The primary objective of this feasibility study is to demonstrate the initial safety and effectiveness of the CellFX® nsPFA* Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a more…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary safety endpoint is the rate of acute major adverse events (MAEs) which
includes death, stroke, myocardial infarction (MI), and transient ischemic
attack (TIA) or excessive bleeding (> 2units of blood and surgical
intervention) within 30 days post-ablation procedure.
Primary effectiveness is acute electrical isolation of the bilateral pulmonary
veins and left atrial Box by means of intraoperative entrance or exit block
testing
Secondary outcome
Safety
• Subjects presenting with Primary SAEs up to the 12-month post-procedure
follow-up
• Subjects presenting with any AEs or SAEs up to the 12-month post-procedure
follow-up
Effectiveness
• Long-term technical success is defined as confirmation of electrical
isolation of the bilateral pulmonary veins and left atrial Box by cardiac
electroanatomical mapping at 60-120 days following the index procedure
Background summary
Accompanying the aging of populations worldwide, and increased survival with
chronic diseases, the incidence and prevalence of atrial fibrillation (AF) are
rising, justifying the term global epidemic. Atrial fibrillation is the most
prevalent cardiac arrhythmia, with an estimated prevalence of 1.5-2.0%,
affecting approximately 2.5 million people in the United States and 4.5 million
in the European Union.
The incidence increases with advancing age, affecting 6% of the population over
age 60 and 10% of the population over age 80. Age-adjusted population trending
projects 16 million people in the United States will have AF and approximately
72 million globally by 2050. Atrial fibrillation remains a significant cause of
morbidity and mortality in industrialized societies. The annual risk of AF
related stroke is 5% per year and one of every six strokes diagnosed occurs in
the presence of AF.
Therefore, patients with AF require long-term anticoagulation to prevent
embolic events. Failure to manage AF may also lead to anatomic and electrical
remodeling of the left atrium, tachycardia-induced cardiomyopathy, and reduced
left ventricular function (heart failure).
Atrial fibrillation remains an extremely costly public health burden, with
annual per patient cost of care approaching ¤3000 (approximately U.S. $3200).
Study objective
The primary objective of this feasibility study is to demonstrate the initial
safety and effectiveness of the CellFX® nsPFA* Cardiac Clamp in performing a
box lesion around the 4 pulmonary veins as an isolated procedure or as a part
of a more extensive surgical ablation set in conjunction with concomitant
cardiac surgical procedure.
Study design
The study design is a prospective, multicenter, single arm, non-randomized,
feasibility study to evaluate the safety and effectiveness of the CellFX®
nsPFA* Cardiac Surgery System for the treatment of atrial fibrillation.
Adult subjects who are clinically indicated for a concomitant cardiac surgical
procedure will undergo left pulmonary vein, roof and floor ablations to form a
left atrial posterior box.
Following the surgical ablation procedure and hospital discharge, all study
subjects will be followed at 1 month, 6 months, and 12 months, and will be
exited from the study at the conclusion of the 12-month follow-up visit.
All subjects will return to the hospital between 60-120 days post-surgical
ablation procedure to undergo a cardiac electrophysiology study with
electroanatomical mapping to assess electrical isolation of the pulmonary veins
and left atrial posterior wall.
Intervention
- Left Pulmonary Vein Isolation -
Right atriotomy may be performed. The left veins are bluntly dissected and
encircled with umbilical tape. Pacing thresholds are obtained from the left
superior and left inferior PVs using a bipolar pacing probe. The left PVs are
then isolated using the CellFX nsPFA Cardiac Clamp creating as large a cuff of
atrial tissue as possible. PVI is documented by pacing at 20mA from both the
left superior and inferior PVs in order to confirm exit block. Additional
ablations are performed as needed until exit block is obtained.
- Roof and Floor Lesions -
Complete posterior LA isolation is achieved by completing a *box* lesion set.
From the inferior aspect of the left atriotomy, the CellFX nsPFA Cardiac Clamp
is used to create an ablation line across the floor of the left atrium towards
the orifice of left inferior PV. From the superior aspect of the left
atriotomy, the CellFX nsPFA Cardiac Clamp is used to create another ablation
line across the roof of the left atrium towards the left superior PV.
- Exit or Entrance Block Testing of the Posterior Wall-
At the conclusion of the procedure when the heart is off bypass, exit or
entrance block testing of the posterior wall should be completed.
Study burden and risks
There are no guaranteed benefits from participation in this study. The study
will provide an initial safety profile of the CellFX® nsPFA* Cardiac Surgery
System in treating this patient population.
The risk profile associated with the CellFX® nsPFA* Cardiac Surgery System, and
the ablation procedure is expected to be minimal and consistent with standard
surgical clamps that are always under the direct control of the surgeon.
When surgical AF ablation is an adjunctive procedure in a patient already
indicated for cardiac surgery, the additional risk of adding the ablation
procedure is quite minimal.
For detailed information on the risks of the devices used in the study
procedure, including a complete list of warnings, precautions, and potential
adverse events, please refer to the Instructions for Use (IFUs) for the Pulse
Biosciences CellFX nsPFA Cardiac Surgery System, and the Investigator Brochure.
The CellFX® nsPFA* Cardiac Surgery System is indicated to ablate cardiac tissue
during a concomitant procedure, such as, open coronary artery bypass grafting
and/or valvular replacement or repair.
Below is a list of potential adverse effects (e.g., complications) that are
associated with this combined procedure:
• Atelectasis
• Atrial perforation or rupture
• Cardiac Tamponade/Pericardial Effusion
• Cardiac valve injury
• Congestive Heart Failure
• Coronary Artery Spasm
• Damage to adjacent nerve and/or blood vessels
• Death
• Deep sternal wound infection, mediastinitis
• Diaphragmatic (phrenic nerve) paralysis
• Drug Reaction to General Anaesthesia
• Esophageal-left atrial fistula or esophageal rupture
• Excess Haptoglobin Levels (Hemolysis)
• Excessive bleeding that may require re-intervention
• Excessive pain and discomfort
• Extension of extracorporeal bypass time or aortic cross clamp time
• Infection resulting in sepsis or endocarditis
• Injury to unintended surrounding tissues, including tears and punctures
• Myocardial Infarction per ACC Guidelines
• Pericarditis (restrictive or constrictive)
• Perioperative atrial or ventricular rhythm/conduction disturbance
• Phrenic nerve damage
• Pneumonia
• Pneumothorax (persistent)-requiring intervention
• Pulmonary Vein Stenosis
• Stroke/Transient Ischemic Attack
• Thromboembolism
• Ventricular Arrhythmia (V. Tachycardia or V. Fibrillation)
• Ventricular perforation or rupture
Adverse effects specific to the ablation procedure includes arrhythmias,
coronary artery spasm, esophageal tissue damage, excess haptoglobin
levels (hemolysis), injury to the cardiac ablation treatment site, perforation
and phrenic nerve damage.
There may be other risks that are unknown at this time. Adverse events will be
collected and reviewed throughout the duration of the study and follow-up
period. The investigators will be notified of any additional risks identified
that could affect the health, safety, or welfare of the study subjects.
Point Eden Way Hayward 3957
Hayward 94545
US
Point Eden Way Hayward 3957
Hayward 94545
US
Listed location countries
Age
Inclusion criteria
1. Subject must be between 18 and 85 years of age
2. Subject is willing and capable of providing Informed Consent to undergo
study procedures which includes surgical AF ablation and completing follow-up
visits as specified in the clinical study protocol
3. Subject has history of documented atrial fibrillation within one year prior
to enrollment. Documentation may include ECG, transtelephonic monitor (TTM),
holter monitor or telemetry strip
4. Subject is scheduled to undergo non-emergent cardiac surgical procedure(s)
to be performed on cardiopulmonary bypass including open-heart surgery for one
or more of the following: Mitral valve repair or replacement, Aortic valve
repair or replacement, Ascending aortic aneurysms, or Coronary artery bypass
procedures
5. Left ventricular ejection fraction >= 30% (determined by echocardiography or
cardiac catheterization performed within 60 days of enrollment as documented in
patient medical history)
6. Subject has a life expectancy of at least 5 years
Exclusion criteria
1. Subject has an implantable electronic medical device. (i.e., pacemaker, ICD,
or CRT) or left atrial appendage device
2. Subject has a prosthetic heart valve
3. Stand- alone AF without indication(s) for concomitant Coronary Artery Bypass
Graft (CABG) and/or valve surgery
4. Previous surgical Maze procedure
5. Prior cardiac surgery (Redo)
6. Wolff-Parkinson-White syndrome or other Supra-Ventricular arrhythmia,
Atrioventricular (AV) nodal reentry
7. Subjects requiring surgery other than CABG and/or cardiac valve surgery
and/or atrial septal defect repair
8. Prior history of medical procedure involving instrumentation of the left
atrium (e.g., previous ablation)
9. Class IV New York Heart Association (NYHA) heart failure symptoms
10. Prior history of cerebrovascular accident or TIA within 6 months or at any
time if there is residual neurological deficit
11. Documented ST-segment elevation Myocardial Infarction (MI) within the 6
weeks prior to study enrollment
12. Need for emergent cardiac surgery (i.e., cardiogenic shock)
13. Known carotid artery stenosis greater than 80%
14. Current diagnosis of active systemic infection
15. Severe peripheral arterial occlusive disease defined as claudication with
minimal exertion
16. Renal failure requiring dialysis or hepatic failure
17. A known drug and/or alcohol addiction
18. Mental impairment or other conditions which may not allow the subject to
understand the nature, significance and scope of the study
19. Pregnancy or desire to get pregnant within 12-months of the study treatment
20. Preoperative need for an intra-aortic balloon pump or intravenous inotropes
21. Subjects who have been treated with thoracic radiation
22. Subjects in current chemotherapy
23. Subjects on long term treatment with oral or injected steroids (not
including intermittent use of inhaled steroids for respiratory diseases)
24. Subjects with known hypertrophic obstructive cardiomyopathy
25. Subjects with known cold agglutinin
26. History of abnormal bleeding and/or clotting disorder
27. Contraindication to anticoagulation (i.e., Heparin, Dabigatran, Apixaban,
Vitamin K Antagonists such as warfarin)
28. Solid organ or hematologic transplant, or currently being evaluated for an
organ transplant
29. Body mass index > 40 kg/m2
30. Use of any other investigational drug, therapy, or device within 30 days
prior to enrollment or concurrent participation in another research study
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 | NCT06355063 |
| CCMO | NL86709.000.24 |