The primary objective of this study is to characterize low-voltage substrate, as identified via HD Wave mapping in sinus rhythm and identify associations with 12-month recurrence rates after a single pulmonary vein isolation with a contact force RF…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is one-year success, defined as freedom from AF/AFL/AT
after removal from antiarrhythmic drug therapy as assessed from the end of the
3-month blanking period to 12 months following a single ablation procedure.
Secondary outcome
See page 13 and 14 of the protocol (versie A, 20 februari 2019).
Acute procedural success, defined as electrical isolation of all pulmonary
veins.
Success post blanking period through 12 months using different definitions,
including:
-Freedom from symptomatic AF/AFL/AT after removal from AAD therapy
-Single procedure clinical success defined as freedom from symptomatic
AF/AFL/AT without a new or increased dose of class I or III AAD
-Freedom from AF/AFL/AT
Data from EnSite maps using both HD Wave and Standard mapping modes in both
sinus rhythm and AF including but not limited to:
-Left atrial area using different boundaries (e.g. with and without LAA,
etc.)
-Low voltage area and proportion of left atria with low voltage using
different thresholds for low voltage
Rates of recurrence not due to PVI gap for subjects with repeat
electrophysiology studies
LA volume and diameter
Adverse events including any device-, procedure-, or death-related events
Other baseline characteristics including but not limited to:
-Time with AF
-Type of AF
-Sex / BMI
-General medical history / Cardiovascular history / Arrhythmia history
-NYHA classification / LVEF
-Presence of pacemaker
Procedural characteristics, including but not limited to:
-Power, temperature, and contact force
-Procedure time / Mapping time / Fluoroscopy time
-Cardioversions (if applicable)
-Anesthesia
Background summary
This study will provide insight into how substrate characteristics, as measured
by GRID, can identify subjects who will not benefit from additional substrate
modification beyond PVI. This may result in future recommendations for
treatment based on HD Wave mapping of baseline substrate so that additional,
unnecessary ablations along with their potential risks can be avoided. There
have been no studies to date correlating substrate characteristics, as measured
using HD Wave mapping, to outcomes. Results of this study may also help design
future studies on GRID to further investigator treatment algorithms for atrial
substrate modification in AF.
Study objective
The primary objective of this study is to characterize low-voltage substrate,
as identified via HD Wave mapping in sinus rhythm and identify associations
with 12-month recurrence rates after a single pulmonary vein isolation with a
contact force RF ablation catheter.
Other objectives of this study include:
* Analyze additional maps and data collected with GRID and associations with
12-month recurrence rates, such as:
o Voltage maps using different configurations recreated post procedure
o Voltage maps using different thresholds for low-voltage
o Fractionation maps
* Collect mapping data in AF to support future research and development.
* Support future study designs to identify optimal treatment approaches for
individual patients.
Study design
This is a single-arm, multicenter, post-market study. There will be no
randomization. The purpose of the study is to determine correlations between
low-voltage substrate, as identified via HD Wave mapping, and recurrence of
atrial fibrillation after a single pulmonary vein isolation with a contact
force RF ablation catheter.
Study burden and risks
The risk of participation is minimal. The burden may be higher for procedures
where sedation or anesthesia is being administered. The accompanied risks may
be higher due to potentially longer mapping times.
Because fluoroscopy is being used to control the cardiac mapping procedures and
ablation procedure, a potentially longer mapping procedure can expose the
subject to more X-rays. The total risk of this dose is considered small.
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Listed location countries
Age
Inclusion criteria
1. Documented atrial fibrillation with planned endocardial ablation procedure
2. Age 18 years or older
3. Able and willing to provide written informed consent prior to any clinical
investigation related procedure
4. Able and willing to complete all required study procedures through 12 months
Exclusion criteria
1. Long-standing persistent atrial fibrillation defined as continuous AF
greater than 12 months in duration
2. Previous ablation or surgery in the left atria
3. Implanted left atrial appendage occluder
4. Implanted mitral or tricuspid valve replacement
5. Implanted cardiac defibrillator (ICD)
6. Participation in another clinical investigation that may confound the
results of this study
7. Pregnant or nursing
8. Presence of other anatomic or comorbid conditions, or 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.
9. Life expectancy less than 12 months
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 | NCT03882021 |
| CCMO | NL70507.042.19 |