The purpose of the study is to provide ongoing post-market demonstration of the safety and performance of the FARAPULSEPulsed Field Ablation System in the treatment of patients with paroxysmal atrial fibrillation (PAF).
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary safety endpoint is the Composite Safety Endpoint (CSE) defined as
the proportion of Safety Subjects with one or more of the
following device- or procedure-related SAEs as adjudicated by the CEC based on
protocol definitions.
Early onset (within 7 days of an index or Rescheduled Index procedure:
• Death
• Myocardial infarction
• Persistent phrenic nerve palsy
• Stroke
• Transient ischemic attack (TIA)
• Peripheral or organ thromboembolism
• Cardiac tamponade / perforation
• Pericarditis
• Pulmonary edema
• Vascular access complications
• Heart block
• Gastric motility/pyloric spasm disorders
Late onset (any time through the completion of 12 month follow-up visit)
• Pulmonary vein stenosis
• Atrio-esophageal fistula
Secondary outcome
1. Severe Ablation Complications
2. Nonserious / Serious CSEs
3. Post-Blanking Direct Current Cardioversions
4. Post-Blanking Arrhythmia Hospitalizations
5. Any Related SAE
6. Any Related Stroke or TIA
Background summary
Atrial fibrillation is an irregular and often rapid heart rate that can
increase the risk of stroke, heart failure and other heart-related
complications. During atrial fibrillation, the heart's two upper chambers (the
atria) beat chaotically and irregularly * out of coordination with the two
lower chambers (the ventricles) of the heart.
The first line of treatment is typically drug therapy and direct current
cardioversion (DCCV). DCCV is a medical procedure to convert an abnormal heart
rate back to normal rhythm using electricity and/or drugs. As a reasonable
alternative to restoring sinus rhythm via long-term pharmacologic therapy,
catheter ablation is being performed with greater frequency. Cardiac ablation
is a procedure that is used to scar small areas in your heart that may be
involved in your heart rhythm problems. This can prevent the abnormal
electrical signals or rhythms from moving through the heart.
The FARAPULSE* Pulsed Field Ablation System places a catheter in the pulmonary
veins connected to your heart and delivers pulsed electric energy to the veins
where the misfiring in your heart first starts. This study ablation device will
be delivered through a puncture to the femoral vein in your leg. FARAPULSE is
conducting a post market clinical study to evaluate whether this ablation
procedure improves heart rhythm.
Study objective
The purpose of the study is to provide ongoing post-market demonstration of the
safety and performance of the FARAPULSE
Pulsed Field Ablation System in the treatment of patients with paroxysmal
atrial fibrillation (PAF).
Study design
Subjects will undergo percutaneous endocardial ablation for pulmonary vein
isolation using the FARAPULSE Pulsed Field Ablation System. Subjects with
typical right-sided (isthmus-dependent) atrial flutter (AFL) may undergo
ablative interruption of the cavo-tricuspid isthmus (CTI).
Class I/III antiarrhythmic drugs (AADs) will be discontinued at Day 60 ± 10,
subject to investigator discretion.
Subjects will then be followed at 7 days, 30 days, 90 days, 6 months, and 12
months for adverse events (AEs).
Subjects will be monitored with weekly scheduled plus symptom-driven event
monitoring, as well as 6 and 12-month Holter monitoring, for freedom from
recurrent arrhythmia AF, AFL or atrial tachycardia ) after the Blanking Period
(Days 0 - 90).
Several analysis populations are defined for this study, including:
- Safety subjects
- Modified intent-to-treat (mITT) subjects
- Per Protocol (PP) subjects
Study burden and risks
Subject*s participation in this study will last 13 months and consists of a
screening period, treatment period and a follow-up period.
The following is not Standard of Care:
Study Consent form to be signed.
The use of event monitor
Quality of life questionnaires (EQ-5D-3L & AFEQT) to be filled in at 2 visits
Follow-up visits phone call
TEE/ICE (is SoC in UMCG, not in Catherina hospital & OLVG)
CT (only UMCG)
The duration of use holter, 72h
Risks associated: Participation in the study carries additional assessments and
imaging above the standard of care.
All other study-specific assessments are clinic and physical assessments that
would be within the range of standard follow-up of patients with a this medical
history.
An additional risk of participating in a clinical study is the risk of a lapse
of confidentiality or exposure of personal identifying information.
Risk-benefit analysis; The risk involved in the clinical study is minimized due
to the fact the device being used is CE-marked and the study design falls
within the intended use population. Subjects can still receive the same device
treatment outside of the study. The risk of participating in the study is only
minimally increased as compared to receiving the device outside the study, as
there is a higher degree of imaging and clinical assessment than would be
present otherwise. Additionally, there are the risks involved in data
collection. These risks, though, have been mitigated by the benefit of
additional clinical follow-up and closer care, as well as procedures which have
been put in place to protect subjects* personal information.
3715 Haven Ave. Suite 110
Menlopark CA 94025
US
3715 Haven Ave. Suite 110
Menlopark CA 94025
US
Listed location countries
Age
Inclusion criteria
Study subjects are required to meet all the following inclusion criteria to
participate in this study:
1. Patients with PAF that meets all the following criteria:
a. Paroxysmal: AF that terminates spontaneously or with intervention within 7
days of onset.
b. Frequency:
i. Physician documentation of recurrent PAF (two or more episodes) within 6
months, AND
ii. At least one (1) documented episode by an approved recording device within
12 months of enrollment.
c. Drug Failed atrial fibrillation drug (AAD) treatment, meaning therapeutic
failure of at least one AAD (class I - IV) for efficacy and / or intolerance.
2.Patients who are >= 18 and <= 80 years of age on the day of enrollment.
3. Patient participation requirements:
a. Is willing and capable of providing Informed Consent to undergo study
procedures.
b. Is willing to participate in all examinations and follow-up visits and tests
associated with this clinical study.
Exclusion criteria
Subjects will be excluded from participating in this study if they meet any one
of the following exclusion criteria:
1. Atrial fibrillation that is any of the following:
a. Persistent (both early and longstanding) by diagnosis or continuous duration
> 7 days
b. Secondary to electrolyte imbalance, thyroid disease, alcohol or other
reversible / non-cardiac causes
c. Requires four (4) or more direct-current cardioversions in the preceding 12
months
2. Any of the following atrial conditions:
a. Left atrial anteroposterior diameter >= 5.5 cm
b. Any prior atrial endocardial or epicardial ablation procedure, other than
right sided cavotricuspid isthmus ablation or for right sided SVT
c. Any prior atrial surgery
d. Interatrial septal patch or interatrial shunt
e. Atrial myxoma
f. Current LA thrombus
g. LA appendage closure, device or occlusion
h. Any PV abnormality, stenosis or stenting (common and middle PVs are
admissible)
3. At any time, one or more of the following cardiovascular procedures,
implants or conditions:
a. Sustained ventricular tachycardia or any ventricular fibrillation
b. Hemodynamically significant valvular disease
c. Clinically significant hypertrophic cardiomyopathy
d. Any prosthetic heart valve, ring or repair including balloon aortic
valvuloplasty
e. Contraindication to femoral venous access
4. Any of the following procedures, implants or conditions:
a. At baseline:
i. Congestive heart failure with New York Heart Association (NYHA) Class III or
IV
ii. Left ventricular ejection fraction (LVEF) < 35%
iii. Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 mmHg on two BP
measurements at baseline assessment)
iv. Implantable loop recorder or insertable cardiac monitor
b. Within the 3 months preceding the Consent Date:
i. Myocardial infarction
ii. Unstable angina
iii. Percutaneous coronary intervention
iv. Implantation of a pacemaker, cardioverter defibrillator or cardiac
resynchronization therapy device
v. Heart failure hospitalization
vi. Treatment with amiodarone
vii. Pericarditis or symptomatic pericardial effusion
viii. Gastrointestinal bleeding
c. Within the 6 months preceding the Consent Date:
i. Heart surgery
ii. Stroke, TIA or intracranial bleeding
iii. Any thromboembolic event
iv. Carotid stenting or endarterectomy
5. Diagnosed disorder of blood clotting or bleeding diathesis
6. Contraindication to, or unwillingness to use, systemic anticoagulation
7. Patient who is not on anticoagulation therapy for at least 3 weeks prior to
the ablation procedure
8. Women of childbearing potential who are pregnant, lactating, not using birth
control or planning to become pregnant during the anticipated study period
9. Medical conditions that would prevent participation in the study, interfere
with assessment or therapy, significantly raise the risk of study
participation, or confound data or its interpretation, including but not
limited to:
a. Body mass index (BMI) > 45.0
b. Solid organ or hematologic transplant, or currently being evaluated for an
organ transplant
c. Severe lung disease, pulmonary hypertension, or any lung disease associated
with chronic abnormal blood gases or requiring supplemental oxygen
d. Renal insufficiency with an estimated glomerular filtration rate (eGFR) < 30
mL/min/1.73 m
or any history of renal dialysis or renal transplant
e. Active malignancy or history of treated malignancy within 24 months of
enrollment (other than cutaneous basal cell or squamous cell carcinoma)
f. Active systemic infection
g. COVID-19 disease
I. Current confirmed, active COVID-19 disease
II. Current positive test for SARS-CoV-2
III. Confirmed COVID-19 disease not clinically resolved at least 3 months prior
to the Consent Date
h. Other uncontrolled medical conditions that may modify device effect or
increase risk, including uncontrolled diabetes mellitus, untreated sleep apnea
or active alcohol abuse
i. Predicted life expectancy less than one (1) year
10. Clinically significant psychological condition that in the investigator*s
opinion would prohibit the subject's ability to meet the protocol requirements.
11. Current or anticipated enrollment in any other clinical study.
(data collection for registries or retrospective studies is permitted)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05072964 |
| CCMO | NL80016.042.21 |