To demonstrate the safety and effectiveness of the IntellaNav StablePoint Catheter and Force Sensing System with DIRECTSENSE for treatment of drug refractory, recurrent, symptomatic Paroxysmal Atrial Fibrillation (PAF).
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Safety Endpoint at 30 Days
The primary safety endpoint at 30 days is defined as the safety event-free rate
at 30 days post-procedure.
Primary safety events at 30 days will consist of a composite of the following
serious procedure-related and/or device-related adverse events. Events will be
counted through 7 days post index procedure or hospital discharge, whichever is
later, unless denoted as events counting through 30 days post index procedure.
* Death
* Myocardial infarction (MI)
* Vagal Nerve Injury/Gastroparesis
* Transient ischemic attack (TIA)
* Stroke/Cerebrovascular accident (CVA)
* Thromboembolism
* Pericarditis
* Cardiac tamponade/perforation
* Pneumothorax
* Major vascular access complications
* Pulmonary edema/heart failure
* AV block
* Atrial esophageal fistula
* Severe pulmonary vein stenosis (*70% reduction in the diameter of the PV or
PV branch from baseline)
Primary Safety Endpoint at 12 Months
The primary safety endpoint at 12 months is defined as the safety event-free
rate at 12 months post-procedure.
Primary safety events at 12 months will consist of a composite of the following
serious procedure-related and/or device-related adverse events.
The following events will be counted through 7 days post index procedure or
hospital discharge, whichever is later:
* Death
* Myocardial infarction (MI)
* Vagal Nerve Injury/Gastroparesis
* Transient ischemic attack (TIA)
* Stroke/Cerebrovascular accident (CVA)
* Thromboembolism
* Pericarditis
* Pneumothorax
* Major vascular access complications
* Pulmonary edema/heart failure
* AV block
The following events will be counted through 30 days post index procedure:
* Cardiac tamponade/perforation
And the following events will be counted through 12 months post index procedure:
* Atrial esophageal fistula
* Severe pulmonary vein stenosis (*70% reduction in the diameter of the PV or
PV branch from baseline)
* Persistent phrenic nerve palsy
Primary Effectiveness Endpoint * Acute Procedural Success
The primary effectiveness endpoint of acute procedural success is defined as
the achievement of electrical isolation of all PVs using the IntellaNav
StablePoint Catheter only. Electrical isolation of a PV is demonstrated by
entrance block after a 20-minute waiting period. If exit block testing is
performed, the PV will only be considered isolated if both entrance and exit
block testing was successful.
Primary Effectiveness Endpoint at 6 Months
This primary effectiveness endpoint at 6 months is defined as the primary
effectiveness event-free rate at 6 months post-procedure.
Primary effectiveness events determining a failure are defined as:
* Acute procedural failure
* Use of amiodarone post index procedure
* Use of non-study ablation catheter in the index procedure or in a repeat
procedure during the blanking period
* More than one repeat procedure during the blanking period (90 days post index
procedure)
* Surgical ablation of Atrial Fibrillation (AF)/Atrial Tachycardia (AT)/Atrial
Flutter (AFL) post index procedure
* Documented atrial fibrillation, or new onset of atrial flutter or atrial
tachycardia between 91 days and 183 days post index procedure captured by one
of the following methods:
o * 30 seconds in duration recording from the study specific event monitor or
Holter Monitor
o * 10 seconds 12-lead Electrocardiography (ECG)
* Any of the following interventions for atrial fibrillation, or new onset of
atrial flutter or atrial tachycardia between 91 days and 183 days post index
procedure:
o Repeat procedure
o Electrical and/or pharmacological cardioversion
o Prescribed any AAD
Primary Effectiveness Endpoint at 12 Months
This primary effectiveness endpoint at 12 months is defined as the primary
effectiveness event-free rate at 12 months post-procedure.
Secondary outcome
Secondary Endpoints include the following:
* Secondary Safety Endpoint * SAE and AE Rates
* Secondary Effectiveness Endpoint 1 * New or Increased Dose of AAD
* Secondary Effectiveness Endpoint 2 * Single Procedure Success defined as
freedom from primary effectiveness failure without a repeat procedure
* Secondary Effectiveness Endpoint 3 * Symptomatic Recurrence: freedom from
documented symptomatic AF/AT/AFL recurrence
Other additional endpoints and analysis include, but are not limited to:
* Changes in the quality of life measures (AFEQT and EQ-5D-5L) between baseline
and 12 months follow up
* Total RF time for the index procedure (defined as the summation of all RF
application durations)
* Total number of RF applications
* Total fluoroscopy time for the index procedure
* Total index procedure time
* Freedom from recurrence of individual types of atrial arrhythmias between 91
and 365 days from index procedure: 1) AF 2) AT 3) AFL
* Freedom from cardiovascular hospitalization at 12 months
* Quantification of parameters used during RF Application including RF power,
RF duration, contact force and Local Impedance via DIRECTSENSE* technology
* Descriptive summaries of primary safety and effectiveness endpoints at 12
months using the data available at the time of the 6-month analysis
* The predicted probability of success for the primary effectiveness endpoint
at 12 months based off the data available at the time of the 6-month analysis.
Background summary
Atrial fibrillation (AF) is the most commonly encountered sustained cardiac
arrhythmia in clinical practice. It currently affects approximately 2.3 million
people in North America and 4.5 million people in Europe. In addition, the
prevalence and incidence of AF are increasing over time due to the aging of the
population and a substantial increase in the age-specific occurrence of AF.
AF causes symptoms that impair quality of life, increases the risk of stroke
fivefold and also increases mortality. There are multiple therapies in current
use for the treatment of AF; however, it is recognized that many of these
therapies are suboptimal for most patients. Treatment options include medical
management, pacing, cardioversion, implantable devices, surgery, and ablation
therapy to eliminate the arrhythmia. It has been increasingly recognized that
focal pulmonary vein triggers of AF can account for 80 to 95 percent of
paroxysmal cases that are drug resistant. As outlined in the 2017 Heart Rhythm
Society (HRS) consensus document, *electrical isolation of the PVs is now
recognized as the cornerstone of AF ablation. At most centers where AF ablation
is performed, a strategy of creating a series of point-by-point radiofrequency
lesions that encircle the PVs is used.*
In the current clinical state of the art, power, time, and tissue contact are
monitored to balance the formation of effective transmural lesions with the
risk of adverse effects (cardiac perforation, steam pops, and thrombus
formation). When using conventional ablation catheters, like the predecessor
catheters, tissue contact is determined by surrogate parameters like tactile
feel, generator impedance, intracardiac electrogram amplitude, catheter
position on a visualization system relative to the anatomy or using ancillary
products like intracardiac echo. Catheter to tissue contact has been shown to
be a determinant of individual lesion dimensions and adverse events (i.e. steam
pop, thrombus or char) via ex vivo tissue preparations and in vivo pre-clinical
studies were incorporated into the distal tip of cardiac ablation catheters.
With the introduction of force sensing catheters, physicians gained access to
additional feedback on the mechanical coupling between the catheter tip and
tissue which provides additional feedback for consistent RF application. The
use of contact force is now a mature, state of the art technology for open
irrigated ablation with several years of clinical experience, holding great
potential for improving the safety and success rates of AF ablation procedures
by reducing suboptimal and excessive CF during ablation.
Boston Scientific (BSC) has developed the IntellaNav* StablePoint Catheter, an
8.5F compatible, steerable, open irrigated, radiofrequency ablation catheter
with multiple diagnostic electrodes that leverages the existing BSC OI platform
and incrementally provides the ability to measure a force applied to the distal
tip. The catheter is designed to incorporate force-sensing elements while
preserving the core therapeutic functionality of the prior Blazer* OI family of
catheters (including both Blazer* Open-Irrigated and IntellaNav* Open-Irrigated
[BOI-NOI]) relative to RF delivery, cooling performance, and maneuverability
within the cardiac environment.
In addition to the contact force sensing capability, the IntellaNav*
StablePoint Catheter is also enabled to measure Local Impedance via
DIRECTSENSE* technology. Local Impedance is a measure of the impedance
properties closest to the catheter distal electrode that allows for a
diagnostic metric that can be used in conjunction with other clinical measures
to inform the physician on catheter proximity relative to cardiac tissue and
resistive heating directly under the ablation electrode of the catheter. Local
impedance measured at the ablation catheter tip has been shown to provide a
superior method of assessing catheter-tissue coupling compared to generator
impedance in both preclinical and clinical settings. Additionally, a strong
correlation has been demonstrated between local impedance drop and lesion
formation preclinically (in vitro and in vivo), and in the clinical setting via
pace capture. Tissue temperature changes due to local heating with application
of radiofrequency (RF) energy during catheter ablation results in decreasing
local electrical resistivity surrounding the RF electrode and a characteristic
decrease in local impedance. Monitoring electrode impedance changes via the
ablation generator can provide real-time feedback on the tissue response to RF
ablation.
Both contact force sensing and local impedance capabilities implemented in the
StablePoint Catheter may concur to improve ablation procedures as their
complementary use can provide an advantage over the use of one metric alone.
When studying the complementary nature of the two features with discrete
lesions in vitro and in vivo, it resulted that the confirmation of stable
mechanical contact and viewing of real-time local impedance drops enabled a
significant reduction in RF time while creating a continuous linear lesion.
The IntellaNav StablePoint Catheter System includes the IntellaNav StablePoint
Catheter and Cable, the Maestro Force Sensing Connection Box and the Force
Computation Software Module. When used with the Rhythmia HDx* Mapping System
with Software 4.0.1 or greater and the BSC Cardiac Ablation System, the Force
Sensing System can be used for treatment of drug refractory, recurrent,
symptomatic Paroxysmal Atrial Fibrillation. The catheter system is based on
BSC*s Blazer* Open-Irrigated and IntellaNav* Open Irrigated ablation catheter
platform. This platform has been investigated in the BLOCk-CTI and ZERO AF
clinical trials and have demonstrated safe and effective use.
The IntellaNav StablePoint Catheter System received CE mark on June 5, 2020 and
will be commercially available in geographies that accept CE mark.
Study objective
To demonstrate the safety and effectiveness of the IntellaNav StablePoint
Catheter and Force Sensing System with DIRECTSENSE for treatment of drug
refractory, recurrent, symptomatic Paroxysmal Atrial Fibrillation (PAF).
Study design
The NEwTON AF study is a multi-center, global, prospective, single arm study to
establish the safety and effectiveness of the IntellaNav StablePoint Catheter
and Force-Sensing System in subjects with symptomatic, drug refractory,
recurrent paroxysmal atrial fibrillation. The study will be conducted in North
America, Europe and Asia Pacific. A 6-month endpoint analysis is planned and
will be conducted after all 299 TREATMENT subjects have completed 30 days of
follow up and 183 TREATMENT subjects have completed their 6-month follow-up. If
effectiveness is not demonstrated at the 6-month endpoint analysis, then it may
be re-evaluated at the 12-month endpoint analysis. All subjects undergoing the
index procedure with the study devices will be followed up to 12 months.
Study burden and risks
Risks associated with an ablation procedure. Risks associated with the RF
ablation procedure do not differ from the standard ablation procedure.
Lambroekstraat (Green Square) 5D
Diegem 1831
BE
Lambroekstraat (Green Square) 5D
Diegem 1831
BE
Listed location countries
Age
Inclusion criteria
* History of recurrent symptomatic Paroxysmal Atrial Fibrillation (PAF),
defined as atrial fibrillation (AF) that terminates spontaneously or with
intervention (either procedure or drug therapy) within seven days of onset.
Minimum documentation includes the following:
o a physician*s note indicating recurrent self-terminating atrial fibrillation
(AF) which includes at least two symptomatic AF episodes in the patient*s
history within the last 6 months prior to enrollment, and
o any electrocardiographically documented AF episode within 12 months prior to
enrollment.
* Subjects who are eligible for an ablation procedure for PAF according to 2017
HRS expert consensus statement on catheter ablation of atrial fibrillation;
* Subjects refractory or intolerant to at least one class I or class 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
associated with this clinical investigation at an approved clinical
investigational center;
* Subjects whose age is 18 years or above, or who are of legal age to give
informed consent specific to state and national law.
Exclusion criteria
* Subjects with New York Heart Association (NYHA) Class III or IV heart failure
< 180 days prior to enrollment
* Left atrial diameter > 5.0 cm or left atrial volume >50 ml/m² indexed based
on the most recent echocardiography
* Left ventricular ejection fraction < 35% based on the most recent
echocardiogram
* Continuous AF lasting longer than seven (7) days
* Subjects who have undergone any previous left atrial cardiac ablation (RF,
Cryo, surgical)
* Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or
reversible or non-cardiac cause
* Subjects who have undergone any cardiac ablation or any surgery within 30
days prior to enrollment
* Currently implanted with a pacemaker, ICD, CRT device, or an implanted
arrhythmia loop recorder
* Active systemic infection
* Unstable angina or ongoing myocardial ischemia
* Myocardial Infarction (MI) within 90 days prior to enrollment
* Evidence of myxoma, left atrial thrombus or intracardiac mural thrombus
* Previous cardiac surgery (i.e. ventriculotomy, atriotomy, CABG, PTCA, PCI,
coronary stenting procedures) * 90 days prior to enrollment.
* Severe valvular disease, including mechanical prosthetic mitral or tricuspid
heart valves (patients with successful mitral valve repair allowed * annular
ring constitutes repair);
* Any prior history of documented cerebral infarct, TIA or systemic embolism
[excluding a post-operative deep vein thrombosis (DVT)] <180 days prior to
enrollment
* Moderate or severe mitral stenosis (severity assessed on the most recent TTE
*180 days prior to enrollment. Defined as pulmonary artery systolic pressure
>30 mmHg)
* Presence of left atrial appendage closure device
* Interatrial baffle, closure device, patch, or patent foramen ovale (PFO)
occluder
* Subjects who, in the judgment of the investigator, have a life expectancy of
less than two (2) years
* Women of childbearing potential who are, or plan to become, pregnant during
the time of the study (method of assessment upon investigator*s discretion)
* Amiodarone use within 60 days prior to enrollment
* Any carotid stenting or endarterectomy
* Stage 3B renal disease or higher (estimated glomerular filtration rate, eGFR
<45 mL/min)
* Known coagulopathy disorder (e.g. von Willebrand*s disease, hemophilia)
* Any known contraindication to an AF ablation
* Any known contraindication for anticoagulation (e.g. patients unable to
receive heparin or an acceptable alternative to achieve adequate
anticoagulation)
* Vena cava embolic protection filter devices and/or known femoral thrombus
that prevents catheter insertion from the femoral approach
* Known sensitivity to contrast media (if needed during the procedure) that
cannot be controlled with pre-medication
* Rheumatic Heart Disease
* Presence of intramural thrombus, tumor or other abnormality that precludes
vascular access, or manipulation of the catheter
* Subjects unable or unwilling to complete follow-up visits and examinations
for the duration of the clinical study
* Subjects who are currently enrolled in another investigational study or
registry that would directly interfere with the current study, except when the
subject is participating in a mandatory governmental registry, or a purely
observational registry with no associated treatments; each instance must be
brought to the attention of the sponsor to determine eligibility.
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 | NCT04580914 |
| CCMO | NL79342.100.21 |