Atrial Fibrillation, Heart Failure
Conditions
Keywords
Atrial Fibrillation, Heart Failure, AV Node ablation, Cardiac pacemaker, Antiarrhythmic drug
Brief summary
The purpose of this study is to determine whether early atrioventricular node (AVN) ablation with pacing device therapy will reduce death and hospitalization when compared to the conventional drug therapy in elderly patients with recurrent and symptomatic atrial fibrillation (AF).
Detailed description
Epidemiologic studies have shown that 70-80% of patients with atrial fibrillation are older than 65 years of age. Drug therapy for atrial fibrillation is not effective or not tolerated in many elderly patients, for both rate or rhythm strategies. Preliminary data from AVN ablation and pacemaker therapy demonstrated this strategy is highly effective in controlling symptoms among patients who have failed numerous drug therapy. Quality of life is improved while hospital admission and office visits are reduced. Pilot Study Design * All patients will be 1:1 randomized to standard-care drug therapy (American College of Cardiology/American Heart Association Guideline, 2006) or AV node ablation and pacemaker therapy * For patients randomized to AVN ablation, there will be a 1:1 sub-randomization to conventional right ventricular apex pacing or cardiac resynchronization therapy (biventricular pacing) * All patients will be followed at 2 and 6 months from the time of randomization in the pilot study. * A total of 60 patients from 5-15 clinical sites will be enrolled during an active recruiting period of 12 months for the pilot study.
Interventions
DRUGFDA approved rate and rhythm control drugs
Any approved rate or rhythm control drugs for treatment of atrial fibrillation may be prescribed under the primary physician's discretion. Rate Control: Beta-Blocker: * metoprolol * atenolol * carvedilol Calcium Channel Blocker: * verapamil * diltiazem Rhythm Control: * procainamide * quinidine * disopyramide * propafenone * flecainide * sotalol * dofetilide * amiodarone
DEVICEAV Node ablation and device implant
Pacing Systems: * Enpusle Premarket Approval Number (PMA#) P980035 * EnRhythm PMA# P980035 * Adapta PMA# P980035 Cardiac Resynchronization Therapy (CRT) Pacing Systems: \- InSync III/ Insync Maximo/InSyncII Marquis PMA# P010031 Implantable Cardioverter-Defibrillator (ICD) Pacing Systems: * EnTrust PMA# P980016 * Virtuoso PMA# P980016 ICD CRT Pacing Systems: * InSync Maximo PMA# P980016 * InSync Sentry PMA# P890003 * Concerto PMA# P980016
Sponsors
Medtronic
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than or equal to 65 years * Paroxysmal, persistent, or permanent atrial fibrillation * Index event of atrial fibrillation is documented on electrocardiogram or rhythm strip. Atrial fibrillation must be the qualifying event. Atrial flutter can have been present in the past, but it must not be considered the index arrhythmia. * Paroxysmal atrial fibrillation episodes must be recurrent (two or more episodes in the past 6 months). At least one of the paroxysmal episodes must be sustained, defined as lasting greater than 1 hour documented by a Holter monitor or by history in conjunction with an ECG or a rhythm strip. * At least one attempt of unsuccessful drug therapy, either for rate, for rhythm, or for rate-and-rhythm control. * Symptoms related to atrial fibrillation within the last 6 months * Eligible for long-term treatment with both treatment strategies * Must provide informed consent, Health Insurance Portability and Accountability Act (HIPAA) authorization, and be willing to comply with follow-up requirements.
Exclusion criteria
* Reversible causes of atrial fibrillation * On heart transplant list * Familial cardiac conditions with increased risk of sudden death * Asymptomatic * Medical condition limiting expected survival to be less than one year * Contraindications to anticoagulation * Pre-existing implanted pacemaker, implantable automatic cardioverter-defibrillator or cardiac resynchronization device. * Pre-existing indication for permanent pacemaker, implantable automatic cardioverter-defibrillator or cardiac resynchronization device * More than one attempt of drug therapy for rate, for rhythm, or for rate-and-rhythm control * Planned major surgery within the next six months, including thoracic surgery * Disability that would preclude collection of study data or have co-morbidity that would contraindicate device implantation * Participated in another clinical trial within the previous 30 days using a therapeutic modality which could have potential residual effects that might confound the results of this pilot study * Unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Hospitalization Within Six Months of Enrollment | Six months after enrollment | Number of patients who were hospitalized for cardiovascular problems within 6 months of enrollment. |
Countries
Canada, United States
Participant flow
Recruitment details
Subjects were recruited from 5 sites: (Mayo Clinic in Scottsdale, Arizona; Mayo Clinic in Rochester, Minnesota; Oregon Health and Science University in Portland, Oregon; University of Calgary in Calgary, Alberta, Canada; and The Heart Group in Evansville, Indiana.
Participants by arm
| Arm | Count |
|---|---|
| Drug Therapy FDA approved rate and rhythm control drugs | 14 |
| Atrioventricular Node (AVN) Ablation / Pacing Atrioventricular Node ablation and device implant | 13 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Drug Therapy | Atrioventricular Node (AVN) Ablation / Pacing | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 13 Participants | 27 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Canada | 2 participants | 2 participants | 4 participants |
| Region of Enrollment United States | 12 participants | 11 participants | 23 participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 14 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 14 | 5 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 |
Outcome results
Primary
Cardiac Hospitalization Within Six Months of Enrollment
Number of patients who were hospitalized for cardiovascular problems within 6 months of enrollment.
Time frame: Six months after enrollment
Population: Intent-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Drug Therapy | Cardiac Hospitalization Within Six Months of Enrollment | 3 participants |
| Atrioventricular Node (AVN) Ablation / Pacing | Cardiac Hospitalization Within Six Months of Enrollment | 4 participants |