- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05115214
Safety and Performance of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation (SpherePVI)
A Safety and Performance Assessment of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sandra Jacobs
- Phone Number: +31433566609
- Email: sandra.jacobs@medtronic.com
Study Locations
-
-
-
Prague, Czechia
- Recruiting
- Homolka Hospital
-
Contact:
- Petr Neužil, MD. PhD
-
Praha, Czechia
- Recruiting
- Institute Klinicke a Experimentalni Mediciny
-
Contact:
- Petr Peichl, MD. PhD.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Symptomatic paroxysmal atrial fibrillation (PAF) documented by:
- A physician's note indicating recurrent, self-terminating AF
- At least two electrocardiographically documented AF episodes within 12 months prior to enrollment
- Failure or intolerance of at least one Class I-IV anti-arrhythmic drug.
- Suitable candidate for catheter ablation.
- Age ≥ 18 and < 75 years.
- Able and willing to give informed consent.
- Able and willing, and has ample means to comply with all pre-procedure, post-procedure and follow-up testing requirements.
Exclusion Criteria:
- Continuous AF lasting more than 7 days.
- AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or reversible or non-cardiac cause.
- Previous left atrial catheter or surgical ablation (including septal closure or left atrial appendage closure)
- Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
- Any carotid stenting or endarterectomy.
- Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within 90 days prior to the initial procedure.
- Coronary artery bypass graft (CABG) procedure within the 6 months prior to the index ablation procedure.
- Awaiting cardiac transplantation or other cardiac surgery within 12 months following the initial ablation procedure.
- Presence of any type of implantable cardiac defibrillator (with or without biventricular pacing function).
- Documented thromboembolic event (stroke or transient ischemic attack) within the past 6 months (180 days).
- Documented left atrial thrombus on imaging.
- History of blood clotting or bleeding abnormalities.
- Any condition contraindicating chronic anticoagulation.
- Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure.
- Body mass index >40 kg/m2.
- Left atrial diameter >50 mm (anteroposterior).
- Diagnosed atrial myxoma.
- Left ventricular ejection fraction (EF) < 40%.
- Uncontrolled heart failure or NYHA Class III or IV heart failure.
- Rheumatic heart disease.
- Hypertrophic cardiomyopathy.
- Unstable angina.
- Moderate to severe mitral valve stenosis.
Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2
).
- Primary pulmonary hypertension.
- Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
- Renal failure requiring dialysis.
- Acute illness, active systemic infection, or sepsis.
- Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical trial results.
- Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence.
- Current or anticipated participation in any other clinical trial of a drug, device, or biologic during the duration of the study, unless pre-approved by the Sponsor
- Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.
- Known drug or alcohol dependency.
- Life expectancy less than 12 months.
- Vulnerable subject.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SpherePVI™ Catheter
Subjects treated with the SpherePVI™ Catheter
|
Affera SpherePVI™ Multi-Ablation System
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of subjects experiencing a primary safety event
Time Frame: 6 months
|
The primary safety outcome is the incidence of the following serious device-related Primary Adverse Events (AEs) occurring within 7 days of the index ablation procedure:
|
6 months
|
Percentage of subjects with acute procedure success
Time Frame: Index ablation procedure
|
The primary efficacy outcome is acute electrical isolation of all pulmonary veins using the study device
|
Index ablation procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of subjects experiencing a device- or procedure-related serious adverse event
Time Frame: 12 months
|
The secondary safety outcome is the proportion of subjects experiencing device- or procedure-related serious adverse events (SAEs) as assessed at each follow-up visit
|
12 months
|
Product performance evaluated on a 5-point semi-quantitative scale ("strongly disagree" to "strongly agree")
Time Frame: Index ablation procedure
|
Acute product performance will be evaluated during the procedure and includes the following:
|
Index ablation procedure
|
Percentage of subjects free from documented recurrence outside of the blanking period
Time Frame: 12 Months
|
Chronic efficacy will be evaluated as freedom from documented arrhythmia recurrence outside of a 90-day blanking period.
Failure will be reported as both (i) recurrence of AF and (ii) recurrence of any atrial tachyarrhythmia (AF, atrial tachycardia, or atrial flutter).
|
12 Months
|
Percentage of pulmonary veins remaining isolated at remapping
Time Frame: 75 days
|
Chronic efficacy may also be evaluated during an optional remapping procedure and will include the following:
|
75 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP-00013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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