We hypothesize that PVAC GOLD is non-inferior to Single Tip catheter ablation with Contact Force sensor guided by 3-D mapping. This will be tested by comparing procedural characteristics and long term outcome with regard to safety, and effectiveness…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Effectiveness: Freedom of AF during 1 yr follow-up
Burden of AF
Safety: Serious Adverse Events during 30 days post-procedure
Secondary outcome
Effectiveness: Symptom reduction, procedure times, findings during redo
procedure
Safety: Serious adverse events during 1 yr follow-up
Background summary
As ablation is increasingly in demand for invasive treatment of AF, there is a
need for new efficient and safe techniques. Multi-electrode ablation may
provide such a method. Currently, there are 2 techniques available, with a few
cardinal differences. PVAC GOLD is a relatively simple and quick, but does not
use high power irrigated RF energy nor 3-D mapping to guide ablation like the
more complex Single Tip catheter with Contact Force sensor guided by 3-D
mapping. It is unknown whether despite their differences, both systems are as
safe and efficient, with similar long term efficacy.
Study objective
We hypothesize that PVAC GOLD is non-inferior to Single Tip catheter ablation
with Contact Force sensor guided by 3-D mapping. This will be tested by
comparing procedural characteristics and long term outcome with regard to
safety, and effectiveness: curative treatment leading to freedom of AF
Study design
Multicenter randomized clinical trial in patients with AF accepted for PV
ablation
Intervention
Group 1: PVI ablation using PVAC GOLD catheter
Group 2: PVI ablation using irrigated Single Tip catheter
Study burden and risks
All patients will undergo ablation according to local protocol.
All pts will receive additional pre-procedure transesophageal echo. All pts
will receive two 7-day Holter recordings. Depending on local standards or
standardized care (Meetbaar Beter), many pts may receive such follow-up anyway.
The added risk of these tests is negligible. The TEE will probably be most
demanding, but is performed to exclude intracardiac thrombus.
Koekoekslaan 1
Nieuwegein 3435CM
NL
Koekoekslaan 1
Nieuwegein 3435CM
NL
Listed location countries
Age
Inclusion criteria
Symptomatic Atril Fibrillation, refractory to anti-arrhythmic drugs, with a guideline indication for ablation
Exclusion criteria
prior ablation, dilated atria, prior stroke, significant structural disease requiring invasive treatment, valvular repair/replacement
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 | NCT02463851 |
| CCMO | NL49603.100.14 |