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

NCT ID: NCT03700385

Last Updated: 2020-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-19
• Study Completion Date: 2020-01-30

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.

Detailed Description

Patients undergoing catheter ablation for paroxysmal atrial fibrillation will be screened for enrollment per protocol inclusion and exclusion criteria. Enrolled patients will then undergo ablation using the IOWA Approach Endocardial Ablation System (FARAPULSE, Inc.). Subjects will be followed at 7 days, 30 days, 3 months, 6 months and 12 months with a blanking period for recurrent atrial fibrillation or atrial tachycardia of 3 months following the PEF catheter ablation procedure.

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IOWA Approach Endocardial Ablation

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

Group Type: EXPERIMENTAL

IOWA Approach Endocardial Ablation System

Intervention Type: DEVICE

Endocardial ablation using the IOWA Approach Endocardial Ablation System

Interventions

IOWA Approach Endocardial Ablation System

Endocardial ablation using the IOWA Approach Endocardial Ablation System

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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.

3. Patients who are ≥ 18 and ≤ 70 years of age on the day of enrollment.

4. 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.

5. Subject has no contraindications to intraoperative transesophageal echocardiography;

6. Left ventricular ejection fraction ≥40% as documented by TTE within 12 months prior to the procedure.

7. Received a standard cardiac work up and is an appropriate candidate for an investigational procedure as determined by study investigators.

8. 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.

Exclusion Criteria

1. Patients on amiodarone at any time during the past 3 months prior to enrollment.

2. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.

3. AF episodes lasting > 7 days.

4. Previous ablation for AF.

5. Patient has a prosthetic heart valve.

6. Patient has a left atrial appendage device

7. Prior history of pericarditis or pericarditis within 3 months based on the TTE examination.

8. Subject is a woman of child bearing age

9. Prior history of rheumatic fever.

10. Prior history of medical procedure involving instrumentation of the left atrium (previous ablation, Atrial septal defect ASD closure, left atrial appendage occlusion)

11. History of severe chronic gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux

12. History of abnormal bleeding and/or clotting disorder.

13. Active malignancy or history of treated cancer within 24 months of enrollment.

14. Clinically significant infection or sepsis.

15. History of stroke or TIA within prior 6 months

16. New York heart Association (NYHA) class IIIb or IV congestive heart failure and/or any heart failure hospitalization within 3 months prior to enrollment.

17. Body mass index > 35.

18. Estimate glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 or has ever received dialysis.

19. History of untreated and serious hypotension, bradycardia or chronotropic incompetence.

20. Any of the following within 3 months of enrollment:

• Major surgery except for the index procedure
• Myocardial infarction
• Unstable angina
• Percutaneous coronary intervention (e.g., CABG or PTCA)
• Sudden cardiac death event
• Left atrial thrombus that has not resolved as shown by TEE or CT
• Implant of pacemaker, ICD or CRT.

21. Solid organ or hematologic transplant, or currently being evaluated for an organ transplant

22. History of pulmonary hypertension with Pulmonary systolic artery pressure >50 mm Hg, severe Chronic Obstructive Pulmonary Disease or restrictive lung disease.

23. Patients with any other significant uncontrolled or unstable medical condition (such as uncontrolled brady-arrhythmias, ventricular arrhythmias, hyperthyroidism or significant coagulation disorder).

24. Life expectancy less than one year.

25. Clinically significant psychological condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements.

26. History of blood clotting or bleeding abnormalities.

27. Contraindication to anticoagulation (i.e., heparin, dabigatran, Vitamin K Antagonists such as warfarin).

28. Enrolled in another cardiac clinical study that would interfere with this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Petr Neuzil, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Nemocnice Na Homolce

Locations

Nemocnice Na Homolce

Prague, , Czechia

CHU Bordeaux

Pessac, , France

Countries

Czechia; France

References

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.

Reference Type: DERIVED

PMID: 31085321 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CS0188

Identifier Type: -

Identifier Source: org_study_id