Rate Ventricular Control Therapy in Patients With Permanent Atrial Fibrillation

Rate Ventricular Control Therapy by Implantable Continuous Monitor in Patients With Permanent Atrial Fibrillation

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01444573

Acronym

REVEAL

Enrollment

Registered

2011-09-30

Start date

2011-09-30

Completion date

2015-09-30

Last updated

2015-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Rate control, ILR

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

Interventions

DEVICEimplantable continuous monitor

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
Hospitalization for all cardio-vascular events	12 months

Secondary

Measure	Time frame
All-cause death	12 months
stroke	12 months
life-threatening arrhythmic and drugs adverse events	12 months

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026