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

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Left Ventricular Dysfunction
• Interventions: Device: Rate Response off first (VVI biventricular pacing); Device: Rate Response on first (VVI biventricular pacing)

• Registration Number: NCT02354989
• Lead Sponsor: Azienda Ospedaliera Cardinale G. Panico

Brief 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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-30
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Study First Submitted QC: 2015-02-03
• Study First Posted: 2015-02-04
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-26
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
RR off first	Rate Response off first (VVI biventricular pacing)	Rate Response off first
RR on first	Rate Response on first (VVI biventricular pacing)	Rate Response on first

Primary Outcome Measures

Name	Time	Method
The distance covered during the 6-minute walking test	6 minutes

Trial Locations

Locations (7)

Azienda Ospedaliera "Card. G. Panico"; 🇮🇹 Tricase, Lecce, Italy

Università Politecnica delle Marche; 🇮🇹 Ancona, Italy

Policlinico S.Orsola-Malpighi; 🇮🇹 Bologna, Italy

AO Pugliese-Ciaccio; 🇮🇹 Catanzaro, Italy

Ospedale San Filippo Neri; 🇮🇹 Roma, Italy

Seconda Università Napoli - A.O. Monaldi; 🇮🇹 Naples, Italy

AOU "Maggiore della Carità"; 🇮🇹 Novara, Italy