listed location countries
Age
Inclusion criteria
Two symptomatic episodes of typical AFl (or chronic atrial flutter) during the one-year period prior to enrollment. This may include typical AFl occurring while receiving AAD therapy for non-AFl tachyarrhythmia, including AFl.
Exclusion criteria
Intra-cardiac thrombus has not been eliminated in subjects exposed to less than 4 weeks of therapeutic anticoagulation and a TEE (trans-esophageal echocardiogram) and/or CT scan did not conclusively rule out thrombus
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 | NL49917.100.14 |