This prospective, randomized, controlled, unblinded, multicenter study aims at comparing procedural time between conventional CLOSE-guided PVI (35W/50W) versus very high power radiofrequency delivery (90W) in AF patients scheduled for a first PVI.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Procedural time
Secondary outcome
• Efficiency: fluoroscopy time, RF ablation time, fluoroscopy dose, first pass
isolation rate
• Efficacy: single procedure freedom from ATA during month 4, 5 and 6 after
index ablation
• Safety: serious adverse events
Background summary
The QDOT-MICRO* (Biosense Webster Inc., Irvine, CA, USA) is CE-marked for both
conventional and for very high power/short duration ablation to treat atrial
fibrillation
Study objective
This prospective, randomized, controlled, unblinded, multicenter study aims at
comparing procedural time between conventional CLOSE-guided PVI (35W/50W)
versus very high power radiofrequency delivery (90W) in AF patients scheduled
for a first PVI.
Study design
This is a prospective, randomized, controlled, unblinded, multicentric study.
Intervention
If deemed eligible for and willing to participate in the study, the patient or
legal representative must sign the informed consent form prior to study
enrolment. Patients will be randomized on a 1:1 ratio to the conventional group
(CLOSE-guided PVI with 35/50W RF delivery) or to the very high power short
duration RF delivery group (90W).
Study burden and risks
Patients will undergo catheter ablation for atrial fibrillation as clinically
indicated. After randomization, one of two ablation energy protocols will be
employed using the same access to the heart and the same (CE-marked) materials
to apply ablation at the same locations in the heart. Both energy protocols
have been evaluated in previous clinical studies and are currently applied by
operators in regular clinical practice based on their preference. Patients in
the very high power and short duration RF strategy group may have the benefit
of a shorter procedure. Patients will be followed after the procedure with
Holter monitoring as clinically indicated after ablation.
Ruddershove 10
Brugge 8000
BE
Ruddershove 10
Brugge 8000
BE
Listed location countries
Age
Inclusion criteria
• Age older than 18 years
• Being scheduled for a first PVI only for paroxysmal AF (self-terminating or
<7days) or persistent AF (persistent AF is defined as having an AF episode
>7d); (patients with paroxysmal AF or short-standing persistent AF presenting
with flutter, who are in need of a CTI ablation, are allowed to participate in
this trial)
• Patients willing to sign informed consent
Exclusion criteria
• Patients with long-standing persistent AF (long-standing persistent AF is
defined as having an AF episode >1yr)
• Previous ablation for AF
• AF secondary to electrolyte imbalance, thyroid disease, or reversible or
non-cardiac cause
• Left atrial thrombus. LAA thrombus can be determined by preprocedural
imaging: intracardiac echo, CT, TEE or MRI.
• Abnormal echocardiography defined by at least one of the following criteria
o Left ventricular ejection fraction <35%
o LA antero-posterior diameter >50 mm (parasternal long axis view, PLAX), if
known
• Cardiac surgery within the previous 90 days.
• Expecting cardiac transplantation or other cardiac surgery within 180 days.
• Coronary PTCA/stenting within the previous 90 days or myocardial infarction
within the previous 60 days.
• Documented history of a thromboembolic event within the previous 90 days.
• Women who are pregnant or who plan to become pregnant during the study.
• Acute illness or active infection at time of index procedure
• Advanced renal insufficiency
• Unstable angina
• History of blood clotting or bleeding abnormalities.
• Contraindication to anticoagulation.
• Life expectancy less than 1 year.
• Presence of a condition that precludes vascular access.
• Unwilling or unable to provide informed consent.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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 | NCT04784013 |
| CCMO | NL77957.058.21 |