The purpose of the study is to determine the rate of DW-MRI cerebral lesions following a PVAC ablation procedure performed using best practices, including optimized procedural techniques and anti-coagulation therapy.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Demonstrate that use of best PVAC ablation practices, will reduce the cerebral
lesion rate to less than the published rate of 38%.
Secondary outcome
The key secondary objectives are intended to provide additional information on
the performance of the GENius* Multi-Channel RF Generator. There will be no
established performance requirements related to these secondary objectives
required. The secondary objectives are as follows:
• Assess the use of best practices during PVAC® ablation and the rate of major
or minor complications.
• Characterize the use of best practices during PVAC® ablation to reduce
cerebral lesion rates will not negatively affect acute efficacy.
• Collect high resolution generator data to develop a validation database to
test future algorithms for automatic detection of microemboli.
Background summary
Various studies have reported on a varying incidence rate for DW-MRI findings
post ablation procedures in both acute and chronic patients . These studies
involved different operators and did not control the procedural techniques and
the anticoagulation strategy. Animal studies have uncovered different causes
for micro-emboli creation during an ablation procedure using a PVAC and methods
to prevent them. Medtronic AF Solutions needs to characterize the baseline
rate and time course (acute/chronic) of DW-MRI cerebral lesions in a
multicenter trial, when a common PVAC ablation procedure and anticoagulation
strategy is followed.
Study objective
The purpose of the study is to determine the rate of DW-MRI cerebral lesions
following a PVAC ablation procedure performed using best practices, including
optimized procedural techniques and anti-coagulation therapy.
Study design
The ERACE Study is a prospective multi-center, non-randomized, single arm,
feasibility study designed to provide characterization of the baseline rate of
DW-MRI cerebral lesions during a common PVAC® ablation, and to characterize the
effect of procedural techniques and anti-coagulation therapy and cerebral
lesions in patients undergoing an ablation procedure. Study data shall be
collected at the time of the procedure, 1-3 days following the procedure, and 1
month follow-up.
Intervention
Subject will be prepared for surgery as normal for standard PVAC ablation
procedures, which includes administration of anesthesia/analgesia, ECG and BP
monitoring.
Fit subject with transcranial Doppler system to measure cerebral emboli during
procedure (OPTIONAL)
Turn on the GENius generator and set up the notebook computer for serial port
data recording.
Draw a baseline ACT
Place an ICE catheter in the right atrium (OPTIONAL)
Inject heparin bolus immediately before or immediately following transseptal
puncture
Following puncture, wait until ACT level is > 350 sec before performing any
ablations within the left atrium.
Follow immersion loading technique for PVAC into sheath
Ablation
At end of procedure, inspect PVAC electrodes for signs of coagulum
Return catheter to Medtronic Ablation Frontiers.
Study burden and risks
The potential risks to a subject participating in this study are believed to be
similar to those encountered during PVAC ablation procedures. Additional risks
include, but are not limited to, the following:
Possible adverse events that can occur during and after an MRI include but are
not limited to the following:
• Feelings of claustrophobia
• Temporary hearing loss due to the loud noise
• Stiffness due to lack of movement
• Mild lightheadedness
• Sweating due to the heat from the MRI machine
• Warm body sensation after the exam is done
There may be additional risks related to study participation that are unknown
at this time. Subjects will be closely observed throughout the duration of the
testing and recovery period to identify any adverse events.
8200 Coral Sea Street NE
55112 Mounds View, MN
US
8200 Coral Sea Street NE
55112 Mounds View, MN
US
Listed location countries
Age
Inclusion criteria
Subject is at least 18 years old
Subject has been diagnosed with atrial fibrillation (AF)
Subject is indicated for a pulmonary vein ablation using PVAC
Subject (or subject*s legally authorized representative) is able and willing to give informed consent
Exclusion criteria
Subject has permanent AF
Subject has a left atrial thrombus detected on TEE
Subject has had a prior left atrial ablation
Subject has an intracardiac thrombus
Subject is contraindicated for Warfarin (Coumadin)
Subject has a cardiac valve prosthesis
Subject has a significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)
Subject has presence of any pulmonary vein stents
Subject has presence of any pre-existing pulmonary vein stenosis
Subject has had a cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date
Subject will undergo additional left atrial ablations with catheters other than a PVAC.
Subject is a woman known to be pregnant
Subject is unable or unwilling to participate with study procedures
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 | NCT01520532 |
| CCMO | NL39050.100.12 |