This IDE trial is proposed herein to gather clinical data on the safety and effectiveness of a hybridsinus node sparing ablation procedure utilizing the AtriCure ISOLATOR Synergy Surgical AblationSystem to obtain an IST indication.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Effectiveness Endpoint
The primary effectiveness endpoint is freedom from IST at 12-months. Freedom
from IST is defined as mean heart rate of <= 90bpm or at least a 15% reduction
in mean heart rate as compared to baseline, in the absence of new or higher
dosage of previously failed medications.
Note:
• Mean heart rate will be collected using 7-day continuous monitoring
(baseline) and at 12months post procedure (follow-up) within the pre-specified
visit windows.
The primary safety endpoint for the study is defined as the incidence of device
or procedurerelated major adverse events (MAEs) for subjects undergoing the
hybrid sinus node sparing ablation procedure from the index procedure through
30-days post procedure
The following MAEs occurring within 30-days of the ablation procedure will
contribute toward the primary safety endpoint:
* Pericardial effusions with cardiac tamponade requiring surgical intervention
* Cardiovascular injury requiring surgical intervention
* Excessive bleeding requiring reoperation or 2 or more units of packed red
blood cells (PBRC) transfusion or results in >= 20% decrease in hematocrit
(HCT) within 30 days of index procedure)
* Pericarditis requiring surgical treatment (i.e., pericardiotomy)
* Permanent pacemaker implant (e.g., due to lack of sinus node recovery or
bradycardia <40bpm)
* New atrial arrhythmia as a result of the hybrid ablation procedure, requiring
intervention
* Infection at the surgical site requiring reoperation
The following MAE(s) occurring after 30 days of the procedure and lasting for
12-months will also contribute toward the primary safety endpoint:
* Permanent diaphragmatic paralysis
All MAEs will be adjudicated by the Clinical Events Committee (CEC), thus
maintaining the objectivity of the primary safety endpoint.
Secondary outcome
Key secondary effectiveness endpoints include, but may not be limited to:
* Change in 6-Minute Walk Test (6-MWT) from baseline compared to 6-, 12- and
24-months post-procedure
* Change in Borg dyspnea severity of breathlessness and fatigue score from
baseline compared to 6-, 12- and 24-months post-procedure. Borg dyspnea score
will be assessed at each of the 6-MWT
* Change from baseline in psychological evaluation compared to 6-, 12- and
24-months postprocedure utilizing the Self-Rating Anxiety Scale (SAS)
* IST symptom reduction at baseline, 6-, 12- and 24-months post-procedure
* Change in QoL based on a Short Form Survey (SF-12) domain and component
scores at baseline compared to 6-, 12- and 24-months post- procedure
* Change in mean heart rate at 6-, 12- and 24-months post-procedure compared to
baseline,using 7-day continuous monitoring
* Freedom from IST or at least 15% reduction in mean heart rate at 12- and
24-months compared to baseline, in the absence of rate control drugs
(beta-blockers/calcium channel blockers, ivabradine) and/or AADs
* Freedom from IST or at least a 15% reduction in mean heart rate at 12- and
24-months compared to baseline, regardless of rate control drugs (beta-
blockers/calcium channel blockers, ivabradine) and/or AADs
* Device or procedure related Serious Adverse Events (SAEs) through 12-months
* Improved heart rate variability for subjects using 7-day continuous monitoring
* Improved heart rate variability and activity levels for subjects with
implantable loop recorders (ILRs)
* Health Economics: ER visits and readmission
Background summary
Background
Inappropriate Sinus Tachycardia (IST) is a debilitating condition in otherwise
healthy patients,
resulting in a significant loss in quality of life. IST is characterized by an
elevated heart rate of
>100 bpm at rest with spikes of the heart rate well over the normal range
during mild exertion,
very mild stress or even while resting. When the body is under stress from
exercise, psychological
events or other internal and external stressors, it responds with an
exaggerated heart rate.
Clinical manifestations range from patients who are totally asymptomatic to
suffering
incapacitating, incessant tachycardia. Common complaints include palpitations,
lightheadedness,
pre-syncope, syncope, orthostatic intolerance, chest pain/pressure, dyspnea,
and exercise
intolerance (usually caused by issues with heart variability). Low heart rate
variability generally
indicates that the body is under stress from exercise, psychological events, or
other internal or
external stressors. Non-cardiac symptoms are frequent as well, such as anxiety,
depression,
abdominal discomfort, myalgia, insomnia, and headaches. No set criteria exist
for diagnosing
IST, therefore, it commonly is a diagnosis of exclusion, once other possible
causes of tachycardia
have been ruled out. As IST is the presence of a sinus tachycardia in otherwise
healthy patients,
the mechanism is different than for any other tachycardia. Mechanisms for IST
are believed to
amount to a form of dysautonomia, an intrinsic sinus node problem, or both.
However, a
consistent mechanism has yet to be identified.
Prevalence
IST occurs mostly in young females, and there is an associated emotional and
psychological
aspect which can cause severe distress and anxiety. Because IST is not always
recognized,
many patients are misdiagnosed with panic attacks and mental, or emotional
disorders. It is not
uncommon for them to be diagnosed with depression.
The estimates of IST prevalence vary from 1% to 1.2% of the general population.
Inappropriate Sinus Tachycardia Treatment
There are little evidence-based treatment options for IST. Drug treatments such
as beta blockers or calcium channel blockers are generally chosen as the first
line of treatment
but have not proven effective. Ivabradine, an inhibitor of the hyperpolarizing
sodium current,
is a more recent drug that has exhibited better results. Data has suggested
that a combination
of ivabradine and metoprolol might be safe and effective or Ivabradine may also
provide benefits
when added to a beta-blocker therapy.
Radiofrequency (RF) catheter ablation involving sinus node (SN) ablation has
been a potential
alternative in patients with IST refractory to medical therapy13. Often, the
symptoms worsen or
necessitate a permanent pacemaker. Other complications include phrenic nerve
damage or
transient superior vena cava syndrome. It is generally felt that the risks
involved outweigh the
benefit of this treatment.
Because of the complex psychosocial relationship to IST, treatment often
involves a multidisciplinary
approach. Managing the heart rate does not always relieve the distress the
patient has been experiencing1.
Other treatment options have included, erythropoietin, fludrocortisone, volume
expansion,
compression garments, phenobarbital, clonidine, psychiatric evaluation, and
exercise training.
Much like the treatment of Atrial Fibrillation, multi-disciplinary treatment
should only be sought for
symptomatic patients. For the treatment of IST, AtriCure is proposing a novel
procedure, whereby
a cardiac electrophysiologist (EP) and a cardiac surgeon (Surgeon) collaborate
in a single
procedure. The EP uses an endocardial mapping catheter to identify the location
of the sinoatrial
(SA) node, and the Surgeon uses AtriCure ablation devices to create a lesion
set designed to
reduce the heart rate while sparing the SA node. The SA node is a complex
structure in the heart
that is integral for the regulation of sinus rate. This procedure differs from
current forms of ablation
to treat IST performed by an EP alone, in which the SA node is modified or
excised. In addition,
AtriCure proposes that this novel procedure should only be considered after
lifestyle changes and
drug therapy have been administered and failed. This requirement coincides with
our discussions
with experts in the field and current Heart Rhythm Society (HRS) guidelines.
Rationale for Conducting this Clinical Investigation
IST is a prevalent and debilitating condition in otherwise healthy younger
patients, resulting in
significant loss of quality of life, lacking effective treatment options or
systematic clinical evidence
to support a therapy.
Study objective
This IDE trial is proposed herein to gather clinical data on the safety and
effectiveness of a hybrid
sinus node sparing ablation procedure utilizing the AtriCure ISOLATOR Synergy
Surgical Ablation
System to obtain an IST indication.
Study design
This is a prospective, multi-center, pivotal, single arm IDE trial sponsored by
AtriCure, Inc.
Intervention
Abblation for all included subjects.
Study burden and risks
The SA node is a complex and tightly controlled structure in the heart that is
integral for the regulation of sinus rate. Adverse events that may be
anticipated in this clinical trial are believed to be consistent with those
associated with other invasive surgical and cardiac procedures.
Complications may occur at any time during the procedure, post procedure or
follow-up period.
Possible adverse events may include, but are not limited to, the following:
AEs related to Device Only
Ablation or burns to non-target tissues
Atrial arrhythmia (needing ablation for typical atrial flutter, atypical right
atrial flutter, or ectopic atrial tachycardia)
Bradycardia
Junctional rhythm or an atrial escape rhythm (irreversible after hybrid
ablation procedure
New Arrhythmia other than IST (abnormal heart rhythm other than atrial
fibrillation)
Newly developed second- or third-degree AV block (interruption of heart rhythm)
requiring a permanent pacemaker
Pulmonary vein stenosis (narrowing of pulmonary veins that bring oxygen-rich
blood from the lungs back to the heart)
AEs related to Procedure Only
Air embolism (small amounts of air often get into the blood circulation)
Anesthesia risks
Aneurysm (a balloon-like bulge in an artery)
Asymptomatic cerebral embolism
Atelectasis (collapsed lung)
Cardiac tamponade (compression of the heart due to blood or fluid build-up in
space between the myocardium (the muscle of the heart) and the pericardium (the
outer covering sac of the heart)
Deep sternal wound if converted to sternotomy
Drug or Contrast Media Reaction (significant reaction to any medications
requiring treatment, including allergic reaction and anaphylactic shock)
[serious allergic reaction may include low blood pressure, trouble breathing,
seizures and death]
Endocarditis (an inflammation of the heart*s valves or inner lining)
Excessive pain and discomfort
Formation of unwanted scar tissue
Hemothorax (a collection of blood in the space between the chest wall and the
lung)
Hemorrhagic stroke secondary to anticoagulant therapy
Hypertension (high blood pressure)
Hypotension (low blood pressure)
Infection or fever
Myocardial Infarction (MI)
Persistent Chest Pain
Pneumonia (inflammation or infection of then lungs)
Pneumothorax (accumulation of air in the space between the lung and the chest
wall)
Post-surgical atelectasis (collapse of a lung)
Pseudoaneurysm (collection of blood within the wall of an artery)
Pulmonary Edema (fluid accumulation in the lungs)
Pulmonary embolism (blood clot in the lungs)
Radiation exposure (X-ray)
Reaction to contrast media/ medication (allergic reaction to X-ray dye or
medicine)
Renal insufficiency or failure (abnormal kidney function)
Respiratory distress or failure (breathing problems)
Vascular access site complications (complications in the area where the
catheter was inserted such as bruising, swelling, or vessel injury, including
the development of a hematoma, an AV fistula, or a pseudoaneurysm requiring
intervention such as surgical repair)
AEs related to both Device and Procedure
Arterial or venous dissection and/or perforation (a separation of the layers of
a blood vessel/a hole in the blood vessel)
Arterial rupture (a tear in the artery)
Atrial rupture (a tear in the upper chamber of the heart)
Bleeding (loss of blood, which may require a transfusion, conversion to
sternotomy or thoracotomy or another operation)
Cardiac Perforation (tear to your heart)
Cardiac Valve or Coronary Artery Injury (injury to a heart valve or heart
artery)
Cerebrovascular accident (Stroke) or other neurologic event (a stroke or *brain
attack* or other neurologic issue)
Chest pain/discomfort from port site or visceral pain from ablation
Damage to adjacent nerve and/or blood vessels
Death
Diaphragmatic paralysis (partial or stopped movement of your diaphragm,
resulting in difficulty breathing)
Emergency during the operation requiring change in the planned surgical access
(such as opening the chest through the breastbone)
Hematoma (a bruise)
Intercostal nerve injury
Ischemia (lack of blood flow and oxygen to a part of the body)
Pericarditis requiring pericarditis which could cause an effusion that leads to
hemodynamic compromise or requires pericardiocentesis or re-operation
Pericardial Effusion (an abnormal accumulation of fluid around the heart)
Phrenic nerve injury (temporary or permanent phrenic nerve paralysis)
Sepsis (a blood infection)
Significant Chest Wound Infection (requiring intervention and/or antibiotics)
Thoracotomy
Ventricular perforation or rupture (a hole in the ventricle)
Wound Infection at surgical site requiring re-operation for wound debridement
There may also be other risks that are unforeseen at this time.
The clinical investigation has been designed to involve as little pain,
discomfort, fear, and any other foreseeable risk as possible for subjects.
The risk associated with trial-required testing and assessments are summarized
in the table below. Although routine, these tests and assessments may be
performed at greater frequency than SOC practices.
History, Clinical Status, QoL, Surveys, 6-Min Walk & Physical Exam: Risks:
None, Minimal
Laboratory
testing:
Risks: Minimal. Usual risks associated with phlebotomy
ECG:
Risks: None, Minimal
echocardiography,
TTE:
Risks: None, Minimal
Computer tomography angiography
(CTA) Risks: A separate written
informed consent consistent with clinic policies and practices will occur
outside of trial
Innovation Way, 7555
Mason OH 45040
US
Innovation Way, 7555
Mason OH 45040
US
Listed location countries
Age
Inclusion criteria
1. Age >= 18 years and <= 75 years at time of enrollment consent
2. Subject has a diagnosis of IST:
a. Documentation of mean heart rate > 90bpm with 7-day monitor within 90 days
of the Index Procedure and;
b. Documentation of a resting heart rate of >100bpm and;
c. Documentation of presence of IST for at least 6-months
d. Documentation of absence of other tachycardia
e. Documentation of absence of secondary causes such as hormonal issues or
systemic illness that might contribute to increased heart rate
3. Documentation of refractoriness (intolerance or failure) of a drug (e.g.,
rate control drugs such as beta-blockers/calcium channel blockers, ivabradine),
and/or AADs
4. Subject is willing and able to provide written informed consent
Exclusion criteria
1. Subjects on whom cardiac surgery or single lung ventilation cannot be
performed
2. Subjects with indication for or existing ICDs/Pacemakers
3. Presence of channelopathies
4. Previous cardio-thoracic surgery
5. Left Ventricular Ejection Fraction (LVEF) < 50%
6. Body Mass Index (BMI) >= 35
7. Presence of supraventricular or ventricular tachycardia
8. Presence of Postural Orthostatic Sinus Tachycardia (POTS)
9. Presence of congenital heart disease
10. History suggestive of secondary cause of tachycardia such as
pheochromocytoma, anemia, thyrotoxicosis, chronic fever of unknown origin,
COPD, long-term bronchodilators use,
severe asthma or carcinoid syndrome
11. Subjects who have had a previous catheter ablation in the right atrium for
IST or other disorders;
Allowed catheter ablation in the right atrium:
a) One previous catheter ablation > 90 days prior to the Index
Procedure for AVRT or CTI
b) One previous catheter ablation > 180 days prior to the Index
Procedure for AVNRT
12. Life expectancy < 24 months
13. Pregnant or planning to become pregnant during trial
14. Subjects with substance abuse
15. Subjects with previous weight loss surgery
16. Subject is unwilling and/or unable to return for scheduled follow-up visits
17. Current participation in another clinical investigation of a medical device
or a drug, or recent participation in such a trial that may interfere with
trial results
18. Not competent to legally represent him or herself (e.g., requires a
guardian or caretaker as a legal representative) and;
19. 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
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 | NCT05280093 |
| CCMO | NL82643.068.22 |