Atrial FibrillationPhase 4NCT01233648
Resync-AF (Rate vs Rhythm Control in AF Patients With CRT-D)
A Phase 4 study of Atrial Fibrillation, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study is being done to find out if controlling rate or controlling rhythm is better for heart failure patients who also have AF. Patients with AF who are receiving a CRT-D device and AV node ablation as part of their clinical care will be followed for one year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Nov 2015
- Phase
- Phase 4
- 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
- Having persistent AF, defined as AF that does not self terminate for at least 24 consecutive hours.
- In AF upon entry into the operating room for CRT-D implantation and AV node ablation.
- Being on a stable dosage of an ACE inhibitor or ARB for at least 1 month preceding implant
- Being on a Beta-blocker for at least 3 months preceding implant and a stable dosage within 1 month of implant
- Not taking or able to be taken off all type I/III antiarrhythmic medications.
- Taking Coumadin so as to maintain an INR of between 2 and 3.
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- A Class I or IIa ICD indication
- NYHA Class III/IV within 1 month of baseline
- Intrinsic QRS duration ≥ 130 ms within 1 month prior to baseline
- Left ventricular ejection fraction ≤ 35% (method per physician discretion) within 1 month prior to baseline
- Left ventricular end diastolic dimension (LVEDD) ≥ 55 mm (method per physician discretion) within 1 months prior to baseline
- Willing to provide written informed consent
- Are expected to survive for 6 month of study participation
- Able to tolerate an urgent thoracotomy
- Able to tolerate < 1 mg dexamethasone sodium phosphate (steroid)
Who cannot join
- Having self-terminating or interminable AF
- Having unstable angina, or having experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within the past 1 month
- Post-heart transplant (patients on heart transplant list for the first time are not excluded)
- Having mechanical right heart valve
- Having an existing CRT or atrial therapy device(s)
- Being enrolled in any concurrent drug and/or device study which would confound the results of this trial
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- Having primary valvular disease and indicated for valve repair or replacement
- Having a previous AV node ablation
- Being on a Type I or Type III anti-arrhythmic medication for the treatment of ventricular tachyarrhythmias
- Women who are pregnant or with child bearing potential and who are not on a reliable form of birth control
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Cardiovascular Institute
Pittsburgh, Pennsylvania, 15213
About this study
This study is being done to find out if controlling rate or controlling rhythm is better for heart failure patients who also have AF. Patients with AF who are receiving a CRT-D device and AV node ablation as part of their clinical care will be followed for one year. One group will have their heart rate controlled by the ICD and AVN ablation alone and the second group will be treated with the ICD, AVN ablation and standard medical therapies to restore the heart's normal rhythm. The study doctors will compare the information collected from all of the subjects in this study to see if treating rate or treating rhythm is better in patients with heart failure and AF, resulting in a better quality of life.
- Conditions
- Atrial Fibrillation
- Being tested
- rate control via CRT-D and AVN ablation, rhythm control via pharmacologic, electrical or ablative therapies
- Keywords
- heart failure, CRT-D
- Medical subject headings
- Atrial Fibrillation, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rate control via CRT-D and AVN ablationOther
rate control
rhythm control via pharmacologic, electrical or ablative therapiesOther
rhythm control
| Study group | Role | What they receive |
|---|---|---|
| AF | Active comparator | Not described Receives: Other: rate control via CRT-D and AVN ablation |
| SR | Active comparator | Not described Receives: Other: rhythm control via pharmacologic, electrical or ablative therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF burden
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startJun 2006
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David S. Schwartzman, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233648
- Sponsor's protocol ID
- 0601113
- Status last verified
- Jan 2016
- First submitted
- 2 Nov 2010
- Last updated
- 23 Mar 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resync-AF (Rate vs Rhythm Control in AF Patients With CRT-D)
- ClinicalTrials.gov ID
- NCT01233648
- Acronym / sponsor ID
- 0601113
- Conditions
- Atrial Fibrillation
- Keywords
- heart failure, CRT-D
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 3 Nov 2010 (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.
This study is being done to find out if controlling rate or controlling rhythm is better for heart failure patients who also have AF. Patients with AF who are receiving a CRT-D device and AV node ablation as part of their clinical care will be followed for one year. One group will have their heart rate controlled by the ICD and AVN ablation alone and the second group will be treated with the ICD, AVN ablation and standard medical therapies to restore the heart's normal rhythm. The study doctors will compare the information collected from all of the subjects in this study to see if treating rate or treating rhythm is better in patients with heart failure and AF, resulting in a better quality of life.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AF | Active comparator | Other: rate control via CRT-D and AVN ablation |
| SR | Active comparator | Other: rhythm control via pharmacologic, electrical or ablative therapies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Having persistent AF, defined as AF that does not self terminate for at least 24 consecutive hours.
- In AF upon entry into the operating room for CRT-D implantation and AV node ablation.
- Being on a stable dosage of an ACE inhibitor or ARB for at least 1 month preceding implant
- Being on a Beta-blocker for at least 3 months preceding implant and a stable dosage within 1 month of implant
- Not taking or able to be taken off all type I/III antiarrhythmic medications.
Key exclusion criteria (10 listed)
- Having self-terminating or interminable AF
- Having unstable angina, or having experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within the past 1 month
- Post-heart transplant (patients on heart transplant list for the first time are not excluded)
- Having mechanical right heart valve
- Having an existing CRT or atrial therapy device(s)
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 control via CRT-D and AVN ablationrate control | Other | AF |
| rhythm control via pharmacologic, electrical or ablative therapiesrhythm control | Other | SR |
Primary outcome
AF burden
Time frame: 1 year
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 23 Mar 2023.
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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.
David S. Schwartzman, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Atrial Fibrillation, run by University of Pittsburgh at 1 site in United States.
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 15 inclusion and 10 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 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
AF burden (time frame: 1 year). 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 23 Mar 2023.