Rate Ventricular Control Therapy in Patients With Permanent Atrial Fibrillation
REVEAL
1 other identifier
interventional
90
1 country
1
Brief Summary
The investigators hypothesized that very lenient rate control is not inferior to strict or lenient rate control assessed by implantable continuous ECG monitor for preventing cardiovascular hospitalization and mortality in patients with long-standing persistent or permanent atrial fibrillation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 atrial-fibrillation
Started Sep 2011
Typical duration for phase_3 atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 29, 2011
CompletedFirst Posted
Study publicly available on registry
September 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedSeptember 23, 2015
September 1, 2015
1.3 years
September 29, 2011
September 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospitalization for all cardio-vascular events
12 months
Secondary Outcomes (3)
All-cause death
12 months
stroke
12 months
life-threatening arrhythmic and drugs adverse events
12 months
Study Arms (2)
Group 2 (Lenient control <120bpm)
ACTIVE COMPARATORGroup 1 (Strict control <80 bpm)
ACTIVE COMPARATORInterventions
The Reveal XT was implanted in the parasternal area of the chest. The requirement for defining the exact final position was an R-wave amplitude ≥0.4 mV assessed through the Vector Check.
Eligibility Criteria
You may qualify if:
- Long-standing persistent or permanent atrial fibrillation
- Mean resting heart rate \> 80 beats per minute with or without rate control medication
- Age \< 70 years old
- Constant use of anticoagulation therapy
You may not qualify if:
- Paroxysmal or persistent atrial fibrillation
- Non-stable heart failure or \> III NYHA FC
- Indications for IPG/CRT/ICD
- Thyroid dysfunction
- Inability to walk or bike.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
Novosibirsk, 630055, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evgeny A Pokushalov, MD, PhD
State Research Institute of Circulation Pathology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2011
First Posted
September 30, 2011
Study Start
September 1, 2011
Primary Completion
December 1, 2012
Study Completion
September 1, 2015
Last Updated
September 23, 2015
Record last verified: 2015-09