Trial Outcomes & Findings for IMPULSE: A Safety and Feasibility Study of the IOWA Approach Endocardial Ablation System to Treat Atrial Fibrillation (NCT NCT03700385)

NCT ID: NCT03700385

Last Updated: 2020-09-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2020-09-23

Participant Flow

A total of 40 subjects consented and were treated.

A total of 40 patients were enrolled (signed informed consent) and 40 subjects were treated at two (2) sites in Europe.

Participant milestones

Measure	IOWA Approach Endocardial Ablation Subjects who are treated with the IOWA Approach Endocardial Ablation System for paroxysmal atrial fibrillation. IOWA Approach Endocardial Ablation System: Endocardial ablation using the IOWA Approach Endocardial Ablation System
Overall Study STARTED	40
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	IOWA Approach Endocardial Ablation Subjects who are treated with the IOWA Approach Endocardial Ablation System for paroxysmal atrial fibrillation. IOWA Approach Endocardial Ablation System: Endocardial ablation using the IOWA Approach Endocardial Ablation System
Overall Study Lost to Follow-up	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	IOWA Approach Endocardial Ablation n=40 Participants Subjects who are treated with the IOWA Approach Endocardial Ablation System for paroxysmal atrial fibrillation. IOWA Approach Endocardial Ablation System: Endocardial ablation using the IOWA Approach Endocardial Ablation System
Age, Continuous	58.2 Years STANDARD_DEVIATION 9.1 • n=40 Participants
Sex: Female, Male Female	12 Participants n=40 Participants
Sex: Female, Male Male	28 Participants n=40 Participants
Region of Enrollment Czechia	30 participants n=40 Participants
Region of Enrollment France	10 participants n=40 Participants

PRIMARY outcome

Timeframe: 7 days

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.

Outcome measures

Measure	IOWA Approach Endocardial Ablation n=40 Participants Subjects who are treated with the IOWA Approach Endocardial Ablation System for paroxysmal atrial fibrillation. IOWA Approach Endocardial Ablation System: Endocardial ablation using the IOWA Approach Endocardial Ablation System
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).	2.5 percentage of participants

PRIMARY outcome

Timeframe: 1 Day (Acute)

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

Outcome measures

Measure	IOWA Approach Endocardial Ablation n=40 Participants Subjects who are treated with the IOWA Approach Endocardial Ablation System for paroxysmal atrial fibrillation. IOWA Approach Endocardial Ablation System: Endocardial ablation using the IOWA Approach Endocardial Ablation System
Feasibility: Number of Patients With Pulmonary Vein Isolation	40 Participants

Adverse Events

IOWA Approach Endocardial Ablation

Serious events: 7 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	IOWA Approach Endocardial Ablation n=40 participants at risk Subjects who are treated with the IOWA Approach Endocardial Ablation System for paroxysmal atrial fibrillation. IOWA Approach Endocardial Ablation System: Endocardial ablation using the IOWA Approach Endocardial Ablation System
Cardiac disorders Atrial Fibrillation	5.0% 2/40 • Number of events 2 • 1 year
Cardiac disorders Atrial Tachycardia	5.0% 2/40 • Number of events 2 • 1 year
Cardiac disorders Cardiac Tamponade	2.5% 1/40 • Number of events 1 • 1 year
Renal and urinary disorders Calculus Urinary	2.5% 1/40 • Number of events 1 • 1 year
Vascular disorders Arteriovenous Fistula	2.5% 1/40 • Number of events 1 • 1 year

Other adverse events

Measure	IOWA Approach Endocardial Ablation n=40 participants at risk Subjects who are treated with the IOWA Approach Endocardial Ablation System for paroxysmal atrial fibrillation. IOWA Approach Endocardial Ablation System: Endocardial ablation using the IOWA Approach Endocardial Ablation System
Cardiac disorders Atrial Fibrillation	10.0% 4/40 • Number of events 4 • 1 year
Musculoskeletal and connective tissue disorders Back Pain	7.5% 3/40 • Number of events 3 • 1 year

Additional Information

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

FARAPULSE, Inc.

Phone: 617-686-7661

Email: kschneider@farapulse.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place