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

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.

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Key information

Conditions

Left Ventricular Dysfunction Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Università Politecnica delle Marche, Ancona, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rate Response on first (VVI biventricular pacing)

Device

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.

Rate Response off first (VVI biventricular pacing)

Device

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.

Primary outcomes

The distance covered during the 6-minute walking test

Time frame: 6 minutes

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Cardinale G. Panico

Other

Registry information

Official study title

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)

Acronym: RESPONSIBLE

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Feb 4, 2015
Registry last updated: Nov 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed