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

• ClinicalTrials.gov Identifier: NCT03700385
• Recruitment Status: Completed
• First Posted: October 9, 2018
• Results First Posted: September 23, 2020
• Last Update Posted: September 23, 2020
• Sponsor: Farapulse, Inc.
• Information provided by (Responsible Party): Farapulse, Inc.

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Paroxysmal Atrial Fibrillation
• Intervention: Device: IOWA Approach Endocardial Ablation System
• Enrollment: 40

Participant Flow

Recruitment Details	A total of 40 subjects consented and were treated.
Pre-assignment Details	A total of 40 patients were enrolled (signed informed consent) and 40 subjects were treated at two (2) sites in Europe.

Arm/Group Title	IOWA Approach Endocardial Ablation
Arm/Group Description	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
Period Title: Overall Study
Started	40
Completed	39
Not Completed	1
Reason Not Completed
Lost to Follow-up	1

Baseline Characteristics

Arm/Group Title		IOWA Approach Endocardial Ablation
Arm/Group Description		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 Number of Baseline Participants		40
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	40 participants
		58.2 (9.1)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	40 participants
	Female	12 30.0%
	Male	28 70.0%
Race and Ethnicity Not Collected [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Czechia	Number Analyzed	40 participants
		30
France	Number Analyzed	40 participants
		10

Outcome Measures

1. Primary Outcome

Title	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).
Description	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.
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IOWA Approach Endocardial Ablation
Arm/Group Description:	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 Number of Participants Analyzed	40
Measure Type: Number; Unit of Measure: percentage of participants
	2.5

2. Primary Outcome

Title	Feasibility: Number of Patients With Pulmonary Vein Isolation
Description	Percentage of subjects achieving pulmonary vein isolation using the IOWA Approach Endocardial Ablation System.
Time Frame	1 Day (Acute)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IOWA Approach Endocardial Ablation
Arm/Group Description:	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 Number of Participants Analyzed	40
Measure Type: Count of Participants; Unit of Measure: Participants
	40 100.0%

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	IOWA Approach Endocardial Ablation
Arm/Group Description	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
All-Cause Mortality
	IOWA Approach Endocardial Ablation
	Affected / at Risk (%)
Total	0/40 (0.00%)
Serious Adverse Events
	IOWA Approach Endocardial Ablation
	Affected / at Risk (%)	# Events
Total	7/40 (17.50%)
Cardiac disorders
Atrial Fibrillation †	2/40 (5.00%)	2
Atrial Tachycardia †	2/40 (5.00%)	2
Cardiac Tamponade †	1/40 (2.50%)	1
Renal and urinary disorders
Calculus Urinary †	1/40 (2.50%)	1
Vascular disorders
Arteriovenous Fistula †	1/40 (2.50%)	1
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	IOWA Approach Endocardial Ablation
	Affected / at Risk (%)	# Events
Total	7/40 (17.50%)
Cardiac disorders
Atrial Fibrillation †	4/40 (10.00%)	4
Musculoskeletal and connective tissue disorders
Back Pain †	3/40 (7.50%)	3
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Christopher (Kit) Schneider Sr. Director of Clinical & Pre-Clinical Engineering
• Organization: FARAPULSE, Inc.
• Phone: 617-686-7661
• EMail: kschneider@farapulse.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Farapulse, Inc.
• ClinicalTrials.gov Identifier: NCT03700385
• Other Study ID Numbers: CS0188
• First Submitted: October 4, 2018
• First Posted: October 9, 2018
• Results First Submitted: August 15, 2020
• Results First Posted: September 23, 2020
• Last Update Posted: September 23, 2020