NCT02354989

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Azienda Ospedaliera Cardinale G. Panico · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Left Ventricular Dysfunction
• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Rate Response on first (VVI biventricular pacing)	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.
DEVICE	Rate Response off first (VVI biventricular pacing)	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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2015-02-04
• Last updated: 2015-11-30

Locations

7 sites across 1 country: Italy