Investigation of the Adagio Cryoablation System in Patients With Atrial Fibrillation

NCT02839304 | Completed DMC

• 1 other identifier: CS-029
• Study Type: interventional
• Target: 80
• Locations: 3 countries
• Sites: 3

Brief Summary

The objective of the study is to demonstrate the safety and feasibility of the Adagio Cryoablation System is subjects with Paroxysmal (PAF), Persistent (PsAF) and Long-Standing Persistent Atrial Fibrillation.

Conditions

Atrial Fibrillation; Atrial Flutter

Outcome Measures

Primary Outcomes (7)

• The primary safety endpoint will be determined by evaluating the incidence of procedural adverse events.

  1 day

• The primary safety endpoint will be determined by evaluating the incidence of serious adverse events within 7 days of procedure

  7 days

• The primary safety endpoint will be determined by evaluating the incidence of serious adverse events > 7 days after the procedure

  30 days

• The primary safety endpoint will be determined by evaluating the incidence of serious adverse events > 30 days after the procedure

  12 months

• Technical performance assessed by complete electrical isolation of all pulmonary veins (entrance block).

  1 day

• Technical performance assessed by AF termination targeting driver regions, when applicable

  1 day

• Technical performance assessed by complete linear block of linear lesions if deployed

  1 day

Secondary Outcomes (5)

• Performance assessed by percentage of RF focal ablation (touch up) to reach the primary performance endpoint.

  1 day

• Performance assessed by procedural fluoroscopy times

  1 day

• Performance assessed by ablation times

  1 day

• Performance assessed by total procedure times)

  1 day

• Performance assessed by complete freedom from documented AF or other atrial tachycardia (>30s), using a Holter monitor at 6-, 9-, and 12 months post ablation, after a single procedure and off AAD (following a 3 month blanking period).

  12 months

Study Arms (1)

Catheter Ablation Treatment

EXPERIMENTAL

Cryoablation System: Atrial Fibrillation Ablation

Device: Cryoablation System

Interventions

Cryoablation System DEVICE

Pulmonary Vein Isolation, Posterior Wall Isolation. May Include Mitral Line ablation, AF Driver ablation, and Cavo-tricuspid Isthmus ablation as indicated

Catheter Ablation Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is diagnosed with paroxysmal (PAF), persistent, or long standing persistent atrial fibrillation (PsAF) 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.
• Reported incidence of at least one (1) documented episode of symptomatic atrial fibrillation (AF) during the twelve months preceding trial entry (should be documented by rhythm strip or ECG).
• Failure of at least one anti-arrhythmic medication (AAD) for paroxysmal atrial fibrillation \[class I or III, or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)\] as evidenced by recurrent symptomatic paroxysmal atrial fibrillation, or intolerable side effects due to AAD.
• Left atrial size \<55 mm in largest dimension as measured and image documented by preoperative imaging (CT, MRI and/or TTE)
• Left Ventricular Ejection Fraction ≥ 40% (obtained within 12 months prior to the procedure).
• Anticoagulation therapy: patient is receiving anticoagulation therapy four (4) weeks prior to the ablation procedure (where appropriate) according to 2014 AHA/ACC/HRS Guideline for the Management of Patients with Atrial Fibrillation.
• Patient is at least 18 and ≤80 years of age.
• Patient is able and willing to comply with mandatory pre and post follow-up testing.
• Patient is able and willing to give informed consent.

You may not qualify if:

• Patient had any previous left atrial ablation.
• History of any valvular cardiac surgical procedure, atrial septal defect closure device; or left atrial appendage closure device.
• Coronary artery bypass grafting (CABG) procedure within the last 3 months.
• Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
• 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.
• History of a documented thromboembolic event within the past one (1) year.
• Diagnosed atrial myxoma.
• Patient has defibrillator implant.
• Patient has known cryoglobulinemia.
• Patient has any contraindication for oral anticoagulation.
• Anaphylactic allergy to contrast media.
• Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
• Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
• Acute illness or active systemic infection or sepsis.
• Unstable angina.

Sponsors & Collaborators

• Adagio Medical: lead

Study Sites (3)

OLV Hospital

Aalst, 9300, Belgium

Location

Cardiology Hospital of Haut-Lévêque

Pessac, 33600, France

Location

St. Antonius Hospital

Nieuwegein, Netherlands

Location

Related Publications (1)

• Klaver MN, De Potter TJR, Iliodromitis K, Babkin A, Cabrita D, Fabbricatore D, Boersma LVA. Ultralow temperature cryoablation using near-critical nitrogen for cavotricuspid isthmus-ablation, first-in-human results. J Cardiovasc Electrophysiol. 2021 Aug;32(8):2025-2032. doi: 10.1111/jce.15142. Epub 2021 Jul 9.

  PMID: 34196991 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 20, 2016
• Study Start: July 1, 2016
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2021
• Last Updated: September 20, 2021

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); FR (1); NL (1)