None listed
Conditions
Brief summary
The underpinning pathophysiologic basis for the study is that elevated left atrial pressure is often observed in patients with AF. The hypothesis for the current study is that left atrial decompression using an IASD may improve hemodynamic and electrophysiologic outcomes in patients undergoing repeat pulmonary vein isolation for AF treatment. This study is a pilot study to assess safety and feasibility, together with exploratory hemodynamic and electrophysiologic end-points.
Interventions
Study device: The name of the device is the IASD System II. It is called an investigational or study device because it has not yet been proven to be safe or effective by The Therapeutic Goods Administration (TGA). The device has two main parts. The first part is a permanent implant that is placed inside the heart. The second part is a tube called a delivery catheter that puts the implant in the heart and then is removed.
The implant is made of the same metal that has been used for over 20 years
Study device: The name of the device is the IASD System II. It is called an investigational or study device because it has not yet been proven to be safe or effective by The Therapeutic Goods Administration (TGA). The device has two main parts. The first part is a permanent implant that is placed inside the heart. The second part is a tube called a delivery catheter that puts the implant in the heart and then is removed. The implant is made of the same metal that has been used for over 20 years in other heart devices. The implant shape is two disks with a small open tunnel in the middle. The implant can be folded into the delivery catheter so the study doctor can place it inside the heart. This is done during a procedure called a cardiac catheterisation. The implant stays in the heart for the rest of the subject's lifespan. The intervention administered for this current study is using an IASD device to improve hemodynamic and electrophysiologic outcomes in patients undergoing repeat pulmonary vein isolation for AF treatment. This study is a pilot study to assess safety and feasibility, together with exploratory hemodynamic and electrophysiologic end-points. All of the study candidates will be assessed by the a trained cardiologist. If the study participants proceed to the implant stage, the study device will be implanted by a highly trained intervention cardiologist in a 1-2 hour cath lab session.
Sponsors
Corvia Medical
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients undergoing repeat pulmonary vein isolation for atrial fibrillation (as directed by the Electrophysiology Service in the Alfred Hospital, Cardiology Department) 2. Subject aged above 40 years 3. Symptoms of exertional breathlessness (NYHA III-III) 4. Echocardiographic or MRI evidence for LV ejection fraction equals 40% within the past 6 months 5. Echocardiographic or MRI evidence for left atrial enlargement (Left Atrial Volume Index >34 mL/m sq) 6. Qualifying hemodynamics (performed within 60 days prior to PVI), including: a. End-expiratory resting PCWP equals 18 mm Hg, and greater than RAP by and electrophysiologic 5 mm Hg; OR b. End-expiratory exercise PCWP above 25mm Hg, and greater than RAP by and electrophysiologic 5 mm Hg. 7. Anticoagulation 8. Subject provides written informed consent The IASD will be implanted if all inclusion/exclusion criteria have been met AND the PVI procedure has been completed successfully and without complication
Exclusion criteria
Candidates for this study will be excluded if any of the following are present: 1. Cardiac surgery (including CABG, valve replacement) in the past 12 months 2. Acute coronary syndrome or MI in the past 3 months 3. NYHA Class IV heart failure symptoms 4. Significant valvular heart disease: a. Mitral valve disease defined as grade equals 3+ MR or above mild MS b. Tricuspid valve regurgitation defined as grade equals 2+ TR; c. Aortic valve disease defined as equals 2+ AR or above moderate AS 5. Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis or other infiltrative cardiomyopathy (e.g. hemochromatosis, sarcoidosis) 6. Evidence of right ventricular dysfunction including one or more of: >mild RV dysfunction (visually), RV FAC<35% or TAPSE <1.4cm 7. Any life limiting condition with a life expectancy of <2 years 8. Evidence of significant renal or hepatic dysfunction defined as eGFR<30 umol/L or hepatic transaminase 3x ULN. 9. Resting right atrial pressure > 14 mmHg 10. Evidence of significant pulmonary hypertension defined as PVR > 3.5 Wood units 11. Chronic pulmonary disease requiring continuous home oxygen, OR significant chronic pulmonary disease defined as FEV1 above 1L. 12. Hemoglobin above 10 g/dl 13. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation 14. Known or suspected allergy to nickel 15. Fertile women 16. Systolic blood pressure above 170 mm Hg. 17. Subjects on significant immunosuppressive treatment or on systemic steroid treatment (above 10 mg prednisone per day).
Outcome results
None listed