The objective of this clinical trial is to demonstrate that ablation with the TactiFlex* SE Ablation Catheter, Sensor Enabled* (TactiFlex PFA), in conjunction with a compatible PFA and/or RF generator, is safe and effective for the treatment of…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary safety endpoint is the proportion of subjects experiencing a device
and/or procedure-related serious adverse event (SAE) with onset within 7 days
of any ablation procedure (index or repeat procedure performed 0-90 days post
initial procedure) that uses the TactiFlex PFA System defined below:
• Esophageal perforating complications1
• Cardiac tamponade/perforation2
• Death
• Heart block
• Myocardial infarction
• Pericarditis3
• Phrenic nerve injury resulting in diaphragmatic paralysis
• Pulmonary edema
• Pulmonary vein stenosis1
• Stroke/cerebrovascular accident
• Thromboembolism
• Transient ischemic attack
• Vagal nerve injury/gastroparesis
• Major vascular access complications4 / major bleeding event5
• Device and/or procedure related cardiovascular and/or pulmonary adverse event
that prolongs hospitalization for more than 48 hours (excluding hospitalization
solely for arrhythmia recurrence or non-urgent cardioversion)
The primary effectiveness endpoint for this clinical trial is freedom from
documented (symptomatic or asymptomatic) AF/AFL/AT episodes of >30 seconds
duration that are documented by protocol-specified 12-lead ECG, TTM or Holter
monitor (HM) devices after the index ablation procedure through 12 months of
follow-up (after a 90-day blanking period following the index ablation
procedure).
Secondary outcome
The Symptomatic Secondary Effectiveness Endpoint has the same definition as the
Primary Effectiveness endpoint, except that a documented recurrence without
documentation of symptoms after the 90-day blanking period will not count as a
therapy failure in this analysis.
The AAD-Free Secondary Effectiveness Endpoint has the same definition as the
Primary Effectiveness endpoint, except that any use of Class I or III AADs
after the 90-day blanking period will count as a therapy failure in this
analysis.
Descriptive endpoints are reported using only summary statistics and no
hypothesis testing will be performed.
• Acute procedural effectiveness, defined as confirmation of entrance block in
all pulmonary veins after a minimum waiting period of 20-minutes.
• Proportion of subjects with successful first-pass isolation of all targeted
veins, and proportion of all targeted pulmonary veins with successful
first-pass pulmonary vein (PV) isolation. First-pass isolation is defined as
confirmation of entrance block in each pulmonary vein after completion of the
initial lesion set and 20-minute wait period, with no reconnection occurring
during the 20-minute wait period.
• 12-month single procedure effectiveness, defined the same as the Primary
Effectiveness Endpoint, except that any repeat ablation procedure (excluding
CTI-dependent AFL) required by the subject at any time will be deemed a failure.
• Proportion of subjects requiring one or more repeat AF, non-CTI dependent
AFL, or AT ablations through 12-months following the initial AF ablation
procedure. Of those subjects with repeat ablations including access to the left
atrium, the proportion of treated pulmonary veins ablated with reconnections,
the locations and energy modality used in the area of pulmonary vein
reconnections (of treated veins) upon electro-anatomical remapping.
• Changes in EQ-5D-5L and AFEQT (AF Effect on Quality-Of-Life Questionnaire)
scores from baseline to follow up at 3, 6, and 12-months after the initial
procedure.
• Procedure data, including but not limited to ablation data, mapping data,
usage of PFA and RF energy, contact force, procedure time, fluoroscopy time,
total ablation time, left atrial (LA) dwell time, time to perform pulmonary
vein isolation (PVI), and ablation performed in addition to PVI.
• Arrhythmia monitoring (12-lead ECG, HM, and TTM) compliance.
• All-cause death further divided into sudden cardiac death (SCD).
• Number and location of PFA applications during any study-related ablation
procedure(s) in subjects with peri-procedural coronary artery spasm, acute
myocardial infarction, or progressive angina due to long-term coronary damage
(such as chronic neointimal hyperplasia or atherosclerosis).
• Change in PV diameter from baseline to 3 months post-procedure.
• Incidence, number, size (diameter and volume) and anatomic location of
cerebral lesions detected on post-procedure brain MRI compared to pre-procedure
brain MRI.
• Summary of sub-study hemolysis and myolysis lab values at baseline and
post-procedure
• Freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of
>30 seconds duration that are documented by protocol-specified 12-lead ECG, TTM
or Holter monitor (HM) after the index ablation procedure through 6 months of
follow-up (after a 90-day blanking period following the index ablation
procedure).
Background summary
It has been estimated that 33.5 million people have atrial fibrillation (AF)
worldwide.
AF is associated with mortality and comorbidities such as stroke, heart
failure, and sudden cardiac death. Atrial fibrillation is also associated with
high rates of hospitalization. Additionally, patients with AF have
significantly poorer quality of life than healthy controls, experiencing a
variety of symptoms including lethargy, palpitations, dyspnea, chest pain,
sleeping difficulties, and mental distress.
Treatment for AF includes thromboembolic risk management, heart rate control,
and heart rhythm control, which includes cardioversion and catheter ablation.
The 2023 ACC/AHA/ACCP/HRS Guidelines for the Diagnosis and Management of Atrial
Fibrillation provide Class I recommendations (Level of Evidence: A) for
catheter ablation to improve symptoms in patients with drug-refractory, PAF and
as a first-line therapy to improve symptoms and reduce progression to
persistent AF in selected patients with symptomatic paroxysmal AF in whom
rhythm control is desired.4 The effect of AF treatment is supported by reports
of persistently improved quality of life 10 years after paroxysmal AF catheter
ablation in patients with a low AF progression rate.4
The current conventional approach to perform catheter ablation is via thermal
energy, such as cryoablation or radiofrequency (RF) energy, to achieve
pulmonary vein isolation (PVI). However, there are some limitations to the
current standard of care ablation technologies. The reliance of these
technologies on conductive heating and cooling results in a thermal response
that is not selective to myocardial tissue. Irreversible electroporation (IRE)
is a mechanism of inducing cell death via the application of pulsed electric
fields (PEF). Pulsed field ablation (PFA) utilizes IRE to selectively
destabilize cellular membranes to initiate cell death, resulting in a
non-thermal ablation lesion. Interestingly, myocardial tissue has a lower
voltage threshold susceptible to PFA when compared to surrounding tissues such
as the esophagus, blood vessels, and nerve fibers, therefore reducing risk of
damage to these non-cardiac tissues and potentially lowering rates of
associated adverse events.
The majority of PFA catheters in clinical trials to date have been *single-
shot* devices for PVI alone. These catheters are limited in their ability to
ablate beyond the pulmonary veins and have been limited to delivering PFA.
Focal catheters are used for the majority of atrial fibrillation ablation
procedures and provide flexibility of lesions sets beyond PVI. Additionally,
they may allow for the flexibility to deliver either PFA or RF energy through
the same catheter. Studies of focal PFA catheters to date have demonstrated
safety, procedural efficiency, and lesion durability.
The TactiFlex SE catheter previously demonstrated safe and effective delivery
of RF energy for the treatment of symptomatic, recurrent, drug-refractory PAF
and concomitant atrial flutter. With the growing burden of AF on the healthcare
system and continued need for increased safety and effectiveness in treatments,
the TactiFlex* PFA System has been developed for enhanced flexibility to
deliver either RF or PF energy for the safe and effective treatment of
symptomatic, recurrent drug refractory PAF.
Study objective
The objective of this clinical trial is to demonstrate that ablation with the
TactiFlex* SE Ablation Catheter, Sensor Enabled* (TactiFlex PFA), in
conjunction with a compatible PFA and/or RF generator, is safe and effective
for the treatment of symptomatic, recurrent, drug refractory PAF.
Study design
Pre-market, prospective, single-arm, non-randomized, multicenter clinical study
Intervention
Pulsed Field Ablation met het TactiFlex PFA system
Study burden and risks
Possible risks associated with participating in this clinical study are not
anticipated to be any different from risks associated with undergoing
procedures with commercially available ablation catheters approved for the
treatment of symptomatic, recurrent, drug-refractory PAF.
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Listed location countries
Age
Inclusion criteria
1. Documented symptomatic paroxysmal AF (PAF). Documentation requirements are
as follows:
a. Physician*s note indicating recurrent self-terminating AF with >= 2 episodes
of PAF within the 6 months prior to enrollment AND
b. One electrocardiographically documented PAF episode within 12 months prior
to enrollment.
NOTE: Documented evidence of the AF episode must either be continuous AF on a
12-lead ECG or include at least 30 seconds of continuous AF from another ECG
device.
2. Plans to undergo a catheter ablation procedure due to symptomatic PAF and is
refractory, intolerant, or contraindicated to at least one Class I-IV AAD
medication
3. At least 18 years of age
4. Able and willing to comply with all trial requirements including
pre-procedure, post-procedure, and follow-up testing and requirements
5. Informed of the nature of the trial, agreed to its provisions, and has
provided written informed consent as approved by the Institutional Review
Board/Ethics Committee (IRB/EC) of the respective clinical trial site.
Exclusion criteria
1. Previously diagnosed persistent or long-standing persistent atrial
fibrillation (Continuous AF greater than 1 year in duration)
2. Arrhythmia due to reversible causes including thyroid disorders, acute
alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and
other major surgical procedures in the preceding 90 days
3. Known presence of cardiac thrombus
4. Left atrial diameter (LAD) > 5.0 cm (anteroposterior diameter) within 180
days prior to the index procedure
5. Left ventricular ejection fraction (LVEF) < 35% as assessed with
echocardiography or computerized tomography (CT) within 180 days prior to the
index procedure
6. New York Heart Association (NYHA) class III or IV heart failure
7. Body mass index > 40 kg/m2
8. Pregnant or nursing
9. Patients who have had a ventriculotomy or atriotomy within the preceding 28
days of procedure
10. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary
intervention (PCI), or valve or coronary bypass grafting surgery within
preceding 90 days
11. Stroke or TIA (transient ischemic attack) within the last 90 days
12. Heart disease in which corrective surgery is anticipated within 180 days
after procedure
13. History of blood clotting or bleeding abnormalities including
thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected
anti-coagulant state
14. Contraindication to long-term anti-thromboembolic therapy
15. Patient unable to receive heparin or an acceptable alternative to achieve
adequate anticoagulation
16. Known sensitivity to contrast media (if needed during the procedure) that
cannot be controlled with pre-medication
17. Previous left atrial surgical or left atrial catheter ablation procedure
(including left atrial appendage (LAA) closure device)
18. Plans to have an LAA closure device implanted during the follow-up period
19. Presence of any condition that precludes appropriate vascular access
20. Severe mitral regurgitation (regurgitant volume >= 60 mL/beat, regurgitant
fraction >= 50%, and/or effective regurgitant orifice area >= 0.40cm2)
21. Previous tricuspid or mitral valve replacement or repair
22. Patients with prosthetic valves
23. Patients with a myxoma
24. Patients with an interatrial baffle or patch as the transseptal puncture
could persist and produce an iatrogenic atrial shunt
25. Stent, constriction, or stenosis in a pulmonary vein
26. Rheumatic heart disease
27. Hypertrophic cardiomyopathy
28. Active systemic infection
29. Renal failure requiring dialysis
30. Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive
or chronic obstructive pulmonary disease) or any other disease or malfunction
of the lungs or respiratory system that produces severe chronic symptoms
31. Presence of an implantable therapeutic cardiac device including permanent
pacemaker, biventricular pacemaker, or any type of implantable cardiac
defibrillator (with or without biventricular pacing function) or planned
implant of such a device for any time during the follow-up period. Presence of
an implantable loop recorder is acceptable as long as it is removed prior to
insertion of the investigational device.
32. Patient is currently participating in another clinical trial or has
participated in a clinical trial within 30 days prior to screening that may
interfere with this clinical trial without pre-approval from this study Sponsor
33. Unlikely to survive the protocol follow up period of 12 months
34. Presence of other medical, anatomic, comorbid, social, or psychological
conditions that, in the investigator*s opinion, could limit the subject*s
ability to participate in the clinical investigation or to comply with
follow-up requirements, or impact the scientific soundness of the clinical
investigation results.
35. Individuals without legal authority
36. Individuals unable to read or write
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 |
|---|---|
| CCMO | NL87527.000.24 |