Persistent Atrial Fibrillation
Conditions
Brief summary
Clinical study to evaluate the safety and efficacy of the Adagio AF Cryoablation System (iCLAS™) in the ablation treatment of symptomatic, persistent atrial fibrillation (PsAF). Data will be used to support a pre-market application (PMA)
Detailed description
A staged pre-market, single-arm, clinical study designed to collect acute and long-term safety and efficacy data for the Adagio AF Cryoablation System (iCLAS™). Patient population will consist of symptomatic, persistent AF subjects completing a de novo ablation procedure. Enrollment will be 200 subjects at up to 20 global investigational sites. Subjects will receive an ablation with the ultra-low cryoablation device. Follow-up will include assessment at one, three, six, and twelve months.
Interventions
DEVICEAdagio AF Cryoablation System (iCLAS™)
Endovascular ablation of the left and right atrium
Sponsors
Adagio Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Symptomatic persistent atrial fibrillation that failed at least one class I or Class III AAD with no prior history of ablation
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
IC1 Male or female between the ages of 18 and 80 years IC2 Currently scheduled for an ablation of symptomatic, PsAF defined as continuous AF that is sustained \> 7-days and ≤ 12 months and documented by the following: a. Physician's note indicating continuous AF \> 7 days and ≤ 12 months, AND b. One of the following: i. 24-hour Holter within 180 days of enrollment showing continuous AF, OR ii. Two electrocardiograms from any forms of rhythm monitoring (e.g., 12-lead ECGs or single lead ECGs) completed ≥ 7 days apart within 180 days of enrollment. IC3 Refractory to at least one class I or III AAD. (Refractory defined as not effective, not tolerated or not desired) IC4 Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study IC5 Willingness and ability to give an informed consent
Exclusion criteria
EC 1 In the opinion of the Investigator, any known contraindication to an atrial ablation, TEE, or anticoagulation. Including, but not limited to, the identification of any atrial thrombus or evidence of sepsis EC 2 Any duration of continuous AF lasting longer than 12-months EC 3 History of previous left atrial ablation or surgical treatment for AF/AFL/AT EC 4 Atrial fibrillation secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause EC 5 Structural heart disease as described below: 1. Left ventricular ejection fraction (LVEF) \< 40% based on most recent TTE 2. Left atrial size \> 55 mm (parasternal long axis view) documented within 6-months of screening 3. NYHA Class III or IV heart failure documented within the previous 12-months 4. An implanted pacemaker or ICD 5. Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for CABG), 6. Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve 7. Interatrial baffle, closure device, patch, or PFO occluder 8. Presence of a left atrial appendage occlusion device 9. Presence of any pulmonary vein stenting devices 10. Coronary artery bypass graft (CABG) or PTCA procedure within 6 months prior to procedure 11. Unstable angina or ongoing myocardial ischemia 12. Myocardial infarction within the previous six (6) months prior to procedure 13. Moderate or severe mitral insufficiency or stenosis based on most recent TTE 14. Atrial myxoma 15. Significant congential anomaly EC 6 BMI \> 40 * BMI \>35 and no prior sponsor approval into the study EC 7 Any previous history of cryoglobulinemia EC 8 History of blood clotting or bleeding disease EC 9 History of severe COPD requiring steroid use in the previous 12-months EC 10 History of severe sleep apnea (AHI \> 30) not currently treated with a CPAP machine or other mechanical device EC 11 Any prior history of documented cerebral infarct including recent TIA (within one year) or systemic embolism (excluding a post-operative DVT) EC 12 Any prior history or current evidence of hemidiaphragmatic paralysis EC 13 Pregnant or lactating (current or anticipated during study follow-up) EC 14 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 15 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, terminal illness with a life expectancy of less than two years, extensive travel away from the research center, COVID-19 related concerns)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of the Proportion of Subjects Who Are Free From Device/Procedure Related Major Adverse Events (MAEs) That Occur Following the Cryoablation Procedure | 12-months | Analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the cryoablation procedure. MAEs include any of the following: * Death * Myocardial infarction * Cardiac perforation/pericardial tamponade * Cerebral infarct or systemic embolism * Major bleeding requiring transfusion of blood products * Mitral or tricuspid valve damage * Symptomatic pulmonary vein stenosis * Severe (≥ 70%) pulmonary vein stenosis * Permanent phrenic nerve injury * Access site complications requiring pharmacological or surgical intervention * Atrio-esophageal fistula * Pericarditis * Heart block requiring a permanent pacemaker * Vagal nerve injury with GI dysmotility * Other serious adverse device effects (SADEs), including TIAs, adjudicated by an independent Clinical Events Committee (CEC) as "probably or definitely related" to the Adagio System |
| Analysis of the Proportion of Subjects Receiving a Single Cryoablation Who Are Free From Any Documented Left Atrial Arrhythmia (AF/AFL/AT) Following the Blanking Period Lasting Longer Than 30 Seconds on a Continuous 24-hour ECG Recording (Holter Monitor). | 12-months | Analysis of the proportion of subjects receiving a single cryoablation who are free from any documented left atrial arrhythmia (AF/AFL/AT) following the Blanking Period lasting longer than 30 seconds on a continuous 24-hour ECG recording (Holter monitor). The primary effectiveness endpoint will be based on a centralized core lab interpretation of the recordings used in the endpoint analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of the Proportion of Subjects With Acute Procedural (Ablation) Success | 20-minutes following last ablation | Percentage of patients with documentation of pulmonary vein isolation (LSPV, LIPV, RSPV, RIPV) and posterior wall isolation (PWI) and cavo-tricuspid isthmus (CTI) bidirectional block (BDB) following the last ablation of PV, PW, and CTI. |
Countries
Belgium, Canada, Netherlands, United States
Contacts
PRINCIPAL_INVESTIGATORSuneet Mittal, MD
Valley Hospital
Participant flow
Recruitment details
215 patients were enrolled
Pre-assignment details
189 patients were treated with the investigational device
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 65.5 years STANDARD_DEVIATION 8.4 |
| Left Ventricular Ejection Fraction (LVEF) | 56 % STANDARD_DEVIATION 7.4 |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 139 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 189 |
| other Total, other adverse events | 14 / 189 |
| serious Total, serious adverse events | 10 / 189 |
Outcome results
None listed