IMPULSE: A Safety and Feasibility Study of the IOWA Approach Endocardial Ablation System to Treat Atrial Fibrillation
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ClinicalTrials.gov Identifier: NCT03700385 |
Recruitment Status :
Completed
First Posted : October 9, 2018
Results First Posted : September 23, 2020
Last Update Posted : September 23, 2020
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Sponsor:
Farapulse, Inc.
Information provided by (Responsible Party):
Farapulse, Inc.
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Tracking Information | |||||||||
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First Submitted Date ICMJE | October 4, 2018 | ||||||||
First Posted Date ICMJE | October 9, 2018 | ||||||||
Results First Submitted Date ICMJE | August 15, 2020 | ||||||||
Results First Posted Date ICMJE | September 23, 2020 | ||||||||
Last Update Posted Date | September 23, 2020 | ||||||||
Actual Study Start Date ICMJE | January 19, 2018 | ||||||||
Actual Primary Completion Date | December 21, 2018 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | IMPULSE: A Safety and Feasibility Study of the IOWA Approach Endocardial Ablation System to Treat Atrial Fibrillation | ||||||||
Official Title ICMJE | The IMPULSE Study: A Safety and Feasibility Study of the IOWA Approach Endocardial Ablation System to Treat Atrial Fibrillation | ||||||||
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. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: 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. Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Paroxysmal Atrial Fibrillation | ||||||||
Intervention ICMJE | Device: IOWA Approach Endocardial Ablation System
Endocardial ablation using the IOWA Approach Endocardial Ablation System
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Study Arms ICMJE | Experimental: IOWA Approach Endocardial Ablation
Subjects who are treated with the IOWA Approach Endocardial Ablation System for paroxysmal atrial fibrillation.
Intervention: Device: IOWA Approach Endocardial Ablation System
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Publications * | 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. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Completed | ||||||||
Actual Enrollment ICMJE |
40 | ||||||||
Original Enrollment ICMJE | Not Provided | ||||||||
Actual Study Completion Date ICMJE | January 30, 2020 | ||||||||
Actual Primary Completion Date | December 21, 2018 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Listed Location Countries ICMJE | Czechia, France | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03700385 | ||||||||
Other Study ID Numbers ICMJE | CS0188 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Farapulse, Inc. | ||||||||
Original Responsible Party | [Redacted] | ||||||||
Current Study Sponsor ICMJE | Farapulse, Inc. | ||||||||
Original Study Sponsor ICMJE | [Redacted] | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Farapulse, Inc. | ||||||||
Verification Date | September 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |