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

Primary Purpose

Left Ventricular Dysfunction, Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Rate Response on first (VVI biventricular pacing)
Rate Response off first (VVI biventricular pacing)
Sponsored by
Azienda Ospedaliera Cardinale G. Panico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Left Ventricular Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Azienda Ospedaliera "Card. G. Panico"
  • Università Politecnica delle Marche
  • Policlinico S.Orsola-Malpighi
  • AO Pugliese-Ciaccio
  • Seconda Università Napoli - A.O. Monaldi
  • AOU "Maggiore della Carità"
  • Ospedale San Filippo Neri

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

RR on first

RR off first

Arm Description

Rate Response on first

Rate Response off first

Outcomes

Primary Outcome Measures

The distance covered during the 6-minute walking test

Secondary Outcome Measures

Full Information

First Posted
January 30, 2015
Last Updated
November 26, 2015
Sponsor
Azienda Ospedaliera Cardinale G. Panico
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1. Study Identification

Unique Protocol Identification Number
NCT02354989
Brief Title
Rate RESPONSIVe Pacing in Patients With Permanent AF Underwent AV Node ABLation and bivEntricular Pacing (RESPONSIBLE)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda Ospedaliera Cardinale G. Panico

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Ventricular Dysfunction, Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RR on first
Arm Type
Active Comparator
Arm Description
Rate Response on first
Arm Title
RR off first
Arm Type
Active Comparator
Arm Description
Rate Response off first
Intervention Type
Device
Intervention Name(s)
Rate Response on first (VVI biventricular pacing)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Rate Response off first (VVI biventricular pacing)
Intervention Description
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 Outcome Measure Information:
Title
The distance covered during the 6-minute walking test
Time Frame
6 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pietro Palmisano, MD
Organizational Affiliation
Azienda Ospedaliera "Card. G. Panico" - Tricase
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliera "Card. G. Panico"
City
Tricase
State/Province
Lecce
ZIP/Postal Code
73039
Country
Italy
Facility Name
Università Politecnica delle Marche
City
Ancona
ZIP/Postal Code
60121
Country
Italy
Facility Name
Policlinico S.Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
AO Pugliese-Ciaccio
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Seconda Università Napoli - A.O. Monaldi
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
AOU "Maggiore della Carità"
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Ospedale San Filippo Neri
City
Roma
ZIP/Postal Code
00135
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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