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Trial record 1 of 1 for:    NCT00589303
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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Drug Therapy FDA approved rate and rhythm control drugs
Atrioventricular Node (AVN) Ablation / Pacing Atrioventricular Node ablation and device implant

Participant Flow:   Overall Study
    Drug Therapy   Atrioventricular Node (AVN) Ablation / Pacing
STARTED   14   13 
COMPLETED   12   12 
NOT COMPLETED   2   1 
Withdrawal by Subject                2                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Drug Therapy FDA approved rate and rhythm control drugs
Atrioventricular Node (AVN) Ablation / Pacing Atrioventricular Node ablation and device implant
Total Total of all reporting groups

Baseline Measures
   Drug Therapy   Atrioventricular Node (AVN) Ablation / Pacing   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   13   27 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   0   0   0 
>=65 years   14   13   27 
Gender 
[Units: Participants]
     
Female   8   6   14 
Male   6   7   13 
Region of Enrollment 
[Units: Participants]
     
United States   12   11   23 
Canada   2   2   4 


  Outcome Measures

1.  Primary:   Cardiac Hospitalization Within Six Months of Enrollment   [ Time Frame: Six months after enrollment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was terminated when about half of the subjects were enrolled due to lack of funding.


  More Information

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
e-mail: wshen@mayo.edu


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