The purpose of this clinical study is to evaluate asymptomatic cerebral embolic (ACE) in subjects with symptomatic paroxysmal atrial fibrillation (AF) undergoing ablation with the Pulmonary Vein Ablation CAtheter GOLD (PVAC GOLD).(See also p. 13 of…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Report rate of ACE (number of subjects presenting with post-procedural
asymptomatic cerebral embolic lesions as determined by MRI)
Secondary outcome
The Secondary study objectives are:
- Characterize Acute procedural success
--> Acute procedural success will be defined as: only PVAC GOLD catheters(s)
used to achieve pulmonary vein isolation AND all accessible
pulmonary veins were isolated (entrance block) AND sinus rhythm is
restored at the end of the ablation procedure (with or without
cardioversion)
- Report procedure and device related serious adverse event rate
--> Summarize all procedure and/or device related serious adverse events
using PVAC GOLD within 30 days of an ablation procedure.
The ancillary study objectives are:
- Report PVAC GOLD procedure times
Report procedure times including total time, total fluoroscopy time, time spent
in Electrophysiology (EP) lab/Operating Room (OR), LA dwell time, total energy
delivery time.
- Report procedure details
• Number of energy applications per vein
• Energy modes used
• Electrodes turned off/on
- Report cumulative RF energy delivered
- Summarize results of MMSE
- Summarize adverse events
Background summary
Phased RF ablation of the pulmonary vein is an approved treatment for
paroxysmal, persistent, and permanent atrial fibrillation in Europe. The
Medtronic CE-Marked PVAC is a multi-electrode catheter used to map, ablate, and
verify isolation of the PVs. In combination with the GENius generator, this
phased array system can deliver radiofrequency (RF) energy to isolate PVs via
creation of circumferential lesions. PVAC GOLD is a line extension of PVAC with
three design modifications. Pre-clinical studies have demonstrated that the
design changes do not affect the safety and efficacy. The study was designed to
characterize the ACE (asymptomatic cerebral embolism) rate using PVAC GOLD.
(See also page p. 12 and p. 13 of the CIP: 2. Background and Justification)
Study objective
The purpose of this clinical study is to evaluate asymptomatic cerebral embolic
(ACE) in subjects with symptomatic paroxysmal atrial fibrillation (AF)
undergoing ablation with the Pulmonary Vein Ablation CAtheter GOLD (PVAC GOLD).
(See also p. 13 of the CIP: 1.1: Study Purpose)
Study design
PRECISION GOLD is a, prospective multi-center, single arm, unblinded,
interventional postmarket clinical study designed to evaluate PVAC GOLD with
regard to acute subject outcomes including, evaluation of the post-procedural
ACE rate, acute procedural success and assessment of procedure and/or device
related serious adverse events.
Intervention
The following information is required to be collected at the ablation procedure
or within specified timeframe prior to the ablation procedure:
• MRI scan (FLAIR and diffusion weighted) within 48 hours prior to procedure
• Concomitant medications and anticoagulation use
• TEE to rule out left atrial thrombus (within 48 hours of procedure)
• INR (required to be >= 2 on the day of procedure; if between 1.8 and 2.0,
subject required to be treated with heparin or low molecular weight heparin
within 4 hours post-procedure until INR is >= 2)
Procedure preparation
• Inject heparin bolus immediately before and/or immediately following
transseptal puncture.
• Administer heparin bolus and start continuous heparin infusion to maintain
ACT >=350 seconds throughout the procedure.
• Check ACT levels until target level of 350 seconds is reached.
• Do not ablate with the PVAC GOLD catheter unless ACT levels are at or above
350 seconds.
• Continue to measure ACT every 15-30 minutes throughout the procedure, until
PVAC GOLD is removed from the body.
PVAC GOLD catheter introduction
• Follow catheter introduction and use instructions described in the
instructions for use
• It is recommended to capture the spiral array in the capture device while
submerged in a saline and/or heparinized saline bath
• It is recommended to vigilantly flush and/or aspirate the sheath to exclude
air ingress.
PVAC GOLD pulmonary vein ablation
• Follow instructions described in the catheter instructions for use and
generator operator manual
• Map for pulmonary vein potentials
• Verify isolation of the pulmonary veins after 30 minutes
Study burden and risks
There are possible risks and inconveniences in connection with the use of the
device PVAC® GOLD, followed procedures and with the participation in the study.
Since the procedure is not an experimental one, the risks and inconveniences
associated with the procedure are the same as if the patient were not in this
study.
The PVAC GOLD is inserted through a minimally invasive procedure. These side
effects may occur which are known for such procedures. For instance,
complications due to anesthesia, infection, bleeding, worsening of existing
symptoms and complications in the healing can occur. Moreover, some unexpected
side effects.
Hereunder are listed the possible risks or side effects that can occur during
and after an MRI. These potential risks associated with the MRI are the same as
those for any patient who undergoes an MRI:
• 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
• Feelings of claustrophobia (fear of enclosed spaces)
8200 Coral Sea Street N NE
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US
Listed location countries
Age
Inclusion criteria
Subject has Symptomatic paroxysmal AF defined as :
- Episodes of AF
- >=2 recurrent AF episodes that self-terminate, lasting no more than 7 continuous days
or
- episodes of AF <= 48 hours duration terminated with electrical or pharmacologic cardioversion
counts as a PAF episode
- Electrocardiographically documentation of one or more events with PAF (ECG, event recordings,
pacemaker strips or monitor rhythm strips) within the past year
- AF symptoms defined as the manifestation of any of the following: palpitations, fatigue,
exertional dyspnea, effort intolerance;Subject is on a Vitamin K antagonist (i.e. Warfarin/Coumadin)
Subject between 18 and 70 years old
Subject is indicated for a pulmonary vein ablation
Subject is able and willing to give informed consent
Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study.
Exclusion criteria
Subject has persistent or permanent AF
Subject has had a prior left atrial ablation
Subject has a intracardiac thrombus
Subject is contraindicated for Vitamin K antagonist (i.e. Warfarin/Coumadin)
Subject is prescribed to direct thrombin or factor inhibitors (i.e. Dabigatran, Rivaroxaban)
Subject prescribed any investigational drug that may confound the study results
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 pulmonary vein stents
Subject has 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 is a woman known to be pregnant
Participation in any other cardiovascular clinical study
Subject contraindicated for MRI
Subject has active sepsis
Subject has blood clotting abnormalities (genetic)
Subject has left atrial myxoma
Subject has a venous filtering device (Greenfield filter)
Subject has had an invasive cardiac procedure in the past 90 days
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 |
|---|---|
| CCMO | NL42569.100.12 |