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

Azienda Ospedaliera Cardinale G. Panico

Status: Completed

Conditions: Atrial Fibrillation; Left Ventricular Dysfunction

Treatments: Device: Rate Response off first (VVI biventricular pacing); Device: Rate Response on first (VVI biventricular pacing)

Study type: Interventional

Funder types: Other

Identifiers

NCT02354989

RESPONSIBLE

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 2 patient groups

RR on first

Active Comparator group

Description:

Rate Response on first

Treatment:

Device: Rate Response on first (VVI biventricular pacing)

RR off first

Active Comparator group

Description:

Rate Response off first

Treatment:

Device: Rate Response off first (VVI biventricular pacing)