IMPULSE: A Safety and Feasibility Study of the IOWA Approach Endocardial Ablation System to Treat Atrial Fibrillation

NCT03700385 | Completed Results DMC FDA Device

• 1 other identifier: CS0188
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• The Primary Safety Endpoint for This Study is the Incidence of Early-onset (Within 7 Days of the PEF Ablation Procedure) Primary Adverse Events (AEs).

  The primary safety endpoint for this study is the incidence of early-onset (within 7 days of the PEF ablation procedure) primary adverse events (AEs). * Death * Myocardial infarction (MI) * Pulmonary vein (PV) stenosis† * Diaphragmatic paralysis * Atrio-esophageal fistula† * Transient Ischemic Attack (TIA) * Stroke/Cerebrovascular accident (CVA) Thromboembolism * Pericarditis requiring intervention (major) * Cardiac Tamponade/Perforation * Pneumothorax * Vascular Access Complications * Pulmonary edema * Hospitalization (initial and prolonged)\* * Heart block * Excludes hospitalization (initial \& prolonged) solely due to arrhythmia (AF/Atrial Flutter/Atrial Tachycardia) recurrence or due to non-urgent cardioversion (pharmacological or electrical). * Pulmonary vein (PV) stenosis or atrio-esophageal fistula that occurs greater than one week (7 days) post-procedure shall be deemed a Primary AE.

  7 days

• Feasibility: Number of Patients With Pulmonary Vein Isolation

  Percentage of subjects achieving pulmonary vein isolation using the IOWA Approach Endocardial Ablation System.

  1 Day (Acute)

Study Arms (1)

IOWA Approach Endocardial Ablation

EXPERIMENTAL

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

Device: IOWA Approach Endocardial Ablation System

Interventions

IOWA Approach Endocardial Ablation System DEVICE

Endocardial ablation using the IOWA Approach Endocardial Ablation System

IOWA Approach Endocardial 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 with PAF who have had at least one AF episode documented within one (1) year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.
• Patients who have failed at least one antiarrhythmic drug (AAD; class I or III, or AV nodal blocking agents such as beta blockers and calcium channel blockers) as shown by recurrent symptomatic AF, or intolerance to the AAD or AV nodal blocking agents.
• Patients who are ≥ 18 and ≤ 70 years of age on the day of enrollment.
• Antero-posterior 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;
• 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 study investigators.
• Subject is willing and capable of providing Informed Consent to undergo study procedures and participate in all examinations and follow-up visits and tests associated with this clinical study.

You may not qualify if:

• Patients on amiodarone at any time during the past 3 months prior to enrollment.
• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
• AF episodes lasting \> 7 days.
• Previous ablation for AF.
• 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 gastrointestinal 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (2)

Nemocnice Na Homolce

Prague, Czechia

Location

CHU Bordeaux

Pessac, 33604, France

Location

Related Publications (1)

• Reddy VY, Neuzil P, Koruth JS, Petru J, Funosako M, Cochet H, Sediva L, Chovanec M, Dukkipati SR, Jais P. Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation. J Am Coll Cardiol. 2019 Jul 23;74(3):315-326. doi: 10.1016/j.jacc.2019.04.021. Epub 2019 May 11.

  PMID: 31085321 DERIVED

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.

kschneider@farapulse.com

617-686-7661

Study Officials

• Petr Neuzil, MD, PhD

  Nemocnice Na Homolce

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Model Details: Patients undergoing catheter ablation of paroxysmal atrial fibrillation and meeting all protocol inclusion/exclusion criteria will be treated with the IOWA Approach Endocardial Ablation System.

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 9, 2018
• Study Start: January 19, 2018
• Primary Completion: December 21, 2018
• Study Completion: January 30, 2020
• Last Updated: September 23, 2020
• Results First Posted: September 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); FR (1)