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His-pacing and AV-node Ablation vs. Pulmonary Vein Isolation for Atrial Fibrillation (His-PAAF)

Primary Purpose

Atrial Fibrillation, Left Atrial Dilatation

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Conduction System pacing and AV node ablation
Atrial fibrillation ablation by pulmonary vein isolation
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Left atrial dilatation, Pulmonary vein isolation, AV node ablation, Conduction System pacing, Quality of Life, Age group 70 to 85 years

Eligibility Criteria

70 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Indication for invasive treatment of symptomatic atrial fibrillation according to current guidelines
  • LVEF >35%
  • Age 70-85 years
  • Persistent atrial fibrillation, or paroxysmal atrial fibrillation with at least moderate enlargement of the left atrium (≥42ml/m2)
  • Chronic and well-tolerated treatment with anticoagulants (either non-vitamin K oral anticoagulant or vitamin K antagonist)
  • Willingness to participate, to understand the instructions and fill out the questionnaires, and ability to sign informed consent

Exclusion Criteria:

  • Chronic atrial fibrillation with >1 year duration
  • BMI >40kg/m2
  • Hypertrophic cardiomyopathy
  • Severe heart failure with symptoms ≥ NYHA class IIIb
  • Heart amyloidosis
  • Cardiac sarcoidosis
  • Recent (<3 months) myocardial infarction
  • Significant heart valve disease (pronounced insufficiency or stenosis)
  • Pacemaker or ICD treatment ongoing, or current pacemaker indication
  • Congenital heart disease that required surgical correction
  • Comorbidity that is assessed significantly affect the patient's quality of life over the next year, or 3-year survival

Sites / Locations

  • Linköping University
  • Skane University Hospital
  • Stockholm Arrhythmia Center
  • Varberg HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Conduction System pacing plus AV node ablation

Pulmonary vein isolation

Arm Description

A His-pacing lead in combination with a backup RV pacing lead or an LBB pacing lead, and a right atrial lead (if needed) will be placed using standard technique. The His-pacing or LBB pacing lead will be Medtronic 3830, and the outer sheath will be either Medtronic C304 or C315 deflectable. If failure to implant with these tools, other leads and sheaths can be used at the discretion of the operator. A standard DDD pacemaker or CRT-P device from Medtronic will be used. A minimum of three weeks post-implant, the device will be interrogated and His-bundle threshold will be evaluated. A threshold of ≤2.0V@1.0ms is acceptable. If the device is well-functioning and successful His-pacing is documented, AV node ablation will be performed.

Atrial fibrillation will be performed as a complete pulmonary vein isolation. Either Cryoballon or radio frequency ablation with irrigated tip contact force enabled catheter can be used. Pulsed field ablation can be used if available. Endpoint is complete electrical isolation of all pulmonary veins, verified by entry- and exit block using a multipolar catheter during pacing.

Outcomes

Primary Outcome Measures

Health related Quality of Life: questionnaire
Improvement in the Physical Component Summary (PCS) of the SF-36 questionnaire

Secondary Outcome Measures

Safety endpoint: Proportion of patients with major adverse events
Proportion of patients with major adverse events that are devicerelated or related to ablation procedure (including but not limited to exit block, infection, perforation/tamponade, pericardial effusion, lead dislodgement, TIA/stroke, oesophago-atrial fistula, groin hematoma or vascular complication, pseudoaneurysm, phrenic nerve injury).
Mental Quality of Life: questionnaire
Improvement of the "mental" health related quality of life, measured by the mental component summary (MCS) of the SF-36 questionnaire
Arrhythmia related Quality of Life: ASTA questionnaire
Change in arrhythmia related quality of life as measured by the The Arrhythmia-Specific questionnaire in Tachycardia. The ASTA questionnaire consists of 13 items, each with a score of 0-4. A higher score denotes more symptoms associated with the arrhythmia. and Arrhythmia (ASTA) questionnaire
Anxiety and depression
Anxiety and depression symptoms, measured by the Hospital Anxiety and Depression Scale (HADS). The scale consists of 14 questions with 0 to 3 points for each, with a higher score denoting more depression/anxiety
Ejection fraction
Change in left ventricular systolic ejection fraction
Biomarker for heart failure
Change in NT-ProBNP level
Physical performance
Change in six minute walk test distance
Electrocardiography changes
Change in QRS duration on ECG
Health economy
Total atrial fibrillation and device related health care cost
Survival
Total survival and survival free of major complications
Hospitalization for heart failure
Risk of hospitalization for heart failure assessed by Kaplan Meier time dependent analysis using time from ablation to first hospitalization for heart failure within three years

Full Information

First Posted
July 1, 2020
Last Updated
February 16, 2023
Sponsor
Region Skane
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1. Study Identification

Unique Protocol Identification Number
NCT04512586
Brief Title
His-pacing and AV-node Ablation vs. Pulmonary Vein Isolation for Atrial Fibrillation
Acronym
His-PAAF
Official Title
Physiological Pacemaker Treatment in Combination With AV Node Ablation Compared With Pulmonary Vein Isolation for Patients With Symptomatic Atrial Fibrillation - a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Objective To investigate if conduction system pacing ((CSP) i.e. atrioventricular node ablation + His bundle pacing or Left Bundle Branch pacing) is as good as (or better than) atrial fibrillation ablation with pulmonary vein isolation for older patients (70-85yrs) with symptomatic atrial fibrillation and at least moderately dilated left atrium. Patient population: 90 patients aged 70-85 years with atrial fibrillation, referred to either AV node ablation or pulmonary vein isolation. Primary endpoint: Improvement in health-related quality of life as measured by the physical component summary (PCS) of the well-validated SF-36 form, at one year after AV node ablation + CSP or AF ablation. Secondary endpoints: Physical performance measured by 6-minute walk test, biochemical markers of heart failure (NT-ProBNP), frequency of complications, left ventricular systolic and diastolic function, and left atrial size evaluated after 12 months. Arrhythmia specific symptoms and anxiety will be measured with the ASTA and HADS questionnaires. Arrhythmia symptom correlation between subjective and objective findings. After three years, clinical endpoints will be evaluated regarding overall survival, and risk of heart failure hospitalization or death. The cost of the treatments will be compared, and estimated cost per quality adjusted year of life will be calculated, based on the EQ5D questionnaire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Left Atrial Dilatation
Keywords
Atrial fibrillation, Left atrial dilatation, Pulmonary vein isolation, AV node ablation, Conduction System pacing, Quality of Life, Age group 70 to 85 years

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients are randomized to either Conduction system pacing via His-pacing electrode, in combination with AV node ablation Pulmonary vein isolation ablation
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conduction System pacing plus AV node ablation
Arm Type
Experimental
Arm Description
A His-pacing lead in combination with a backup RV pacing lead or an LBB pacing lead, and a right atrial lead (if needed) will be placed using standard technique. The His-pacing or LBB pacing lead will be Medtronic 3830, and the outer sheath will be either Medtronic C304 or C315 deflectable. If failure to implant with these tools, other leads and sheaths can be used at the discretion of the operator. A standard DDD pacemaker or CRT-P device from Medtronic will be used. A minimum of three weeks post-implant, the device will be interrogated and His-bundle threshold will be evaluated. A threshold of ≤2.0V@1.0ms is acceptable. If the device is well-functioning and successful His-pacing is documented, AV node ablation will be performed.
Arm Title
Pulmonary vein isolation
Arm Type
Active Comparator
Arm Description
Atrial fibrillation will be performed as a complete pulmonary vein isolation. Either Cryoballon or radio frequency ablation with irrigated tip contact force enabled catheter can be used. Pulsed field ablation can be used if available. Endpoint is complete electrical isolation of all pulmonary veins, verified by entry- and exit block using a multipolar catheter during pacing.
Intervention Type
Procedure
Intervention Name(s)
Conduction System pacing and AV node ablation
Intervention Description
See study arm description.
Intervention Type
Procedure
Intervention Name(s)
Atrial fibrillation ablation by pulmonary vein isolation
Intervention Description
See study arm description
Primary Outcome Measure Information:
Title
Health related Quality of Life: questionnaire
Description
Improvement in the Physical Component Summary (PCS) of the SF-36 questionnaire
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Safety endpoint: Proportion of patients with major adverse events
Description
Proportion of patients with major adverse events that are devicerelated or related to ablation procedure (including but not limited to exit block, infection, perforation/tamponade, pericardial effusion, lead dislodgement, TIA/stroke, oesophago-atrial fistula, groin hematoma or vascular complication, pseudoaneurysm, phrenic nerve injury).
Time Frame
12 months
Title
Mental Quality of Life: questionnaire
Description
Improvement of the "mental" health related quality of life, measured by the mental component summary (MCS) of the SF-36 questionnaire
Time Frame
12 months
Title
Arrhythmia related Quality of Life: ASTA questionnaire
Description
Change in arrhythmia related quality of life as measured by the The Arrhythmia-Specific questionnaire in Tachycardia. The ASTA questionnaire consists of 13 items, each with a score of 0-4. A higher score denotes more symptoms associated with the arrhythmia. and Arrhythmia (ASTA) questionnaire
Time Frame
12 months
Title
Anxiety and depression
Description
Anxiety and depression symptoms, measured by the Hospital Anxiety and Depression Scale (HADS). The scale consists of 14 questions with 0 to 3 points for each, with a higher score denoting more depression/anxiety
Time Frame
12 months
Title
Ejection fraction
Description
Change in left ventricular systolic ejection fraction
Time Frame
12 months
Title
Biomarker for heart failure
Description
Change in NT-ProBNP level
Time Frame
12 months
Title
Physical performance
Description
Change in six minute walk test distance
Time Frame
12 months
Title
Electrocardiography changes
Description
Change in QRS duration on ECG
Time Frame
12 months
Title
Health economy
Description
Total atrial fibrillation and device related health care cost
Time Frame
12 months
Title
Survival
Description
Total survival and survival free of major complications
Time Frame
3 years
Title
Hospitalization for heart failure
Description
Risk of hospitalization for heart failure assessed by Kaplan Meier time dependent analysis using time from ablation to first hospitalization for heart failure within three years
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Indication for invasive treatment of symptomatic atrial fibrillation according to current guidelines LVEF >35% Age 70-85 years Persistent atrial fibrillation, or paroxysmal atrial fibrillation with at least moderate enlargement of the left atrium (≥42ml/m2) Chronic and well-tolerated treatment with anticoagulants (either non-vitamin K oral anticoagulant or vitamin K antagonist) Willingness to participate, to understand the instructions and fill out the questionnaires, and ability to sign informed consent Exclusion Criteria: Chronic atrial fibrillation with >1 year duration BMI >40kg/m2 Hypertrophic cardiomyopathy Severe heart failure with symptoms ≥ NYHA class IIIb Heart amyloidosis Cardiac sarcoidosis Recent (<3 months) myocardial infarction Significant heart valve disease (pronounced insufficiency or stenosis) Pacemaker or ICD treatment ongoing, or current pacemaker indication Congenital heart disease that required surgical correction Comorbidity that is assessed significantly affect the patient's quality of life over the next year, or 3-year survival
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rasmus Borgquist, MD PhD
Phone
+4646171010
Email
rasmus.borgquist@med.lu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Cecilia Rorsman, MD
Email
Cecilia.Rorsman@regionhalland.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rasmus Borgquist, MD PhD
Organizational Affiliation
Lund University, Skane University Hospital, Arrhythmia Section, Lund, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linköping University
City
Linköping
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulla Walfridsson, RN PhD
Email
Ulla.walfridsson@regionostergotland.se
Facility Name
Skane University Hospital
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Individual Site Status
Active, not recruiting
Facility Name
Stockholm Arrhythmia Center
City
Stockholm
Country
Sweden
Individual Site Status
Active, not recruiting
Facility Name
Varberg Hospital
City
Varberg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecilia Rorsman, MD
Email
cecilia.rorsman@med.lu.se

12. IPD Sharing Statement

Plan to Share IPD
No

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His-pacing and AV-node Ablation vs. Pulmonary Vein Isolation for Atrial Fibrillation

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