Primary Objective:To demonstrate that the AlCath Flux eXtra Gold ablation catheter is non-inferior compared to historical datafrom the literature regarding the prevention of new subclinical cerebral thromboembolic lesions after PVI.Secondary…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The occurrence of one or more new subclinical cerebral TE lesions after PVI
assessed by Diffusion-Weighted MRI.
Secondary outcome
To assess the impact of PVI on the patient*s neurocognitive status.
Endpoint: Neurocognitive score
To assess the incidence of peri-procedural serious adverse events.
Endpoint: Any serious adverse event occurring during the ablation procedure and
within 24 hours from completion of the procedure.
To assess the incidence of post-procedural clinical Thromboembolic events (TE).
Endpoint: Composite endpoint: Occurrence of Transient Ischemic Attack and/or
Ischemic Stroke and/or Systemic Embolism during the three months post-ablation
period (excluding peri-procedural events).
To assess the acute procedural success rates of PVI.
Endpoint: Acute procedural success of PVI, defined as electrical isolation of
all Pulmonary veins.
To collect procedure and ablation related data regarding PVI.
Endpoints: Delivered Radio Frequency (RF) power during PVI, Number of RF
applications for PVI,Total duration of RF application and delivered energy for
PVI, Occurrence of audible steam pops during PVI, Total procedure time (from
first puncture to obtain vascular access to removal of the
last catheter), Left atrial procedure time (from first left atrial access to
removal of all catheters and sheaths from the left atrium)
To assess the rate of success of PVI at three months.
Endpoint: Three months ablation success, defined as freedom from symptomatic AF
recurrences off antiarrhythmic drug therapy assessed to three-month follow-up.
Background summary
Pulmonary Vein Isolation (PVI) is a commonly performed catheter ablation
procedure for treatment of patients with symptomatic atrial fibrillation (AF).
The procedure is aimed at electrical isolation of the pulmonary veins by the
creation of circumferential lesions around the right and left pulmonary Vein
(PV) ostia. Successful PVI prevents the recurrence of AF by eliminating AF
triggers located within the PV ostia and altering the
arrhythmogenic substrate near the atrial-PV junction.. Current clinical
guidelines recommend catheter ablation for patients with symptomatic paroxysmal
or persistent AF in whom antiarrhythmic drug therapy fails to sufficiently
suppress AF recurrences and associated symptoms.
Radio-frequency (RF) ablation utilizes RF energy that is delivered through an
ablation catheter to the tissue targeted for ablation. By achieving high local
current densities within the target tissue a heat-induced lesion is created.
Open irrigation is a technology to cool the ablation tip during RF application,
reducing char and the risk of heat coagulation at the tip and possible
embolization of coagulum. Thereby it reduces the risk of thromboembolic (TE)
complications associated with the application of RF energy. Recent
technological developments are aimed at improving the cooling effect by the use
of novel electrode materials and an optimized configuration of
the irrigation holes.
Peri-procedural thromboembolism is one of the most significant complications of
catheter ablation. In a 2010 survey covering more than 20 000 catheter ablation
procedures, stroke and Transient Ischemic Attack (TIA) were observed in 0.23%
and 0.71% of the procedures, respectively. Besides symptomatic TE events,
cerebral thromboembolism may also occur without any acute clinical symptom.
Silent cerebral thromboembolic
lesions, resulting from asymptomatic thromboembolism are usually identified by
cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), which is
highly sensitive to acute ischemic injury. Recent literature reports on an
incidence of PVI associated silent cerebral embolism detected by DW-MRI between
7.4% and 14%.
Until now, no association has been demonstrated between silent cerebral
embolism and neurocognitive impairment. Most silent cerebral lesions observed
acutely after ablation may disappear at later follow-up (> 2 weeks
post-ablation) and heal without scarring.
Although the impact of silent cerebral embolism on neurological functioning is
not demonstrated it is considered a serious issue and reduction of its
incidence is desirable.
The REDUCE-TE Pilot study will assess the incidence and neurological
consequences of silent cerebral thromboembolism after PVI conducted according
to insights and recommendations from guidelines and expert consensus.
Furthermore, the study will test the hypothesis that an innovative design and
material of the RF ablation electrode, aimed at optimal electrode cooling, will
have no higher incidence of silent cerebral
thromboembolism compared to historical data from the literature using irrigated
standard catheters (Thermocool, Biosense Webster; Coolpath, St. Jude; Sprinklr,
Medtronic).
Study objective
Primary Objective:
To demonstrate that the AlCath Flux eXtra Gold ablation catheter is
non-inferior compared to historical data
from the literature regarding the prevention of new subclinical cerebral
thromboembolic lesions after PVI.
Secondary objectives:
To assess the impact of PVI on the patient*s neurocognitive status with the
AlCath Flux eXtra Gold catheter.
To assess the incidence of peri-procedural serious adverse events of patients
for PVI with the AlCath Flux eXtra Gold catheter.
To assess the incidence of post-procedural clinical TE events with the AlCath
Flux eXtra Gold.
To assess the acute procedural success rates of PVI with the AlCath Flux eXtra
Gold catheter.
To collect procedure and ablation related data regarding PVI with the AlCath
Flux eXtra Gold ablation catheter.
To assess the rate of three months success of PVI with the AlCath Flux eXtra
Gold ablation catheter.
Study design
International, multicenter, prospective, single arm, pilot study,
Study burden and risks
The associated risk with a PVI ablation is not study specific and not different
from risks associated with a standard PVI ablation.
The risks associated with study specific diagnostic procedures MRI,
Transoesofagale Echography (TEE) or Intracardiac Echography (ICE - if TEE not
possible) and neurological questionaires and tests are described in the
protocol section 6.2.
To minimize the risks from these diagnostic procedures, subjects with a
contraindication for TEE and/or MRI are excluded from the study. The patient
must also give prior written consent if he/she wants to be informed about any
additional clinically relevant finding seen on the MRI.
No additional risks are expected from the neurological questionnaires and
tests.
Woermannkehre 1
Berlijn 12359
DE
Woermannkehre 1
Berlijn 12359
DE
Listed location countries
Age
Inclusion criteria
* sympotomatic paroxysmal atrial fibrillation (AF)
* indication for left atrial ablation for AF according to ESC guidelines
* Anticoagulation according to clinical routine using coumarin derivates with a target INR between 2.0 and 3.0 for at least 3 weeks prior to the scheduled ablation procedure or novel oral anticoagulants (NOACs).
* geographically stable during the study
* patient is willing and able to provide written informed consent
Exclusion criteria
* < 18 years
* Long standing persistent or persistent Atrial Fibrillation
* CHA2DS2-VASc score >= 5
* Prior ischemic stroke or Transient Ischemic Attack
* Previous PV ablation
* Contraindication for antigoagulation therapy
* Contraindication for Diffusion-Weighted MRI
* Claustrophobia
* Contraindication for transesophageal echocardiography (TEE) or intracardiac echography (ICE, if TEE not possible)
* Implanted cardiovascular device
* Acute coronary syndrome < 3 months prior to scheduled ablation
* Moderate to severe valvular heart disease
* LA size > 55 mm
* non-controlled heart failure or current and recent heart failure (< 1 month prior to ablation)
* Ejection fraction < 35%
* Conditions that prevent patient*s participation in neurocognitive assessment
* Female patients who are pregnant or breast feeding
* footnote: ferromagnetic implants without approval for MRI investigations at the respective MRI unit.
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 | NCT02275260 |
| CCMO | NL51329.100.14 |