The primary objective of the TactiFlex PAF IDE clinical trial is to demonstrate that ablation with the TactiFlex* Ablation Catheter, Sensor-Enabled* (TactiFlex SE), in conjunction with a compatible RF generator and three-dimensional mapping system,…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary safety endpoint is the rate of device and/or procedure-related
serious adverse events with onset within 7-days of any ablation procedure that
uses the TactiFlex SE catheter (initial or repeat procedure performed 31-80
days of initial procedure) that are defined below:
• Atrio-esophageal fistula1
• Cardiac tamponade/perforation1
• Death
• Heart block
• Myocardial infarction
• Pericarditis
• Phrenic nerve injury resulting in diaphragmatic paralysis
• Pulmonary edema
• Pulmonary vein stenosis1
• Stroke/cerebrovascular accident
• Thromboembolism
• Transient ischemic attack
• Vagal nerve injury/gastroparesis
• Vascular access complications (including major bleeding events2)
Secondary outcome
not applicable
Background summary
It has been estimated that 33.5 million people have atrial fibrillation (AF)
worldwide [1]. AF has a prevalence of approximately 3% in adults aged 20 years
or older [2, 3]. Additionally, one in four middle-aged adults in the US and
EMEA will develop AF in their lifetime [4, 5].
AF remains a major cause of stroke, heart failure, sudden death, and
cardiovascular morbidity. In a meta-analysis of contemporary, well-controlled,
randomized clinical trials in AF, the average annual stroke rate is 1.5% with
an annualized death rate of 3% in anticoagulated AF patients [6]. A minority of
these deaths are related to stroke, while sudden cardiac death and death from
progressive heart failure are more frequent, emphasizing the need for
interventions beyond anticoagulation [7, 8]. AF is also associated with high
rates of hospitalization for AF management, treatment-associated complications,
heart failure and myocardial infarction [9, 10]. Patients with AF have
significantly reduced quality of life vs. healthy controls, experiencing a
variety of symptoms including lethargy, palpitations, dyspnea, chest pain,
sleeping difficulties, and mental distress [10-14] .
Treatment for AF includes thromboembolic risk management, heart rate control,
and heart rhythm control, which includes cardioversion and catheter ablation.
The 2014 AHA/ACC/HRS AF Guidelines, 2016 ESC AF Guidelines, and 2017
HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus on AF Ablation all provide a Class
I recommendation (Level of Evidence: A) for catheter ablation to maintain sinus
rhythm for patients with symptomatic, drug refractory, paroxysmal AF [15-17].
Contact force-sensing ablation catheter systems are a technology that is
growing in adoption for AF ablation. These contact force-sensing catheter
systems provide catheter operators additional feedback by allowing the operator
to know how much force is being applied by the catheter tip on the cardiac
tissue.
The TactiCath family of contact force-sensing catheters from Abbott has been
studied extensively in human clinical trials [18-22]. The latest TactiCathTM
contact force sensing catheter from Abbott is the TactiCath SE ablation
catheter, which incorporates a magnetic sensor for tracking with the EnSite
Precision Mapping System and utilizes a new handle and shaft to improve
catheter handling. The TactiCath SE catheter is being investigated by the
TactiSense clinical trial [23].
The flexible-tip (*flex-tip*) family of ablation catheters (TherapyTM
CoolFlexTM, FlexAbilityTM, FlexAbilityTM SE) from Abbott offers a tip design
that is significantly different from the rigid-tip TactiCath family. While
both catheter families provide irrigating saline through 4-6 discrete holes at
the distal tip, only the flex-tip family provides irrigating saline through an
interlocking pattern of kerfs laser-cut into the side of the electrode that is
both flexible and porous. The purpose of having the saline irrigated over a
more widely distributed area is to produce a more uniform temperature profile,
potentially increasing the efficiency of energy transfer [24] and reducing the
risk of steam-pops [25]. The Therapy CoolFlex ablation catheter has been
studied in humans for the treatment of typical atrial flutter [26] and the
entire flex-tip family is indicated for the treatment of typical atrial flutter
in the US. Outside of the US, the flex-tip family of catheters is indicated
for treating cardiac arrhythmias and is used to treat AF. The safety and
effectiveness of flex-tip catheters has been studied for the treatment of
paroxysmal AF in a real-world setting through the ABLATOR patient registry [27].
The TactiFlex* Ablation Catheter, Sensor-Enabled* (TactiFlex SE) is the next
generation design from Abbott, and it has several elements that are similar or
identical to the FlexAbility SE and/or TactiCath SE ablation catheters. The
contact force sensor, handle (uni- or bi-directional) and shaft are like
TactiCath SE. Meanwhile, the porous flex-tip ablation electrode and therapy RF
circuit are like FlexAbility SE. Unlike TactiCath SE and FlexAbility SE,
TactiFlex SE has a second magnetic sensor that enables the force direction
arrow and deflection/direction features in the EnSite Precision cardiac mapping
system (v2.5).
Study objective
The primary objective of the TactiFlex PAF IDE clinical trial is to demonstrate
that ablation with the TactiFlex* Ablation Catheter, Sensor-Enabled* (TactiFlex
SE), in conjunction with a compatible RF generator and three-dimensional
mapping system, is safe and effective for the treatment of drug refractory,
symptomatic paroxysmal atrial fibrillation (PAF) when following standard
electrophysiology mapping and radiofrequency (RF) ablation procedures.
Study design
Prospective, non-randomized multi-center clinical investigation. Design
includes a main study and a separate substudy. Subjects in the main study are
to be treated using the full range of ablation power settings in the IFU.
Subjects in the substudy are to be treated in the upper end of the recommended
ablation power settings (40-50 Watts).
Remark: Erasmus MC will not participate to the sub-study.
Intervention
Catheter ablation
Study burden and risks
We expect that the risks associated with the investigation are the same as the
normal risks associated with an ablation procedure.
Additional risks are described in the protocol Page 63 -15.0 Risk Analysis.
These are also included / described in the Patient Information Letter.
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Listed location countries
Age
Inclusion criteria
1. Plans to undergo a catheter ablation procedure due to symptomatic PAF that
is refractory or intolerant to at least one Class I or III antiarrhythmic drug.
2. Physician*s note indicating recurrent self-terminating AF
3. One electrocardiographically documented AF episode within 6-months prior to
the initial ablation procedure. Documented evidence of the AF episode must
either be continuous AF on a 12-lead ECG or include at least 30 seconds of AF
from another ECG device.
4. At least 18 years of age
5. Able and willing to comply with all trial requirements
6. 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. Persistent or long-standing persistent atrial fibrillation
2. Active systemic infection
3. Known presence of cardiac thrombus
4. Hypertrophic cardiomyopathy
5. Arrhythmia due to reversible causes including thyroid disorders, acute
alcohol intoxication, and other major surgical procedures in the 90-day period
preceding procedure
6. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary
intervention (PCI), or valve or coronary bypass grafting surgery within 90 days
of procedure
7. Left atrial diameter > 5.0 cm measured within 180 days of procedure
(echocardiography or CT)
8. Left ventricular ejection fraction < 35% measured within 180 days of
procedure (echocardiography or CT)
9. New York Heart Association (NYHA) class III or IV
10. Previous left atrial surgical or catheter ablation procedure
11. Left atrial surgical procedure or incision with resulting scar (including
LAA closure device)
12. Previous tricuspid or mitral valve replacement or repair
13. Heart disease in which corrective surgery is anticipated within 180 days
after the procedure
14. Bleeding diathesis or suspected pro-coagulant state
15. Contraindication to long term anti-thromboembolic therapy
16. Presence of any condition that precludes appropriate vascular access
17. Renal failure requiring dialysis
18. Known sensitivity to contrast media (if needed during the procedure) that
cannot be controlled with pre-medication
19. 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
20. Women who are pregnant or breastfeeding
21. Presence of other anatomic or comorbid condition that, in the
investigator*s opinion, could limit the patient*s ability to participate in the
clinical trial or to comply with follow up requirements, or impact the
scientific soundness of the clinical trial results
22. 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
23. Patient is unlikely to survive the protocol follow up period of 12-months
after the procedure
24. Body mass index > 40 kg/m2
25. Presence of other medical, 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.
26. Individuals without legal authority
27. Individuals unable to read or write
28. Patients who have had a ventriculotomy or atriotomy within the preceding 4
weeks of procedure,
29. Patients with prosthetic valves,
30. Patients with a myxoma,
31. Patients with an interatrial baffle or patch as the transseptal puncture
could persist and produce an iatrogenic atrial shunt
32. Patient unable to receive heparin or an acceptable alternative to achieve
adequate anticoagulation.
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 | NL72742.078.20 |