IMPACT: A Safety and Feasibility Study of the IOWA Approach Cardiac Ablation System

NCT03700372 | Completed Results DMC

• 1 other identifier: CS0172
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

IMPACT is a prospective, single-arm, multi-center, safety and feasibility study evaluating the IOWA Approach Cardiac Ablation System (FARAPULSE, Inc.) for the treatment of paroxysmal atrial fibrillation.

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Primary Safety: A Composite Safety Endpoint Consisting of the Subjects That Experience One or More Serious Adverse Events (SAEs) Related to the Investigational Procedure and/or Device Within 30 Days of the Ablation Procedure or Hospital Discharge.

  A composite safety endpoint consisting of the proportion of subjects that experience one or more of the following serious adverse events (SAEs) related to the investigational procedure and/or device within 30 days of the PEF (pulsed electric field) ablation procedure or hospital discharge, whichever is later, except as noted below: * Cardiac death * Stroke and/or transient ischemic attack (TIA) * Myocardial infarction (MI) * Excessive bleeding * Atrio-esophageal fistula * Persistent post-surgical phrenic nerve paralysis at 12 months * Severe pulmonary vein stenosis (\>70%)

  30 Days

Secondary Outcomes (1)

• Feasbility: Electrical Isolation of Posterior Left Atrium and Pulmonary Veins.

  1 Day (Acute)

Study Arms (1)

IOWA Approach Cardiac Ablation

EXPERIMENTAL

Subjects who are treated with the IOWA Approach Cardiac Ablation System for paroxysmal atrial fibrillation.

Device: IOWA Approach Cardiac Ablation System

Interventions

IOWA Approach Cardiac Ablation System DEVICE

Epicardial ablation using the IOWA Approach Cardiac Ablation System

IOWA Approach Cardiac Ablation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are ≥ 18 and ≤ 70 years of age on the day of enrollment.
• Patients are resistant to anti-arrhythmic treatments.
• Anteroposterior Left atrial diameter ≤ 5.5 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT) within 3 months prior to the procedure.
• Subject has no contraindications to intraoperative transesophageal echocardiography;
• Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) to be performed including open-heart surgery for one or more of the following:
• Mitral valve repair or replacement,
• Aortic valve repair or replacement
• Tricuspid valve repair or replacement, or
• Coronary artery bypass procedures
• Left ventricular ejection fraction ≥40% as documented by TTE within 12 months prior to the procedure.
• Received a standard cardiac work up and is an appropriate candidate for an investigational procedure as determined by trial investigators.
• Subject is willing and capable of providing Informed Consent to undergo study procedures and participate in all examinations and follow-ups associated with this clinical trial.

You may not qualify if:

• Abnormal cardiac and/or epicardial anatomy (such as adhesion, anomalous coronaries, thickened epicardium, etc.) or pericardial reflections on TTE, MRI or CT.
• Prior left-sided cardiac ablation.
• Prior history of open chest surgery and/or any procedure where the pericardial space was entered or instrumented (pericardiocentesis, catheter mapping and /or ablation).
• Patient has a prosthetic heart valve.
• Patient has a left atrial appendage device
• Prior history of pericarditis or pericarditis within 3 months based on the TTE examination.
• Subject is a woman of child bearing age
• Prior history of rheumatic fever.
• Prior history of medical procedure involving instrumentation of the left atrium (previous ablation, Atrial septal defect) ASD closure, left atrial appendage occlusion)
• History of severe chronic gastrointenstinal problems involving the esophagus, stomach and/or untreated acid reflux
• History of abnormal bleeding and/or clotting disorder.
• Active malignancy or history of treated cancer within 24 months of enrollment.
• Clinically significant infection or sepsis.
• History of stroke or TIA within prior 6 months
• New York heart Association (NYHA) class IIIb or IV congestive heart failure and/or any heart failure hospitalization within 3 months prior to enrollment.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

CHU Bordeaux

Pessac, 33604, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Christopher (Kit) Schneider Sr. Director of Clinical & Pre-Clinical Engineering
• Organization: FARAPULSE, Inc.

cschneider@farapulse.com

617-686-7661

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients with paroxysmal atrial fibrillation undergoing cardiac surgery and meeting all protocol inclusion/exclusion criteria will be treated with the IOWA Approach Cardiac Ablation System.

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 9, 2018
• Study Start: December 13, 2017
• Primary Completion: April 9, 2019
• Study Completion: March 3, 2021
• Last Updated: October 14, 2021
• Results First Posted: October 14, 2021

Record last verified: 2021-08

Locations

FR (1)