Rate RESPONSIVe Pacing in Patients With Permanent AF Underwent AV Node ABLation and bivEntricular Pacing (RESPONSIBLE)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect on distance covered in a 6 minute walking test of Rate Responsive pacing in patients with permanent atrial fibrillation and reduced left ventricular ejection fraction treated with atrioventricular junction ablation and biventricular pacing.

Detailed Description
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Patients with permanent atrial fibrillation and reduced left ventricular ejection fraction treated with atrioventricular junction ablation and biventricular pacing will be enrolled. Two 6' walking test (6WT), one during VVI 70/min biventricular pacing (RR off) and the other during VVIR 70-120/min biventricular pacing (RR on), will be performed one week apart; patients will be randomly and blindly assigned with a 1:1 ratio to group A (first 6WT RR off) or B (first 6WT RR on). The difference between the two tests will be recorded.

Official Title
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Effect on Exercise Capacity of Fixed Rate Vs Rate RESPONSIve Pacing in Patients With Permanent AF and Left Ventricular Dysfunction Underwent Radiofrequency Atrioventricular Junction aBLation and bivEntricular Pacing (RESPONSIBLE Study)

Conditions
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Left Ventricular Dysfunction, Atrial Fibrillation

Intervention / Treatment
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* Device: Rate Response on first (VVI biventricular pacing)
* Device: Rate Response off first (VVI biventricular pacing)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Permanent, refractory atrial fibrillation treated with atrio-ventricular node ablation and biventricular pacing Left ventricular systolic dysfunction Ability to perform a 6-minute walking test Completion of the 18th year of age Exclusion Criteria: Contraindications to 6 minute walking test IV NYHA Class

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RR on first<br>Rate Response on first | Device: Rate Response on first (VVI biventricular pacing)<br>* Rate Response function is turned on in the device. The patients performs a 6 minute walking test. After a week Rate Response function is turned off and the patient performs a second 6 minute walking test.<br>|
| Active Comparator: RR off first<br>Rate Response off first | Device: Rate Response off first (VVI biventricular pacing)<br>* Rate Response function is turned off in the device. The patients performs a 6 minute walking test. After a week Rate Response function is turned on and the patient performs a second 6 minute walking test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The distance covered during the 6-minute walking test |  | 6 minutes |