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AV Node Ablation and Pacemaker Therapy Compared to Drug Therapy for Atrial Fibrillation - Pilot Study (PACIFIC)

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ClinicalTrials.gov Identifier: NCT00589303
Recruitment Status : Terminated (Lack of funding)
First Posted : January 9, 2008
Results First Posted : April 4, 2013
Last Update Posted : April 4, 2013
Sponsor:
Collaborator:
Medtronic
Information provided by:
Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Atrial Fibrillation
Heart Failure
Interventions Drug: FDA approved rate and rhythm control drugs
Device: AV Node ablation and device implant
Enrollment 27
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.
Pre-assignment Details  
Arm/Group Title Drug Therapy Atrioventricular Node (AVN) Ablation / Pacing
Hide Arm/Group Description FDA approved rate and rhythm control drugs Atrioventricular Node ablation and device implant
Period Title: Overall Study
Started 14 13
Completed 12 12
Not Completed 2 1
Reason Not Completed
Withdrawal by Subject             2             1
Arm/Group Title Drug Therapy Atrioventricular Node (AVN) Ablation / Pacing Total
Hide Arm/Group Description FDA approved rate and rhythm control drugs Atrioventricular Node ablation and device implant Total of all reporting groups
Overall Number of Baseline Participants 14 13 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 27 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
14
 100.0%
13
 100.0%
27
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 27 participants
Female
8
  57.1%
6
  46.2%
14
  51.9%
Male
6
  42.9%
7
  53.8%
13
  48.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 27 participants
United States 12 11 23
Canada 2 2 4
1.Primary Outcome
Title Cardiac Hospitalization Within Six Months of Enrollment
Hide Description Number of patients who were hospitalized for cardiovascular problems within 6 months of enrollment.
Time Frame Six months after enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Drug Therapy Atrioventricular Node (AVN) Ablation / Pacing
Hide Arm/Group Description:
FDA approved rate and rhythm control drugs
Atrioventricular Node ablation and device implant
Overall Number of Participants Analyzed 14 13
Measure Type: Number
Unit of Measure: participants
3 4
Time Frame All subjects had a follow up at 2 and 6 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Drug Therapy Atrioventricular Node (AVN) Ablation / Pacing
Hide Arm/Group Description FDA approved rate and rhythm control drugs Atrioventricular Node ablation and device implant
All-Cause Mortality
Drug Therapy Atrioventricular Node (AVN) Ablation / Pacing
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Drug Therapy Atrioventricular Node (AVN) Ablation / Pacing
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/13 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Drug Therapy Atrioventricular Node (AVN) Ablation / Pacing
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/14 (7.14%)      5/13 (38.46%)    
Cardiac disorders     
Worsening Congestive Heart Failure   0/14 (0.00%)  0 1/13 (7.69%)  1
Lead Reposition  [1]  0/14 (0.00%)  0 1/13 (7.69%)  1
Volume Depletion  [2]  0/14 (0.00%)  0 1/13 (7.69%)  1
General disorders     
Fluid accumulation   1/14 (7.14%)  2 1/13 (7.69%)  1
Dizziness   0/14 (0.00%)  0 1/13 (7.69%)  1
Left upper extremity swelling   0/14 (0.00%)  0 1/13 (7.69%)  1
Infections and infestations     
Viral Pericarditis   0/14 (0.00%)  0 1/13 (7.69%)  1
Pneumonia   0/14 (0.00%)  0 1/13 (7.69%)  1
Musculoskeletal and connective tissue disorders     
Muscle Stimulation   0/14 (0.00%)  0 1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders     
Worsening Chronic Obstructive Pulmonary Disease (COPD)   0/14 (0.00%)  0 1/13 (7.69%)  1
Pneumothroax   0/14 (0.00%)  0 1/13 (7.69%)  1
Indicates events were collected by systematic assessment
[1]
The lead to the pacemaker had to be repositioned.
[2]
Volume depletion is the loss of both water and salts from cell volume.
The study was terminated when about half of the subjects were enrolled due to lack of funding.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Win K. Shen
Organization: Mayo Clinic
Phone: 480-342-0348
Publications:
Fuster V, Rydén LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Le Heuzey JY, Kay GN, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann S, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Halperin JL, Hunt SA, Nishimura R, Ornato JP, Page RL, Riegel B, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation. 2006 Aug 15;114(7):e257-354. Erratum in: Circulation. 2007 Aug 7;116(6):e138.
Responsible Party: Win K Shen MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00589303     History of Changes
Other Study ID Numbers: 06-004554
First Submitted: December 21, 2007
First Posted: January 9, 2008
Results First Submitted: February 25, 2013
Results First Posted: April 4, 2013
Last Update Posted: April 4, 2013