Trial Outcomes & Findings for AV Node Ablation and Pacemaker Therapy Compared to Drug Therapy for Atrial Fibrillation - Pilot Study (NCT NCT00589303)

NCT ID: NCT00589303

Last Updated: 2013-04-04

Results Overview

Number of patients who were hospitalized for cardiovascular problems within 6 months of enrollment.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 27 participants
• Primary outcome timeframe: Six months after enrollment
• Results posted on: 2013-04-04

Participant Flow

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.

Participant milestones

Measure	Drug Therapy FDA approved rate and rhythm control drugs	Atrioventricular Node (AVN) Ablation / Pacing Atrioventricular Node ablation and device implant
Overall Study STARTED	14	13
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Drug Therapy FDA approved rate and rhythm control drugs	Atrioventricular Node (AVN) Ablation / Pacing Atrioventricular Node ablation and device implant
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Drug Therapy n=14 Participants FDA approved rate and rhythm control drugs	Atrioventricular Node (AVN) Ablation / Pacing n=13 Participants Atrioventricular Node ablation and device implant	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	11 participants n=7 Participants	23 participants n=5 Participants
Region of Enrollment Canada	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Six months after enrollment

Population: Intent-to-treat

Number of patients who were hospitalized for cardiovascular problems within 6 months of enrollment.

Outcome measures

Measure	Drug Therapy n=14 Participants FDA approved rate and rhythm control drugs	Atrioventricular Node (AVN) Ablation / Pacing n=13 Participants Atrioventricular Node ablation and device implant
Cardiac Hospitalization Within Six Months of Enrollment	3 participants	4 participants

Adverse Events

Drug Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Atrioventricular Node (AVN) Ablation / Pacing

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Drug Therapy n=14 participants at risk FDA approved rate and rhythm control drugs	Atrioventricular Node (AVN) Ablation / Pacing n=13 participants at risk Atrioventricular Node ablation and device implant
General disorders Fluid accumulation	7.1% 1/14 • Number of events 2 • All subjects had a follow up at 2 and 6 months.	7.7% 1/13 • Number of events 1 • All subjects had a follow up at 2 and 6 months.
Infections and infestations Viral Pericarditis	0.00% 0/14 • All subjects had a follow up at 2 and 6 months.	7.7% 1/13 • Number of events 1 • All subjects had a follow up at 2 and 6 months.
Infections and infestations Pneumonia	0.00% 0/14 • All subjects had a follow up at 2 and 6 months.	7.7% 1/13 • Number of events 1 • All subjects had a follow up at 2 and 6 months.
Musculoskeletal and connective tissue disorders Muscle Stimulation	0.00% 0/14 • All subjects had a follow up at 2 and 6 months.	7.7% 1/13 • Number of events 1 • All subjects had a follow up at 2 and 6 months.
Respiratory, thoracic and mediastinal disorders Worsening Chronic Obstructive Pulmonary Disease (COPD)	0.00% 0/14 • All subjects had a follow up at 2 and 6 months.	7.7% 1/13 • Number of events 1 • All subjects had a follow up at 2 and 6 months.
Cardiac disorders Worsening Congestive Heart Failure	0.00% 0/14 • All subjects had a follow up at 2 and 6 months.	7.7% 1/13 • Number of events 1 • All subjects had a follow up at 2 and 6 months.
Respiratory, thoracic and mediastinal disorders Pneumothroax	0.00% 0/14 • All subjects had a follow up at 2 and 6 months.	7.7% 1/13 • Number of events 1 • All subjects had a follow up at 2 and 6 months.
Cardiac disorders Lead Reposition	0.00% 0/14 • All subjects had a follow up at 2 and 6 months.	7.7% 1/13 • Number of events 1 • All subjects had a follow up at 2 and 6 months.
Cardiac disorders Volume Depletion	0.00% 0/14 • All subjects had a follow up at 2 and 6 months.	7.7% 1/13 • Number of events 1 • All subjects had a follow up at 2 and 6 months.
General disorders Dizziness	0.00% 0/14 • All subjects had a follow up at 2 and 6 months.	7.7% 1/13 • Number of events 1 • All subjects had a follow up at 2 and 6 months.
General disorders Left upper extremity swelling	0.00% 0/14 • All subjects had a follow up at 2 and 6 months.	7.7% 1/13 • Number of events 1 • All subjects had a follow up at 2 and 6 months.

Additional Information

Dr. Win K. Shen

Mayo Clinic

Phone: 480-342-0348

Email: wshen@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place