The objective of this clinical study is to evaluate the safety and performance of the Adagio VT Cryoablation System in the ablation treatment of Monomorphic VT
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The Primary Endpoint for Safety is an analysis of the proportion of subjects
who are free from definite or probable device/procedure related Major Adverse
Events (MAEs) that occur during or within 30 days following the cryoablation
procedure.
The Primary Endpoint for Clinical Performance is an analysis of the proportion
of patients receiving a single cryoablation procedure with freedom from
ventricular tachycardia lasting longer than 30 seconds or appropriate ICD
intervention until the end of the 6 month follow up period.
The Primary Endpoint for Procedure Performance is an analysis of the proportion
of subjects with non-inducible clinical monomorphic VT at the conclusion of the
initial cryoablation procedure.
Secondary outcome
Safety
- The proportion of study subjects with probable or definite device or
procedure related serious adverse events (SAEs) including MAEs as described
above, or serious adverse device effects (SADEs) between 30-days and up to 12
months post-procedure.
Events will be adjudicated by an independent Data and Safety Monitoring Board
(DSMB) for relatedness to the Adagio System.
Performance
- The proportion of study subjects with non-inducible sustained monomorphic VT
at the end of the ablation procedure
- The proportion of study subjects with freedom from Ventricular Tachycardia
lasting longer than 30 seconds at 12 months without the use of anti-arrhythmic
drugs (AADs)
- The proportion of study subjects with freedom from Ventricular Tachycardia
lasting longer than 30 seconds at 12 months with previously failed AADs
- Reduction of VT burden at 6 and 12 months
Descriptive Statistics
- Procedure fluoroscopy time
- Total ablation time
- Total procedure time
- Number and location of cryoablation lesions
- Number of inducible clinical VTs before and after cryoablation
- Number of appropriate and inappropriate ICD therapies (shocks and
antitachycardia pacing, ATP) in the follow up period
- Mapping and ablation strategies utilized during the ablation procedure
- Freedom from cardiovascular (CV) hospitalizations or CV-related ER visits
through 12 months
- Recording of the use of AADs in the follow up period
Background summary
Ventricular tachycardia may impair cardiac output with consequent hypotension,
collapse, and acute cardiac failure. The presence of pre-existing poor
ventricular function is strongly associated with cardiovascular compromise.
The field of catheter ablation has progressed with the development of new
methods and tools, and with the publication of large clinical trials. The HRS
document was used to develop this protocol and to provide the best possible
outcomes for patients with ventricular arrhythmias. Catheter ablation has an
important role in reducing or preventing VAs both in patients with heart
disease and in those with idiopathic VTs. Once the substrate is identified, one
needs an ablation source that can provide enough energy to eradicate the source
of the VT. The literature shows that ventricular tachycardia ablation has
proven safe and viable for most VT.
Catheter radiofrequency ablation of VT originating from the left ventricle*s
papillary muscles has been linked to conflicting outcomes. Cryoablation was
correlated with greater success rates and smaller recurrence rates than
radiofrequency procedures, superior catheter support, and smaller frequency of
polymorphic arrhythmias.
Cryoablation is a process that uses extreme cold to destroy tissue.
Historically cryo in the cardiac ablation space has been used for atrial
fibrillation. Adagio Medical has a history of developing cryo technology for
persistent Atrial fibrillation with CE mark approval obtained in June 2020.
Adagio Medical has also designed a VT catheter to prove intramural lesions for
monomorphic VT
Study objective
The objective of this clinical study is to evaluate the safety and performance
of the Adagio VT Cryoablation System in the ablation treatment of Monomorphic
VT
Study design
A prospective, single-arm, multi-center, pre-market, clinical study designed to
provide safety and performance data regarding the use of the Adagio Medical VT
Cryoablation System in the treatment of ventricular tachycardia.
Intervention
A VT ablation procedure is performed by finding the abnormal ventricular heart
tissue that is causing the VT and applying energy with an ablation catheter to
the area. The goal is to apply energy to create a scar or destroy the tissue
that causes the VT, such that VT is no longer present or inducible.
Study burden and risks
Not applicable with this protocol
26051 Merit Circle Suite 102
Laguna Hills 92653
US
26051 Merit Circle Suite 102
Laguna Hills 92653
US
Listed location countries
Age
Inclusion criteria
IC 1 Male or female the ages of >= 18 years
IC 2 Eligible for a catheter ablation due to Ischemic and/or non-ischemic
recurrent symptomatic sustained monomorphic Ventricular Tachycardia also
defined as having a similar QRS configuration from beat to beat.
IC 3 Has or will be receiving an ICD prior to hospital discharge post procedure.
IC 4 Refractory to at least one AAD (Refractory is defined as an AAD not able
to treat the arrhythmia satisfactorily or induces unwanted side effects).
IC 5 Subject has LVEF > 20%, confirmed by echo or comparable technique in the
previous 3 months or during baseline evaluation
IC 6 Willingness, ability, and commitment to participate in baseline and
follow-up evaluations for the full length of the study
IC 7 Willingness and ability to give an informed consent
Exclusion criteria
EC 1 Any known objective contraindication to ventricular tachycardia ablation,
TEE, or anticoagulation, including but not limited to the identification of any
cardiac thrombus or evidence of sepsis
EC 2 Any duration of continuous arrythmia that is not monomorphic ventricular
tachycardia. Multiple monomorphic tachycardia is acceptable, but polymorphic VT
is not.
EC 3 Any VT ablation within 4 weeks prior to enrollment
EC 4 More than one prior (>4 weeks) Ventricular Tachycardia ablation or prior
surgical treatment for ventricular tachycardia
EC 5 Ventricular tachycardia secondary to electrolyte imbalance, active thyroid
disease, or any other reversible or non-cardiac cause
EC 6 Structural heart disease as described below:
a. Class IV heart failure
b. Aortic aneurysm
c. Previous cardiac surgery or percutaneous coronary intervention within 60
days prior to the procedure
d. Interatrial baffle, closure device, patch, or PFO occlusion device
e. IVC filter
f. Coronary artery bypass graft (CABG) procedure within six (6) months prior
to the ablation procedure
g. Severe Mitral or Aortic insufficiency or stenosis based on most recent TTE
h. Cardiac myxoma
i. Significant congenital anomaly
j. Recent Myocardial Infarct (MI) or unstable angina, within 60 days prior to
the ablation procedure
k. Mechanical aortic or mitral valve
EC 7 Any previous history of cryoglobulinemia
EC 8 History of blood clotting or bleeding disease
EC 9 Any prior history of documented cerebral vascular accident (CVA), TIA or
systemic embolism (excluding a post-operative Deep Vein Thrombosis, DVT),
within 6 months prior to the ablation procedure.
EC 10 Breastfeeding, pregnant, or anticipated pregnancy 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
patient a poor candidate for this procedure, the study or compliance with the
protocol (includes vulnerable patient population, mental illness, addictive
disease, candidate for heart transplantation, patient with ventricular assist
device, or terminal illness with a life expectancy less than 12 months)
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 | NL76264.100.20 |