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

Atrial Fibrillation Clinical Trial

— RESPONSIBLE  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02354989
• Other study ID #: RESPONSIBLE
• Status: Completed
• Phase: N/A
• First received: January 30, 2015
• Last updated: November 26, 2015
• Start date: January 2015
• Est. completion date: February 2015

Study information

• Verified date: November 2015
• Source: Azienda Ospedaliera Cardinale G. Panico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Left Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Università Politecnica delle Marche	Ancona
Italy	Policlinico S.Orsola-Malpighi	Bologna
Italy	AO Pugliese-Ciaccio	Catanzaro
Italy	Seconda Università Napoli - A.O. Monaldi	Naples
Italy	AOU "Maggiore della Carità"	Novara
Italy	Ospedale San Filippo Neri	Roma
Italy	Azienda Ospedaliera "Card. G. Panico"	Tricase	Lecce

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Cardinale G. Panico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The distance covered during the 6-minute walking test		6 minutes	No