Atrial FibrillationAVERT-AFNCT00547794
AVJ Ablation Followed by Resynchronization Therapy in Patients With CHF and AF
An observational study of Atrial Fibrillation and Congestive Heart Failure, run by Abbott Medical Devices at 1 site in United States.
Trial summary
The purpose of the study is to determine if the combination of AVJ ablation followed by BiV pacing significantly improves functional status and exercise capacity compared to pharmacologic rate control in patients with chronic AF and depressed ejection fraction, regardless of rate or QRS duration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Congestive Heart Failure
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Nov 2010
- Phase
- Observational
- 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
Study population: Patient with history of permanent AF and CHF
Who may be able to join
- Symptomatic permanent AF
- Class I or II indication for ICD
- LVEF ≤ 35% within 6 months
- NYHA class II or III with a history of CHF
- Maximal tolerated drug therapy for CHF and rate control with a stable regimen for ≥ 30 days
- Ability to independently comprehend and complete a QoL questionnaire
- Ability to give informed consent for study participation and willingness and ability to comply with prescribed follow-up tests and scheduled evaluations
Who cannot join
- Paroxysmal or persistent AF
- Class I indication for pacing (including AVJ ablation for poor rate control)
- Ability to walk ≥ 450 meters in 6 minutes
- Musculoskeletal disorders that prohibit the completion of a 450 meters walk
- NYHA class I or IV at the time of enrollment
- A contraindication to taking Coumadin therapy
Show all 16Show fewer
- History of myocardial infarction, percutanous coronary intervention, or CABG in the past 30 days
- History of mitral valve surgery
- Prior attempts for cardiac resynchronization therapy
- The presence of an existing coronary sinus lead or epicardial lead
- Life expectancy < 1year
- Age < 18 yrs
- Current participation in other clinical studies except registry trials
- Use of calcium channel blockers
- Pregnancy
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AVERT-AF: Atrio-VEntricular Junction Ablation Followed by Resynchronization Therapy in Patients With Congestive Heart Failure and Atrial Fibrillation
The purpose of the study is to determine if the combination of AVJ ablation followed by BiV pacing significantly improves functional status and exercise capacity compared to pharmacologic rate control in patients with chronic AF and depressed ejection fraction, regardless of rate or QRS duration.
Read the detailed description
- This is a prospective, randomized, double blinded, multicenter study
- Patients meeting all the enrollment criteria are screened at enrollment and randomized to Group 1 (Pharmacological therapy + Single Chamber ICD) or Group 2 (AVJ Ablation + CRT-D)
- Screened patients are implanted with a FDA approved SJM ICD/CRT-D with compatible lead system
- Patients are followed at 1, 3, 6 and 12 months post implant
- Total # of centers - 20 centers
- Sample size - 180 patients
- Conditions
- Atrial Fibrillation, Congestive Heart Failure
- 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.
| Study group | Role | What they receive |
|---|---|---|
| CRT-D + AVJ Ablation | Not described | |
| Single-Chamber ICD + Pharmacological Therapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise duration
Measured: 12 month post implant
Secondary outcomes (3)
Quality of Life (QOL) via Minnesota Living With Heart Failure (MLWH) questionnaire
Measured: 12 month post implant
NYHA Class Progression
Measured: 12 month post implant
LVEF
Measured: 12 month post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2007 (estimated)
- Study startJun 2007
- Primary completionAug 2010
- Study completionNov 2010
Why it stopped: Difficulty in patient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohamed Hamdan, MD, Principal investigator, University of Utah Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547794
- Sponsor's protocol ID
- CRD 310
- Acronym
- AVERT-AF
- Status last verified
- Feb 2019
- First submitted
- 19 Oct 2007
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hamdan MH, Freedman RA, Gilbert EM, Dimarco JP, Ellenbogen KA, Page RL. Atrioventricular junction ablation followed by resynchronization therapy in patients with congestive heart failure and atrial fibrillation (AVERT-AF) study design. Pacing Clin Electrophysiol. 2006 Oct;29(10):1081-8. doi: 10.1111/j.1540-8159.2006.00502.x.
PubMed 17038140
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AVERT-AF: Atrio-VEntricular Junction Ablation Followed by Resynchronization Therapy in Patients With Congestive Heart Failure and Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00547794
- Acronym / sponsor ID
- AVERT-AF / CRD 310
- Conditions
- Atrial Fibrillation, Congestive Heart Failure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty in patient enrollment
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 23 Oct 2007 (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 the study is to determine if the combination of AVJ ablation followed by BiV pacing significantly improves functional status and exercise capacity compared to pharmacologic rate control in patients with chronic AF and depressed ejection fraction, regardless of rate or QRS duration.
Detailed description
- This is a prospective, randomized, double blinded, multicenter study
- Patients meeting all the enrollment criteria are screened at enrollment and randomized to Group 1 (Pharmacological therapy + Single Chamber ICD) or Group 2 (AVJ Ablation + CRT-D)
- Screened patients are implanted with a FDA approved SJM ICD/CRT-D with compatible lead system
- Patients are followed at 1, 3, 6 and 12 months post implant
- Total # of centers - 20 centers
- Sample size - 180 patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT-D + AVJ Ablation | – | – |
| Single-Chamber ICD + Pharmacological Therapy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with history of permanent AF and CHF
Key inclusion criteria (7 listed)
- Symptomatic permanent AF
- Class I or II indication for ICD
- LVEF ≤ 35% within 6 months
- NYHA class II or III with a history of CHF
- Maximal tolerated drug therapy for CHF and rate control with a stable regimen for ≥ 30 days
Key exclusion criteria (16 listed)
- Paroxysmal or persistent AF
- Class I indication for pacing (including AVJ ablation for poor rate control)
- Ability to walk ≥ 450 meters in 6 minutes
- Musculoskeletal disorders that prohibit the completion of a 450 meters walk
- NYHA class I or IV at the time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Exercise duration
Time frame: 12 month post implant
3 secondary outcomes
Quality of Life (QOL) via Minnesota Living With Heart Failure (MLWH) questionnaire
Time frame: 12 month post implant
NYHA Class Progression
Time frame: 12 month post implant
LVEF
Time frame: 12 month post implant
Results and safety
The study was stopped early (reason given: Difficulty in patient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Background: PubMed 17038140Hamdan MH, Freedman RA, Gilbert EM, Dimarco JP, Ellenbogen KA, Page RL. Atrioventricular junction ablation followed by resynchronization therapy in patients with congestive heart failure and atrial fibrillation (AVERT-AF) study design. Pacing Clin Electrophysiol. 2006 Oct;29(10):1081-8. doi: 10.1111/j.1540-8159.2006.00502.x.
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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.
Mohamed Hamdan, MD principal investigator
University of Utah Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Congestive Heart Failure, run by Abbott Medical Devices 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 7 inclusion and 16 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: stopped early, as of the sponsor's last update on 4 Feb 2019. 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.
Are results available for this study?
The study was stopped early (reason given: Difficulty in patient enrollment). Results are not available in the source record.
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?
Exercise duration (time frame: 12 month post implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00547794, which also lists 1 linked publication.
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 4 Feb 2019.