Paroxysmal Atrial FibrillationIMPACTNCT03700372
IMPACT: A Safety and Feasibility Study of the IOWA Approach Cardiac Ablation System
A study testing IOWA Approach Cardiac Ablation System in people with Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation at 1 site in France.
Trial summary
IMPACT is a prospective, single-arm, multi-center, safety and feasibility study evaluating the IOWA Approach Cardiac 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 Cardiac Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2017to 3 Mar 2021
- 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 who are ≥ 18 and ≤ 70 years of age on the day of enrollment.
- Diagnosis of paroxysmal atrial fibrillation defined as symptomatic paroxysmal AF with at least two episodes of paroxysmal AF observed within the 12 months preceding inclusion.
- Patients are resistant to anti-arrhythmic treatments.
- Anteroposterior 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;
- Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) to be performed including open-heart surgery for one or more of the following:
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- Mitral valve repair or replacement,
- Aortic valve repair or replacement
- Tricuspid valve repair or replacement, or
- Coronary artery bypass procedures
- 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 trial investigators.
- Subject is willing and capable of providing Informed Consent to undergo study procedures and participate in all examinations and follow-ups associated with this clinical trial.
Who cannot join
- Abnormal cardiac and/or epicardial anatomy (such as adhesion, anomalous coronaries, thickened epicardium, etc.) or pericardial reflections on TTE, MRI or CT.
- Prior left-sided cardiac ablation.
- Prior history of open chest surgery and/or any procedure where the pericardial space was entered or instrumented (pericardiocentesis, catheter mapping and /or ablation).
- Patient has a prosthetic heart valve.
- Patient has a left atrial appendage device
- Prior history of pericarditis or pericarditis within 3 months based on the TTE examination.
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- 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 gastrointenstinal 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 (transesophageal echo) or CT
- Implant of pacemaker, ICD (implantable cardioverter defribillator) or CRT (cardiac resynchronization therapy).
- 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.
- Enrolled in another cardiac clinical trial that would interfere with this trial.
- 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.
- Enrolled in another cardiac clinical trial that would interfere with this trial.
Trial locations and contacts
1 site in 1 country.
About this study
IMPACT is a prospective, single-arm, multi-center, safety and feasibility study evaluating the IOWA Approach Cardiac Ablation System (FARAPULSE, Inc.) for the treatment of paroxysmal atrial fibrillation.
Read the detailed description
Patients with paroxysmal atrial fibrillation scheduled to undergo cardiac surgery will be screened for enrollment per protocol inclusion and exclusion criteria. Enrolled patients will then undergo ablation using the IOWA Approach Cardiac Ablation System (FARAPULSE, Inc.), followed by concomitant cardiac surgery. 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 index ablation procedure.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- IOWA Approach Cardiac 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 Cardiac Ablation SystemDevice
Epicardial ablation using the IOWA Approach Cardiac Ablation System
| Study group | Role | What they receive |
|---|---|---|
| IOWA Approach Cardiac Ablation | Experimental | Subjects who are treated with the IOWA Approach Cardiac Ablation System for paroxysmal atrial fibrillation. Receives: Device: IOWA Approach Cardiac Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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%)
Measured: 30 Days
Secondary outcomes (1)
Feasbility: Electrical Isolation of Posterior Left Atrium and Pulmonary Veins.
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.
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 start13 Dec 2017
- Primary completion9 Apr 2019
- Study completion3 Mar 2021
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.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with paroxysmal atrial fibrillation undergoing cardiac surgery and meeting all protocol inclusion/exclusion criteria will be treated with the IOWA Approach Cardiac Ablation System.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700372
- Sponsor's protocol ID
- CS0172
- Acronym
- IMPACT
- Status last verified
- Aug 2021
- First submitted
- 4 Oct 2018
- Last updated
- 14 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT: A Safety and Feasibility Study of the IOWA Approach Cardiac Ablation System
- ClinicalTrials.gov ID
- NCT03700372
- Acronym / sponsor ID
- IMPACT / CS0172
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 9 Apr 2019 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Posted 14 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
IMPACT is a prospective, single-arm, multi-center, safety and feasibility study evaluating the IOWA Approach Cardiac Ablation System (FARAPULSE, Inc.) for the treatment of paroxysmal atrial fibrillation.
Detailed description
Patients with paroxysmal atrial fibrillation scheduled to undergo cardiac surgery will be screened for enrollment per protocol inclusion and exclusion criteria. Enrolled patients will then undergo ablation using the IOWA Approach Cardiac Ablation System (FARAPULSE, Inc.), followed by concomitant cardiac surgery. 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 index 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 with paroxysmal atrial fibrillation undergoing cardiac surgery and meeting all protocol inclusion/exclusion criteria will be treated with the IOWA Approach Cardiac Ablation System.
| Arm | Type | Receives |
|---|---|---|
| IOWA Approach Cardiac Ablation | Experimental | Device: IOWA Approach Cardiac Ablation SystemSubjects who are treated with the IOWA Approach Cardiac 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 (13 listed)
- Patients who are ≥ 18 and ≤ 70 years of age on the day of enrollment.
- Diagnosis of paroxysmal atrial fibrillation defined as symptomatic paroxysmal AF with at least two episodes of paroxysmal AF observed within the 12 months preceding inclusion.
- Patients are resistant to anti-arrhythmic treatments.
- Anteroposterior 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)
- Abnormal cardiac and/or epicardial anatomy (such as adhesion, anomalous coronaries, thickened epicardium, etc.) or pericardial reflections on TTE, MRI or CT.
- Prior left-sided cardiac ablation.
- Prior history of open chest surgery and/or any procedure where the pericardial space was entered or instrumented (pericardiocentesis, catheter mapping and /or ablation).
- Patient has a prosthetic heart valve.
- Patient has a left atrial appendage device
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 Cardiac Ablation SystemEpicardial ablation using the IOWA Approach Cardiac Ablation System | Device | IOWA Approach Cardiac Ablation |
Primary outcome
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.
Time frame: 30 Days
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%)
1 secondary outcome
Feasbility: Electrical Isolation of Posterior Left Atrium and Pulmonary Veins.
Time frame: 1 Day (Acute)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IOWA Approach Cardiac Ablation System in people with Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation at 1 site in France.
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 13 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 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 14 Oct 2021). 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?
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. (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2021.