Brief Summary
The ADVENT Post Approval Study (PAS) is a prospective, global, multicenter, observational study.
Brief Title
ADVENT Post Approval Study
Detailed Description
The objective of ADVENT PAS is to evaluate the long-term safety and effectiveness profile of the FARAPULSE Pulsed Field Ablation System when used to perform pulmonary vein isolation (PVI) in the de-novo ablation treatment of patients with paroxysmal atrial fibrillation (PAF).
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
1-612-403-7653
Central Contact Email
sharon.mensah@bsci.com
Central Contact Role
Contact
Central Contact Phone
651-582-5077
Central Contact Email
Giovanni.Raciti@bsci.com
Completion Date
Completion Date Type
Estimated
Conditions
Paroxysmal Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
* Subjects with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF) who are indicated for a treatment with the FARAPULSE Pulsed Field Ablation (PFA) System\*; (Subjects refractory, or intolerant or contraindicated to at least one class I or III antiarrhythmic medication or contraindicated to any class I or III medications.)
* Subjects who are willing and capable of providing informed consent;
* Subjects who are willing and capable of participating in all testing and follow-up associated with this clinical study at an approved clinical investigational site;
* Subjects who are of legal age to give informed consent specific to the national law.
* For the LUX-Dx Sub-Study: Subjects with an existing LUX-Dx Insertable Cardiac Monitor (ICM), inserted ≥ 180 days prior to enrollment, or having a LUX-Dx ICM inserted per the investigator's standard of care, up to 7 days after the ablation procedure. Subjects with or having a LUX-Dx ICM inserted per standard of care, up to 7 days after the ablation procedure.
Exclusion Criteria:
* Subjects with any known contraindication to an AF ablation or anticoagulation, including those listed in the Instructions For Use (IFU);
* Subjects with any prior left atrium (LA) ablation;
* Subjects who may need an ablation in the left atrium besides PVI, such as for left-sided atrioventricular reentrant tachycardia (AVRT), left-sided atrial tachycardia (AT) or atypical left-sided atrial flutter (AFL);
* Women of childbearing potential who are or plan to become pregnant during the time of the study (assessment per investigator's discretion);
* Life expectancy of \< 1 year, per investigator's medical judgement.
* Subjects with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF) who are indicated for a treatment with the FARAPULSE Pulsed Field Ablation (PFA) System\*; (Subjects refractory, or intolerant or contraindicated to at least one class I or III antiarrhythmic medication or contraindicated to any class I or III medications.)
* Subjects who are willing and capable of providing informed consent;
* Subjects who are willing and capable of participating in all testing and follow-up associated with this clinical study at an approved clinical investigational site;
* Subjects who are of legal age to give informed consent specific to the national law.
* For the LUX-Dx Sub-Study: Subjects with an existing LUX-Dx Insertable Cardiac Monitor (ICM), inserted ≥ 180 days prior to enrollment, or having a LUX-Dx ICM inserted per the investigator's standard of care, up to 7 days after the ablation procedure. Subjects with or having a LUX-Dx ICM inserted per standard of care, up to 7 days after the ablation procedure.
Exclusion Criteria:
* Subjects with any known contraindication to an AF ablation or anticoagulation, including those listed in the Instructions For Use (IFU);
* Subjects with any prior left atrium (LA) ablation;
* Subjects who may need an ablation in the left atrium besides PVI, such as for left-sided atrioventricular reentrant tachycardia (AVRT), left-sided atrial tachycardia (AT) or atypical left-sided atrial flutter (AFL);
* Women of childbearing potential who are or plan to become pregnant during the time of the study (assessment per investigator's discretion);
* Life expectancy of \< 1 year, per investigator's medical judgement.
Inclusion Criteria
Inclusion Criteria:
* Subjects with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF) who are indicated for a treatment with the FARAPULSE Pulsed Field Ablation (PFA) System\*; (Subjects refractory, or intolerant or contraindicated to at least one class I or III antiarrhythmic medication or contraindicated to any class I or III medications.)
* Subjects who are willing and capable of providing informed consent;
* Subjects who are willing and capable of participating in all testing and follow-up associated with this clinical study at an approved clinical investigational site;
* Subjects who are of legal age to give informed consent specific to the national law.
* For the LUX-Dx Sub-Study: Subjects with an existing LUX-Dx Insertable Cardiac Monitor (ICM), inserted ≥ 180 days prior to enrollment, or having a LUX-Dx ICM inserted per the investigator's standard of care, up to 7 days after the ablation procedure. Subjects with or having a LUX-Dx ICM inserted per standard of care, up to 7 days after the ablation procedure.
* Subjects with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF) who are indicated for a treatment with the FARAPULSE Pulsed Field Ablation (PFA) System\*; (Subjects refractory, or intolerant or contraindicated to at least one class I or III antiarrhythmic medication or contraindicated to any class I or III medications.)
* Subjects who are willing and capable of providing informed consent;
* Subjects who are willing and capable of participating in all testing and follow-up associated with this clinical study at an approved clinical investigational site;
* Subjects who are of legal age to give informed consent specific to the national law.
* For the LUX-Dx Sub-Study: Subjects with an existing LUX-Dx Insertable Cardiac Monitor (ICM), inserted ≥ 180 days prior to enrollment, or having a LUX-Dx ICM inserted per the investigator's standard of care, up to 7 days after the ablation procedure. Subjects with or having a LUX-Dx ICM inserted per standard of care, up to 7 days after the ablation procedure.
Gender
All
Gender Based
false
Keywords
Pulsed Field Ablation
PFA
Pulmonary Vein Isolation
PVI
Ablation
Atrial Fibrillation
AF
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06431815
Org Class
Industry
Org Full Name
Boston Scientific Corporation
Org Study Id
PF304
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Prospective, Multi-site Safety and Effectiveness Post-Approval Study of FARAPULSE Pulsed Field Ablation in Paroxysmal Atrial Fibrillation
Primary Outcomes
Outcome Description
* Early Onset: Acute primary safety endpoint events, events occurring up to 7 days post-Index Procedure or hospital discharge, whichever is later including serious procedure-related and device-related adverse events.
* Death
* Myocardial infarction (MI)
* Persistent phrenic nerve palsy
* Stroke/Cerebrovascular accident (CVA)
* Transient ischemic attack (TIA)
* Peripheral or organ thromboembolism
* Cardiac tamponade / perforation
* Pericarditis
* Pulmonary edema
* Serious vascular access complications
* Heart block
* Gastric motility / pyloric spasm disorders
* Severe hemolysis with subsequent renal injury or significant anemia
* Late Onset: Either of the following with an onset date any time through 12-month post-Index Procedure:
* Atrial esophageal fistula
* Pulmonary vein stenosis (≥ 70% reduction of diameter)
* Death
* Myocardial infarction (MI)
* Persistent phrenic nerve palsy
* Stroke/Cerebrovascular accident (CVA)
* Transient ischemic attack (TIA)
* Peripheral or organ thromboembolism
* Cardiac tamponade / perforation
* Pericarditis
* Pulmonary edema
* Serious vascular access complications
* Heart block
* Gastric motility / pyloric spasm disorders
* Severe hemolysis with subsequent renal injury or significant anemia
* Late Onset: Either of the following with an onset date any time through 12-month post-Index Procedure:
* Atrial esophageal fistula
* Pulmonary vein stenosis (≥ 70% reduction of diameter)
Outcome Measure
Composite incidence of patients with procedure-related and device-related serious adverse events at 7-Days and 12-months post-Index Procedure.
Outcome Time Frame
12 Months
Outcome Description
\- Acute Procedural Success: Acute procedural success is defined as isolation of all clinically relevant pulmonary veins or anatomical equivalents using the FARAPULSE Pulsed Field Ablation System only
AND
\- Chronic Success, defined as freedom from the following:
After the Blanking Period up to the 12-Month Follow-up visit:
* Occurrence of any Detectable AF, AFL, AT
* ≥ 30 seconds in duration from any approved clinical recording devices considered standard of care at the study center (excluding implantable loop recorders) or
* ≥ 10-second of continuous AF, AFL or AT documented on any 12-lead ECG
* Following interventions:
* Any cardioversion for AF, AFL or AT
* Prescribed a higher dose of any failed Class I or III Antiarrhythmic Drug (AAD) documented at baseline or any new Class I or III AAD
* Re-ablation for AF, AFL or AT (other than for cavotricuspid isthmus (CTI)-dependent flutter only)
AND
\- Chronic Success, defined as freedom from the following:
After the Blanking Period up to the 12-Month Follow-up visit:
* Occurrence of any Detectable AF, AFL, AT
* ≥ 30 seconds in duration from any approved clinical recording devices considered standard of care at the study center (excluding implantable loop recorders) or
* ≥ 10-second of continuous AF, AFL or AT documented on any 12-lead ECG
* Following interventions:
* Any cardioversion for AF, AFL or AT
* Prescribed a higher dose of any failed Class I or III Antiarrhythmic Drug (AAD) documented at baseline or any new Class I or III AAD
* Re-ablation for AF, AFL or AT (other than for cavotricuspid isthmus (CTI)-dependent flutter only)
Outcome Measure
Treatment success, defined as the incidence of subjects with successful isolation of clinically relevant pulmonary veins AND patients without recurrence or interventions for AF, AFL, AT after the blanking period through 12 months.
Outcome Time Frame
12 Months
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Subjects with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF) who are indicated for a de-novo pulmonary vein isolation ablation with the FARAPULSE Pulsed Field Ablation (PFA) System.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Luigi Dibiase
Investigator Email
ldibiase@montefiore.org
Investigator Phone
347-271-1637
Investigator Department
Medicine
Investigator Division
Cardiology
Investigator Sponsor Organization
External
Study Department
Medicine
Study Division
Cardiology
Categories Mesh Debug
Heart/Cardiovascular --- ATRIAL FIBRILLATION
Heart/Cardiovascular --- ARRHYTHMIAS, CARDIAC
Brain, Spinal Cord & Nervous System --- HEART DISEASES
Heart/Cardiovascular --- HEART DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
MeSH Terms
ATRIAL FIBRILLATION
ARRHYTHMIAS, CARDIAC
HEART DISEASES
CARDIOVASCULAR DISEASES
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS