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

November 26, 2015 updated by: Azienda Ospedaliera Cardinale G. Panico

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy, 60121
        • Università Politecnica delle Marche
      • Bologna, Italy, 40138
        • Policlinico S.Orsola-Malpighi
      • Catanzaro, Italy, 88100
        • AO Pugliese-Ciaccio
      • Naples, Italy, 80131
        • Seconda Università Napoli - A.O. Monaldi
      • Novara, Italy, 28100
        • AOU "Maggiore della Carità"
      • Roma, Italy, 00135
        • Ospedale San Filippo Neri
    • Lecce
      • Tricase, Lecce, Italy, 73039
        • Azienda Ospedaliera "Card. G. Panico"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: RR on first
Rate Response on first
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.
Active Comparator: RR off first
Rate Response off first
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The distance covered during the 6-minute walking test
Time Frame: 6 minutes
6 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Cardinale G. Panico

Investigators

  • Principal Investigator: Pietro Palmisano, MD, Azienda Ospedaliera "Card. G. Panico" - Tricase

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

January 30, 2015

First Submitted That Met QC Criteria

February 3, 2015

First Posted (Estimate)

February 4, 2015

Study Record Updates

Last Update Posted (Estimate)

November 30, 2015

Last Update Submitted That Met QC Criteria

November 26, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESPONSIBLE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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