Paroxysmal Atrial FibrillationNCT03700385
IMPULSE: A Safety and Feasibility Study of the IOWA Approach Endocardial Ablation System to Treat Atrial Fibrillation
A study testing IOWA Approach Endocardial Ablation System in people with Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- IOWA Approach Endocardial Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 19 Jan 2018to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
- Patients who are ≥ 18 and ≤ 70 years of age on the day of enrollment.
- 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.
- Subject has no contraindications to intraoperative transesophageal echocardiography;
- Left ventricular ejection fraction ≥40% as documented by TTE within 12 months prior to the procedure.
- Received a standard cardiac work up and is an appropriate candidate for an investigational procedure as determined by study investigators.
- 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.
Who cannot join
- Patients on amiodarone at any time during the past 3 months prior to enrollment.
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- AF episodes lasting > 7 days.
- Previous ablation for AF.
- Patient has a prosthetic heart valve.
- Patient has a left atrial appendage device
Show all 35Show fewer
- Prior history of pericarditis or pericarditis within 3 months based on the TTE examination.
- Subject is a woman of child bearing age
- Prior history of rheumatic fever.
- Prior history of medical procedure involving instrumentation of the left atrium (previous ablation, Atrial septal defect ASD closure, left atrial appendage occlusion)
- History of severe chronic gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux
- History of abnormal bleeding and/or clotting disorder.
- Active malignancy or history of treated cancer within 24 months of enrollment.
- Clinically significant infection or sepsis.
- History of stroke or TIA within prior 6 months
- New York heart Association (NYHA) class IIIb or IV congestive heart failure and/or any heart failure hospitalization within 3 months prior to enrollment.
- Body mass index > 35.
- Estimate glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 or has ever received dialysis.
- History of untreated and serious hypotension, bradycardia or chronotropic incompetence.
- 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.
- Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
- History of pulmonary hypertension with Pulmonary systolic artery pressure >50 mm Hg, severe Chronic Obstructive Pulmonary Disease or restrictive lung disease.
- Patients with any other significant uncontrolled or unstable medical condition (such as uncontrolled brady-arrhythmias, ventricular arrhythmias, hyperthyroidism or significant coagulation disorder).
- Life expectancy less than one year.
- Clinically significant psychological condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements.
- History of blood clotting or bleeding abnormalities.
- Contraindication to anticoagulation (i.e., heparin, dabigatran, Vitamin K Antagonists such as warfarin).
- Enrolled in another cardiac clinical study that would interfere with this study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: The IMPULSE Study: A Safety and Feasibility Study of the IOWA Approach Endocardial Ablation System to Treat Atrial Fibrillation
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.
Read the 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
- Being tested
- IOWA Approach Endocardial Ablation System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOWA Approach Endocardial Ablation SystemDevice
Endocardial ablation using the IOWA Approach Endocardial Ablation System
| Study group | Role | What they receive |
|---|---|---|
| IOWA Approach Endocardial Ablation | Experimental | Subjects who are treated with the IOWA Approach Endocardial Ablation System for paroxysmal atrial fibrillation. Receives: Device: IOWA Approach Endocardial Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
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.
Measured: 7 days
Feasibility: Number of Patients With Pulmonary Vein Isolation
Percentage of subjects achieving pulmonary vein isolation using the IOWA Approach Endocardial Ablation System.
Measured: 1 Day (Acute)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start19 Jan 2018
- Primary completion21 Dec 2018
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Petr Neuzil, MD, PhD, Principal investigator, Nemocnice Na Homolce
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700385
- Sponsor's protocol ID
- CS0188
- Status last verified
- Sep 2020
- First submitted
- 4 Oct 2018
- Last updated
- 23 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 31085321
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The IMPULSE Study: A Safety and Feasibility Study of the IOWA Approach Endocardial Ablation System to Treat Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03700385
- Acronym / sponsor ID
- CS0188
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Posted 23 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| IOWA Approach Endocardial Ablation | Experimental | Device: IOWA Approach Endocardial Ablation SystemSubjects who are treated with the IOWA Approach Endocardial Ablation System for paroxysmal atrial fibrillation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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.
- Patients who are ≥ 18 and ≤ 70 years of age on the day of enrollment.
- 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.
- Subject has no contraindications to intraoperative transesophageal echocardiography;
Key exclusion criteria (35 listed)
- Patients on amiodarone at any time during the past 3 months prior to enrollment.
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- AF episodes lasting > 7 days.
- Previous ablation for AF.
- Patient has a prosthetic heart valve.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IOWA Approach Endocardial Ablation SystemEndocardial ablation using the IOWA Approach Endocardial Ablation System | Device | IOWA Approach Endocardial Ablation |
Primary outcome
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).
Time frame: 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.
Feasibility: Number of Patients With Pulmonary Vein Isolation
Time frame: 1 Day (Acute)
Percentage of subjects achieving pulmonary vein isolation using the IOWA Approach Endocardial Ablation System.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31085321Reddy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Neuzil, MD, PhD principal investigator
Nemocnice Na Homolce
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IOWA Approach Endocardial Ablation System in people with Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03700385, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2020.