AV Node Ablation and Pacemaker Therapy Compared to Drug Therapy for Atrial Fibrillation - Pilot Study (PACIFIC)
This study has been completed.
Sponsor:
Mayo Clinic
Collaborator:
Medtronic
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00589303
First received: December 21, 2007
Last updated: January 17, 2012
Last verified: January 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation Heart Failure |
Drug: FDA approved rate and rhythm control drugs Device: AV Node ablation and device implant |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pacing and AV Node Ablation Compared to Drug Therapy in Symptomatic Elderly Patients With Atrial Fibrillation Clinical Trial (PACIFIC) - Pilot Study |
Resource links provided by NLM:
Genetics Home Reference related topics:
Brugada syndrome
familial atrial fibrillation
short QT syndrome
U.S. FDA Resources
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- all cause mortality [ Time Frame: six months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- health related quality of life measurements using validated instruments [ Time Frame: six months ] [ Designated as safety issue: No ]
- atrial fibrillation symptoms assessment using Symptom Check List and AF Severity Scale [ Time Frame: six months ] [ Designated as safety issue: No ]
- functional capacity by six minute walk [ Time Frame: six months ] [ Designated as safety issue: No ]
- all cause hospitalization [ Time Frame: six months ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | December 2007 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Pharmacologic therapy for rate or rhythm control
|
Drug: FDA approved rate and rhythm control drugs
Any approved rate or rhythm control drugs for treatment of atrial fibrillation may be prescribed under the primary physicians discretion. Rate Control: Beta-Blocker
Calcium Channel Blocked
Rhythm Control:
|
|
Active Comparator: B
AV Node ablation and pacemaker implantation
|
Device: AV Node ablation and device implant
Pacing Systems
CRT Pacing Systems • InSync III/ Insync Maximo/InSyncII Marquis PMA # P010031 ICD Pacing Systems
ICD CRT Pacing Systems
|
Detailed Description:
Epidemiologic studies have shown that70-80% 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 (ACC/AHA 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.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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, 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 tachycardia)
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00589303
Locations
| United States, Arizona | |
| Mayo Clinic Arizona | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, Indiana | |
| The Heart Group | |
| Evansville, Indiana, United States, 47710 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Oregon | |
| Oregon Health and Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, Tennessee | |
| Chattanooga Heart Institute | |
| Chattanooga, Tennessee, United States, 37404 | |
| Canada, Alberta | |
| University of Calgary and Calgary Health Region | |
| Calgary, Alberta, Canada, T2N-4N1 | |
Sponsors and Collaborators
Mayo Clinic
Medtronic
Investigators
| Principal Investigator: | Win K Shen, MD | Mayo Clinic |
More Information
Additional Information:
Publications:
| Responsible Party: | Win K Shen MD, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00589303 History of Changes |
| Other Study ID Numbers: | 06-004554 |
| Study First Received: | December 21, 2007 |
| Last Updated: | January 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Mayo Clinic:
|
Atrial Fibrillation Heart Failure AV Node ablation Cardiac pacemaker Antiarrhythmic drug |
Additional relevant MeSH terms:
|
Atrial Fibrillation Heart Failure Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases |
Pathologic Processes Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 17, 2012
