Back to resultsThe PIFPAF-PFA Study (PIFPAF-PFA)
Primary Purpose
Persistent Atrial Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Pulmonary vein isolation without posterior wall ablation
Pulmonary vein isolation with posterior wall ablation
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring Pulmonary vein isolation, Pulsed field ablation, Left atrial posterior wall isolation
Eligibility Criteria
Inclusion Criteria: Persistent atrial fibrillation documented on a 12 lead ECG, Holter monitor or implantable cardiac device within last 2 years of enrollment Persistent atrial fibrillation is defined as a sustained episode lasting > 7 days Candidate for ablation based on current atrial fibrillation guidelines Continuous anticoagulation with Vitamin-K-Antagonists or a NOAC for ≥4 weeks prior to the ablation; or a transesophageal echocardiography and/or CT scan that excludes left atrial thrombus ≤48 hours before the ablation procedure Age of 18 years or older on the date of informed consent Signed informed consent Exclusion Criteria: Previous left atrial ablation or left atrial surgery Left atrial diameter >60 mm in the parasternal long axis Patients with paroxysmal atrial fibrillation Patients with persistent atrial fibrillation lasting >3 years AF due to reversible causes (e.g. hyperthyroidism, cardiothoracic surgery) Intracardiac thrombus Pre-existing pulmonary vein stenosis or pulmonary vein stent Pre-existing hemidiaphragmatic paralysis Contraindication to anticoagulation or radiocontrast materials Prior mitral valve surgery Severe mitral regurgitation or moderate/severe mitral stenosis Myocardial infarction during the 3-month period preceding the consent date Ongoing triple antithrombotic/anticoagulation therapy Cardiac surgery during the 3-month interval preceding the informed consent date or scheduled cardiac surgery/ transcatheter aortic valve implantation Significant congenital heart defect (including atrial septal defects or pulmonary vein abnormalities but not including a patent foramen ovale) NYHA class III or IV congestive heart failure Left ventricular ejection fraction (LVEF) <35% Hypertrophic cardiomyopathy (wall thickness >1.5 cm) Significant chronic kidney disease (eGFR <30 ml/min) Uncontrolled hyperthyroidism Cerebral ischemic event (stroke or TIA) during the 6-month interval preceding the informed consent date Ongoing systemic infections History of cryoglobulinemia Cardiac amyloidosis Pregnancy (to exclude pregnancy a blood test (HCG) is performed in women < 50 years before inclusion) Life expectancy less than one year per physician opinion Currently participating in any other clinical trial, which may confound the results of this trial Unwilling or unable to comply fully with the study procedures and follow-up
Sites / Locations
- Cantonal Hospital BadenRecruiting
- University Hospital BaselRecruiting
- Inselspital, University Hospital BernRecruiting
- University Hospital ZürichRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pulmonary vein isolation without posterior wall ablation
Pulmonary vein isolation with posterior wall ablation
Arm Description
Pulmonary vein isolation without left atrial posterior wall ablation
Pulmonary vein isolation with left atrial posterior wall ablation
Outcomes
Primary Outcome Measures
Time to first recurrence of any atrial tachyarrhythmia
Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between days 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)
Secondary Outcome Measures
Incidence of treatment-emergent adverse events: Cardiac tamponade
Number of patients with cardiac tamponade requiring drainage after PVI
Incidence of treatment-emergent adverse events: Persistent phrenic nerve palsy
Number of patients with persistent phrenic nerve palsy lasting >24 hours after PVI
Incidence of treatment-emergent adverse events: Serious vascular complication
Number of patients with serious vascular complications requiring intervention after PVI
Incidence of treatment-emergent adverse events: Stroke or TIA
Number of patients with stroke or TIA after PVI
Incidence of treatment-emergent adverse events: Atrioesophageal fistula
Number of patients with atrioesophageal fistula after PVI
Incidence of treatment-emergent adverse events: Death
Number of patients with fatal outcome/death after PVI
Total procedure time
Procedural endpoint
Total left atrial indwelling time
Procedural endpoint
Total fluoroscopy time
Procedural endpoint
Total radiation dose
Procedural endpoint
Change in hs-Troponin on day 1 post-ablation
Procedural endpoint
Pre-ablation 3D electro-anatomical mapping: Number of participants with scar as a region that demonstrated reproducibly an area of > 0.5×0.5 cm on the posterior wall with voltage less than 0.5 mV
Procedural endpoint
Post-ablation 3D electro-anatomical mapping: Proportion of isolated veins
Procedural endpoint
Post-ablation 3D electro-anatomical mapping: Proportion of isolated carinas
Procedural endpoint
Post-ablation 3D electro-anatomical mapping: Lesion size
Procedural endpoint
Post-ablation 3D electro-anatomical mapping: Posterior wall ablation success rate
Procedural endpoint
Time to first recurrence of any atrial tachyarrhythmia in patients with versus without left atrial posterior wall scar
Secondary endpoint during follow-up
Time to first recurrence of any atrial tachyarrhythmia in patients with left atrial posterior wall scar and posterior wall ablation versus without posterior wall ablation
Secondary endpoint during follow-up
Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between days 0-90 evaluated based on continuous ICM
Secondary endpoint during follow-up
Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between days 91-365 evaluated based on continuous ICM
Secondary endpoint during follow-up
Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between days 365 until explantation or end of life (EOL) of the ICM
Secondary endpoint during follow-up
Correlation of AF burden to symptoms and quality of life changes
Secondary endpoint during follow-up; Quality of life wil be measured with the EQ-5D-5L questionnaire where higher scores mean better outcomes; Symptoms will be measured with the AFEQT (Atrial Fibrillation Effect on Quality-of-life) questionnaire where higher scores mean worse outcomes
Reduction of percentage of time with cardiac arrhythmia (AF burden) by > 90% post ablation procedure
Secondary endpoint during follow-up
Comparison of the prevalence of the type of arrhythmia recurrence during follow-up being AF or organized atrial arrhythmias (AFL or AT)
Secondary endpoint during follow-up
Time to first recurrence of atrial tachyarrhythmia between days 91 and 365 evaluated based on continuous ICM in patients with presence of scar on the PW based on the preablation voltage map versus patients with no scar on the PW
Secondary endpoint during follow-up
Number of participants with persistent or paroxysmal AF during follow-up
Secondary endpoint during follow-up
Average heart rate as recorded by the ICM in months 1, 2 and 3 after ablation
Secondary endpoint during follow-up
Proportion of patients admitted to the hospital or emergency room because of documented recurrence of atrial arrhythmias
Secondary endpoint during follow-up
Proportion of patients undergoing a repeat ablation procedure because of documented recurrence of atrial arrhythmias
Secondary endpoint during follow-up
Number of participants reinitiating of antiarrhythmic drugs during follow-up
Secondary endpoint during follow-up
Number of participants with electrical cardioversion during follow-up
Secondary endpoint during follow-up
Number of reconnected pulmonary veins evaluated during redo procedures
Secondary endpoint during follow-up
Sites of reconnection (anterior, posterior, superior, inferior) of the pulmonary veins evaluated during redo procedures
Secondary endpoint during follow-up
Size of antral scar area (cm²) of the pulmonary veins evaluated during redo procedures
Secondary endpoint during follow-up
Number of reconnected posterior walls evaluated during redo procedures
Secondary endpoint during follow-up
Sites of reconnection of the posterior wall evaluated during redo procedures
Secondary endpoint during follow-up
Size of the scar area (cm²) of the posterior wall evaluated during redo procedures
Secondary endpoint during follow-up
Evolution of Quality of Life after 3 and 12 months
Secondary endpoint during follow-up; Quality of life wil be measured with the EQ-5D-5L questionnaire where higher scores mean better outcomes
Number of participants with stroke including TIA after 3, 12, 24 and 36 months
Secondary endpoint during follow-up
Number of participants with cardiovascular or non-cardiovascular death after 3, 12, 24 and 36 months
Secondary endpoint during follow-up
Full Information
NCT ID
NCT05986526
First Posted
July 25, 2023
Last Updated
August 2, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT05986526
Brief Title
The PIFPAF-PFA Study
Acronym
PIFPAF-PFA
Official Title
Pulmonary Vein Isolation With Pulsed-Field Ablation With Versus Without Posterior Wall Ablation in Patients With Symptomatic Persistent Atrial Fibrillation - A Multi-Center Randomized Clinical Trial: The PIFPAF-PFA Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
July 31, 2026 (Anticipated)
Study Completion Date
July 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Pulmonary vein isolation (PVI) is very effective for rhythm control in patients with paroxysmal atrial fibrillation (AF), but less successful in patients with persistent AF. Adding posterior wall ablation (PWA) to PVI is among the most promising ablation strategies to improve arrhythmiafree outcome in patients with persistent AF. Patients with left atrial posterior wall scar may benefit most from adding PWA to PVI. With previous ablation technology, posterior wall isolation (PWI) was difficult to achieve and increased the risk of procedural complications. With pulsed-field ablation (PFA), a technology is now available which is both very effective and safe for complete ablation of the posterior wall. The aim of this trial therefore is to compare the efficacy and procedural safety of two ablation strategies for the treatment of persistent AF using PFA: PVI only versus PVI with added PWA. The endpoint of atrial arrhythmia recurrence within 12 months will be assessed by an implantable cardiac monitor (ICM) with remote monitoring capabilities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
Pulmonary vein isolation, Pulsed field ablation, Left atrial posterior wall isolation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary vein isolation without posterior wall ablation
Arm Type
Active Comparator
Arm Description
Pulmonary vein isolation without left atrial posterior wall ablation
Arm Title
Pulmonary vein isolation with posterior wall ablation
Arm Type
Active Comparator
Arm Description
Pulmonary vein isolation with left atrial posterior wall ablation
Intervention Type
Procedure
Intervention Name(s)
Pulmonary vein isolation without posterior wall ablation
Intervention Description
Pulmonary vein isolation with Pulsed field ablation without left atrial posterior wall ablation. At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring
Intervention Type
Procedure
Intervention Name(s)
Pulmonary vein isolation with posterior wall ablation
Intervention Description
Pulmonary vein isolation with Pulsed field ablation with left atrial posterior wall ablation. At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring
Primary Outcome Measure Information:
Title
Time to first recurrence of any atrial tachyarrhythmia
Description
Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between days 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)
Time Frame
Days 91 to 365 post-ablation
Secondary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events: Cardiac tamponade
Description
Number of patients with cardiac tamponade requiring drainage after PVI
Time Frame
Days 0 to 30 post-ablation
Title
Incidence of treatment-emergent adverse events: Persistent phrenic nerve palsy
Description
Number of patients with persistent phrenic nerve palsy lasting >24 hours after PVI
Time Frame
Days 0 to 30 post-ablation
Title
Incidence of treatment-emergent adverse events: Serious vascular complication
Description
Number of patients with serious vascular complications requiring intervention after PVI
Time Frame
Days 0 to 30 post-ablation
Title
Incidence of treatment-emergent adverse events: Stroke or TIA
Description
Number of patients with stroke or TIA after PVI
Time Frame
Days 0 to 30 post-ablation
Title
Incidence of treatment-emergent adverse events: Atrioesophageal fistula
Description
Number of patients with atrioesophageal fistula after PVI
Time Frame
Days 0 to 30 post-ablation
Title
Incidence of treatment-emergent adverse events: Death
Description
Number of patients with fatal outcome/death after PVI
Time Frame
Days 0 to 30 post-ablation
Title
Total procedure time
Description
Procedural endpoint
Time Frame
Day 0, during procedure
Title
Total left atrial indwelling time
Description
Procedural endpoint
Time Frame
Day 0, during procedure
Title
Total fluoroscopy time
Description
Procedural endpoint
Time Frame
Day 0, during procedure
Title
Total radiation dose
Description
Procedural endpoint
Time Frame
Day 0, during procedure
Title
Change in hs-Troponin on day 1 post-ablation
Description
Procedural endpoint
Time Frame
Day 1 post-ablation
Title
Pre-ablation 3D electro-anatomical mapping: Number of participants with scar as a region that demonstrated reproducibly an area of > 0.5×0.5 cm on the posterior wall with voltage less than 0.5 mV
Description
Procedural endpoint
Time Frame
Day 0, shortly before ablation
Title
Post-ablation 3D electro-anatomical mapping: Proportion of isolated veins
Description
Procedural endpoint
Time Frame
Day 0, shortly after ablation
Title
Post-ablation 3D electro-anatomical mapping: Proportion of isolated carinas
Description
Procedural endpoint
Time Frame
Day 0, shortly after ablation
Title
Post-ablation 3D electro-anatomical mapping: Lesion size
Description
Procedural endpoint
Time Frame
Day 0, shortly after ablation
Title
Post-ablation 3D electro-anatomical mapping: Posterior wall ablation success rate
Description
Procedural endpoint
Time Frame
Day 0, shortly after ablation
Title
Time to first recurrence of any atrial tachyarrhythmia in patients with versus without left atrial posterior wall scar
Description
Secondary endpoint during follow-up
Time Frame
Day 0 to 36 months post-ablation
Title
Time to first recurrence of any atrial tachyarrhythmia in patients with left atrial posterior wall scar and posterior wall ablation versus without posterior wall ablation
Description
Secondary endpoint during follow-up
Time Frame
Day 0 to 36 months post-ablation
Title
Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between days 0-90 evaluated based on continuous ICM
Description
Secondary endpoint during follow-up
Time Frame
Day 0 to 90 post-ablation
Title
Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between days 91-365 evaluated based on continuous ICM
Description
Secondary endpoint during follow-up
Time Frame
Day 91 to 365 post-ablation
Title
Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between days 365 until explantation or end of life (EOL) of the ICM
Description
Secondary endpoint during follow-up
Time Frame
Day 365 post-ablation to explantation of ICM or end of life of ICM (up to 4 years after implantation of ICM)
Title
Correlation of AF burden to symptoms and quality of life changes
Description
Secondary endpoint during follow-up; Quality of life wil be measured with the EQ-5D-5L questionnaire where higher scores mean better outcomes; Symptoms will be measured with the AFEQT (Atrial Fibrillation Effect on Quality-of-life) questionnaire where higher scores mean worse outcomes
Time Frame
Day 0 and months 3 and 12 post-ablation
Title
Reduction of percentage of time with cardiac arrhythmia (AF burden) by > 90% post ablation procedure
Description
Secondary endpoint during follow-up
Time Frame
Day 0 to 36 months post-ablation
Title
Comparison of the prevalence of the type of arrhythmia recurrence during follow-up being AF or organized atrial arrhythmias (AFL or AT)
Description
Secondary endpoint during follow-up
Time Frame
Day 0 to 36 months post-ablation
Title
Time to first recurrence of atrial tachyarrhythmia between days 91 and 365 evaluated based on continuous ICM in patients with presence of scar on the PW based on the preablation voltage map versus patients with no scar on the PW
Description
Secondary endpoint during follow-up
Time Frame
Day 91 to 365 post-ablation
Title
Number of participants with persistent or paroxysmal AF during follow-up
Description
Secondary endpoint during follow-up
Time Frame
Day 0 to 36 months post-ablation
Title
Average heart rate as recorded by the ICM in months 1, 2 and 3 after ablation
Description
Secondary endpoint during follow-up
Time Frame
Months 1, 2 and 3 after ablation
Title
Proportion of patients admitted to the hospital or emergency room because of documented recurrence of atrial arrhythmias
Description
Secondary endpoint during follow-up
Time Frame
Day 0 to 36 months post-ablation
Title
Proportion of patients undergoing a repeat ablation procedure because of documented recurrence of atrial arrhythmias
Description
Secondary endpoint during follow-up
Time Frame
Day 0 to 36 months post-ablation
Title
Number of participants reinitiating of antiarrhythmic drugs during follow-up
Description
Secondary endpoint during follow-up
Time Frame
Day 0 to 36 months post-ablation
Title
Number of participants with electrical cardioversion during follow-up
Description
Secondary endpoint during follow-up
Time Frame
Day 0 to 36 months post-ablation
Title
Number of reconnected pulmonary veins evaluated during redo procedures
Description
Secondary endpoint during follow-up
Time Frame
During redo procedures between day 1 to 36 months post-ablation
Title
Sites of reconnection (anterior, posterior, superior, inferior) of the pulmonary veins evaluated during redo procedures
Description
Secondary endpoint during follow-up
Time Frame
During redo procedures between day 1 to 36 months post-ablation
Title
Size of antral scar area (cm²) of the pulmonary veins evaluated during redo procedures
Description
Secondary endpoint during follow-up
Time Frame
During redo procedures between day 1 to 36 months post-ablation
Title
Number of reconnected posterior walls evaluated during redo procedures
Description
Secondary endpoint during follow-up
Time Frame
During redo procedures between day 1 to 36 months post-ablation
Title
Sites of reconnection of the posterior wall evaluated during redo procedures
Description
Secondary endpoint during follow-up
Time Frame
During redo procedures between day 1 to 36 months post-ablation
Title
Size of the scar area (cm²) of the posterior wall evaluated during redo procedures
Description
Secondary endpoint during follow-up
Time Frame
During redo procedures between day 1 to 36 months post-ablation
Title
Evolution of Quality of Life after 3 and 12 months
Description
Secondary endpoint during follow-up; Quality of life wil be measured with the EQ-5D-5L questionnaire where higher scores mean better outcomes
Time Frame
Day 0 and months 3 and 12 post-ablation
Title
Number of participants with stroke including TIA after 3, 12, 24 and 36 months
Description
Secondary endpoint during follow-up
Time Frame
Months 3, 12, 24 and 36 post-ablation
Title
Number of participants with cardiovascular or non-cardiovascular death after 3, 12, 24 and 36 months
Description
Secondary endpoint during follow-up
Time Frame
Months 3, 12, 24 and 36 post-ablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Persistent atrial fibrillation documented on a 12 lead ECG, Holter monitor or implantable cardiac device within last 2 years of enrollment
Persistent atrial fibrillation is defined as a sustained episode lasting > 7 days
Candidate for ablation based on current atrial fibrillation guidelines
Continuous anticoagulation with Vitamin-K-Antagonists or a NOAC for ≥4 weeks prior to the ablation; or a transesophageal echocardiography and/or CT scan that excludes left atrial thrombus ≤48 hours before the ablation procedure
Age of 18 years or older on the date of informed consent
Signed informed consent
Exclusion Criteria:
Previous left atrial ablation or left atrial surgery
Left atrial diameter >60 mm in the parasternal long axis
Patients with paroxysmal atrial fibrillation
Patients with persistent atrial fibrillation lasting >3 years
AF due to reversible causes (e.g. hyperthyroidism, cardiothoracic surgery)
Intracardiac thrombus
Pre-existing pulmonary vein stenosis or pulmonary vein stent
Pre-existing hemidiaphragmatic paralysis
Contraindication to anticoagulation or radiocontrast materials
Prior mitral valve surgery
Severe mitral regurgitation or moderate/severe mitral stenosis
Myocardial infarction during the 3-month period preceding the consent date
Ongoing triple antithrombotic/anticoagulation therapy
Cardiac surgery during the 3-month interval preceding the informed consent date or scheduled cardiac surgery/ transcatheter aortic valve implantation
Significant congenital heart defect (including atrial septal defects or pulmonary vein abnormalities but not including a patent foramen ovale)
NYHA class III or IV congestive heart failure
Left ventricular ejection fraction (LVEF) <35%
Hypertrophic cardiomyopathy (wall thickness >1.5 cm)
Significant chronic kidney disease (eGFR <30 ml/min)
Uncontrolled hyperthyroidism
Cerebral ischemic event (stroke or TIA) during the 6-month interval preceding the informed consent date
Ongoing systemic infections
History of cryoglobulinemia
Cardiac amyloidosis
Pregnancy (to exclude pregnancy a blood test (HCG) is performed in women < 50 years before inclusion)
Life expectancy less than one year per physician opinion
Currently participating in any other clinical trial, which may confound the results of this trial
Unwilling or unable to comply fully with the study procedures and follow-up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent Roten, MD
Phone
+41 31 632 52 63
Email
Laurent.Roten@insel.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Roten, MD
Organizational Affiliation
Inselspital, University Hospital Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cantonal Hospital Baden
City
Baden
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Breitenstein, MD
Email
Alexander.Breitenstein@usz.ch
Facility Name
University Hospital Basel
City
Basel
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Badertscher, MD
Email
patrick.badertscher@usb.ch
Facility Name
Inselspital, University Hospital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Roten, MD
Phone
+41 31 632 52 63
Email
Laurent.Roten@insel.ch
Facility Name
University Hospital Zürich
City
Zürich
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ardan Saguner, MD
Email
Ardan.Saguner@usz.ch
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
The PIFPAF-PFA Study
We'll reach out to this number within 24 hrs