A Prospective, Multicenter Investigation of the Adagio Cryoablation System in Patients With Atrial Fibrillation

Status: Completed
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: No
View:

• 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.

Locations
Other Locations
Belgium
OLV Hospital
Aalst
France
Cardiology Hospital of Haut-Lévêque
Pessac
Netherlands
St. Antonius Hospital
Nieuwegein,
Time Frame
Start Date: July 2016
Completion Date: March 31, 2021
Participants
Target number of participants: 80
Treatments
Experimental: Catheter Ablation Treatment
Cryoablation System: Atrial Fibrillation Ablation
Related Therapeutic Areas
Sponsors
Leads: Adagio Medical

This content was sourced from clinicaltrials.gov

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