Trial Outcomes & Findings for IMPACT: A Safety and Feasibility Study of the IOWA Approach Cardiac Ablation System (NCT NCT03700372)

Last Updated: 2021-10-14

Results Overview

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%)

Recruitment status

COMPLETED

Target enrollment

7 participants

Primary outcome timeframe

30 Days

Results posted on

2021-10-14

Participant Flow

Single Arm Study

Participant milestones

Participant milestones
Measure	IOWA Approach Cardiac Ablation Subjects who are treated with the IOWA Approach Cardiac Ablation System for paroxysmal atrial fibrillation. IOWA Approach Cardiac Ablation System: Epicardial ablation using the IOWA Approach Cardiac Ablation System
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IOWA Approach Cardiac Ablation n=7 Participants Subjects who are treated with the IOWA Approach Cardiac Ablation System for paroxysmal atrial fibrillation. IOWA Approach Cardiac Ablation System: Epicardial ablation using the IOWA Approach Cardiac Ablation System
Age, Continuous	69 Years n=7 Participants
Sex: Female, Male Female	2 Participants n=7 Participants
Sex: Female, Male Male	5 Participants n=7 Participants
Region of Enrollment Czechia	4 participants n=7 Participants
Region of Enrollment France	3 participants n=7 Participants

PRIMARY outcome

Timeframe: 30 Days

Outcome measures

Outcome measures
Measure	IOWA Approach Cardiac Ablation n=7 Participants Subjects who are treated with the IOWA Approach Cardiac Ablation System for paroxysmal atrial fibrillation. IOWA Approach Cardiac Ablation System: Epicardial ablation using the IOWA Approach Cardiac Ablation System
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.	0 Participants

SECONDARY outcome

Timeframe: 1 Day (Acute)

Proportion of subjects that achieve procedural success. Procedural success is defined as the creation of an electrically isolating "box" lesion encompassing the pulmonary veins and posterior left atrium using the study device.

Outcome measures

Outcome measures
Measure	IOWA Approach Cardiac Ablation n=7 Participants Subjects who are treated with the IOWA Approach Cardiac Ablation System for paroxysmal atrial fibrillation. IOWA Approach Cardiac Ablation System: Epicardial ablation using the IOWA Approach Cardiac Ablation System
Feasbility: Electrical Isolation of Posterior Left Atrium and Pulmonary Veins.	6 Participants

Adverse Events

IOWA Approach Cardiac Ablation

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IOWA Approach Cardiac Ablation n=7 participants at risk Subjects who are treated with the IOWA Approach Cardiac Ablation System for paroxysmal atrial fibrillation. IOWA Approach Cardiac Ablation System: Epicardial ablation using the IOWA Approach Cardiac Ablation System
Vascular disorders Hematoma	14.3% 1/7 • Number of events 1 • 1 Year
Cardiac disorders Tachycardia	14.3% 1/7 • Number of events 1 • 1 Year
Cardiac disorders Malaise	14.3% 1/7 • Number of events 1 • 1 Year

Other adverse events

Other adverse events
Measure	IOWA Approach Cardiac Ablation n=7 participants at risk Subjects who are treated with the IOWA Approach Cardiac Ablation System for paroxysmal atrial fibrillation. IOWA Approach Cardiac Ablation System: Epicardial ablation using the IOWA Approach Cardiac Ablation System
Cardiac disorders Paroxysmal Fibrillation	28.6% 2/7 • Number of events 2 • 1 Year
Nervous system disorders Vertigo	14.3% 1/7 • Number of events 1 • 1 Year
Vascular disorders Hypertension	28.6% 2/7 • Number of events 3 • 1 Year
Skin and subcutaneous tissue disorders Pain and redness in the sternotomy area	14.3% 1/7 • Number of events 1 • 1 Year
Vascular disorders Hematoma	14.3% 1/7 • Number of events 1 • 1 Year
Cardiac disorders Atrial tachycardia	28.6% 2/7 • Number of events 2 • 1 Year
Vascular disorders Swelling of lower limbs	42.9% 3/7 • Number of events 3 • 1 Year
Nervous system disorders Dyspnea	28.6% 2/7 • Number of events 3 • 1 Year
Respiratory, thoracic and mediastinal disorders Cough	14.3% 1/7 • Number of events 1 • 1 Year
Vascular disorders Numbness of lower limb	14.3% 1/7 • Number of events 1 • 1 Year
Respiratory, thoracic and mediastinal disorders Tumor in pulmonary region	14.3% 1/7 • Number of events 1 • 1 Year
Vascular disorders Hematuria post-surgery	14.3% 1/7 • Number of events 1 • 1 Year
Cardiac disorders Atrial fibrillation recurrence	14.3% 1/7 • Number of events 1 • 1 Year
Eye disorders Visual disorder	28.6% 2/7 • Number of events 2 • 1 Year
General disorders insomnia	14.3% 1/7 • Number of events 1 • 1 Year
Respiratory, thoracic and mediastinal disorders Bronchitis	14.3% 1/7 • Number of events 1 • 1 Year
General disorders Bloody Spittle	14.3% 1/7 • Number of events 1 • 1 Year
Nervous system disorders Vagal discomfort without loss of consciousness	14.3% 1/7 • Number of events 1 • 1 Year

Additional Information

Christopher (Kit) Schneider Sr. Director of Clinical & Pre-Clinical Engineering

FARAPULSE, Inc.

Phone: 617-686-7661

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place