Rate Ventricular Control Therapy in Patients With Permane... | NCT01444573

Studies
Rate Ventricular Control Therapy in Patients With Permanent Atrial Fibrillation

NCT01444573

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Status

Unknown status

Last Update Posted

Sep 23, 2015Estimated

Enrollment

90Estimated

Phase

Phase 3

Conditions

Atrial Fibrillation

Interventions

implantable continuous monitor

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Dec 2012Actual

Completion Date

Sep 2015Estimated

First Submitted Date

Sep 29, 2011

First Submission Date that Met QC Criteria

Sep 29, 2011

First Posted Date

Sep 30, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2015

Last Update Posted Date

Sep 23, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 2 (Lenient control <120bpm)	Active Comparator		Device: implantable continuous monitor
Group 1 (Strict control <80 bpm)	Active Comparator		Device: implantable continuous monitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
implantable continuous monitor	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospitalization for all cardio-vascular events		12 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Evgeny A Pokushalov, MD, PhD	State Research Institute of Circulation Pathology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation	Recruiting	Novosibirsk		630055	Russia

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided