Left Ventricular DysfunctionRESPONSIBLENCT02354989
Rate RESPONSIVe Pacing in Patients With Permanent AF Underwent AV Node ABLation and bivEntricular Pacing (RESPONSIBLE)
A study testing Rate Response on first (VVI biventricular pacing) and Rate Response off first (VVI biventricular pacing) in people with Left Ventricular Dysfunction and Atrial Fibrillation, run by Azienda Ospedaliera Cardinale G. Panico at 7 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Dysfunction, Atrial Fibrillation
- What is being tested?
- Rate Response on first (VVI biventricular pacing) and Rate Response off first (VVI biventricular pacing)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesItaly
- Study dates
- Jan 2015to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindications to 6 minute walking test
- IV NYHA Class
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
Università Politecnica delle Marche
Ancona, Ancona, 60121
Policlinico S.Orsola-Malpighi
Bologna, Bologna, 40138
AO Pugliese-Ciaccio
Catanzaro, Catanzaro, 88100
Seconda Università Napoli - A.O. Monaldi
Naples, Naples, 80131
AOU "Maggiore della Carità"
Novara, Novara, 28100
Ospedale San Filippo Neri
Roma, Roma, 00135
Azienda Ospedaliera "Card. G. Panico"
Tricase, Lecce, 73039
About this study
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)
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.
Read the 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.
- Conditions
- Left Ventricular Dysfunction, Atrial Fibrillation
- Being tested
- Rate Response on first (VVI biventricular pacing), Rate Response off first (VVI biventricular pacing)
- Medical subject headings
- Ventricular Dysfunction, Left, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| RR on first | Active comparator | Rate Response on first Receives: Device: Rate Response on first (VVI biventricular pacing) |
| RR off first | Active comparator | Rate Response off first Receives: Device: Rate Response off first (VVI biventricular pacing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The distance covered during the 6-minute walking test
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Cardinale G. Panico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pietro Palmisano, MD, Principal investigator, Azienda Ospedaliera "Card. G. Panico" - Tricase
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354989
- Sponsor's protocol ID
- RESPONSIBLE
- Acronym
- RESPONSIBLE
- Status last verified
- Nov 2015
- First submitted
- 30 Jan 2015
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02354989
- Acronym / sponsor ID
- RESPONSIBLE / RESPONSIBLE
- Conditions
- Left Ventricular Dysfunction, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Cardinale G. PanicoUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 4 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RR on first | Active comparator | Device: Rate Response on first (VVI biventricular pacing)Rate Response on first |
| RR off first | Active comparator | Device: Rate Response off first (VVI biventricular pacing)Rate Response off first |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Contraindications to 6 minute walking test
- IV NYHA Class
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | RR on first |
| 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. | Device | RR off first |
Primary outcome
The distance covered during the 6-minute walking test
Time frame: 6 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pietro Palmisano, MD principal investigator
Azienda Ospedaliera "Card. G. Panico" - Tricase
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rate Response on first (VVI biventricular pacing) and Rate Response off first (VVI biventricular pacing) in people with Left Ventricular Dysfunction and Atrial Fibrillation, run by Azienda Ospedaliera Cardinale G. Panico at 7 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The distance covered during the 6-minute walking test (time frame: 6 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2015.