Phase 4 N=67 Randomized Double-blind Treatment

Heart Rate Regularization in Patients With Permanent Atrial Fibrillation Post Marketing Study

Permanent Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT00246805 ↗

Enrolled (actual)

Serious AEs

3.0%

Results posted

Sep 2011

Primary outcome: Primary: Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE) — 32; 32; 15; 15 participants — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Vitatron pacemaker C20 SSIR or T20 SSIR models (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medtronic BRC
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE)	32; 32; 15; 15; 19; 19	<0.0001 sig
SECONDARY Evaluation of Rate Irregularity Indicators and Patient's Symptoms	—	—
SECONDARY Number of Patients That Should Undergo Atrioventricular Nodal (AVN) Ablation	—	—
SECONDARY Number of Patients That Should Undergo Drug Therapy in Combination With Pacing to Stabilize Heart Rate	—	—
SECONDARY Potential Discomforts of Pacing Algorithm for Heart Rate Stabilization	—	—

Summary

The purpose of this study is to monitor heart rate regularization in patients with permanent atrial fibrillation and standard indication for single chamber rate adaptive pacing VVI(R).

Eligibility Criteria

Inclusion Criteria

Patient has signed informed consent form
Patient with permanent atrial fibrillation, standard indication for VVI(R) pacing, and at least 1 episode of rate irregularity in the last month
New York Heart Association (NYHA) Class I, II, III
Patient is able to comply with follow-up times and will comply with the protocol
> 18 years of age

Exclusion Criteria

Paroxysmal atrial fibrillation
NYHA Class IV
Left ventricular ejection fraction (LVEF) < 35
Patients with unstable angina
Patients who have experienced an acute myocardial infarction or received coronary artery revascularization (CABG), or coronary angioplasty (PTCA) within 3 months prior to enrolment
Patient candidate for cardiac surgery, or coronary angioplasty (PTCA)
Patients who experienced a cardiovascular accident (CVA) or transient ischemic attack (TIA) with permanent disability
Life expectancy < 12 months due to other medical conditions
Pregnancy
The patient is enrolled in any concurrent (drug and/or device) study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00246805). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.