NCT01181414

Brief Summary

The aim of the present study is to compare the response to cardiac resynchronization therapy (CRT) in patients with chronic advanced heart failure and permanent atrial fibrillation (AF) depending on atrio ventricular junction (AVJ) is ablated or not.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2010

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 13, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

4.1 years

First QC Date

August 2, 2010

Last Update Submit

March 9, 2015

Conditions

Chronic Heart FailureCardiomyopathy, DilatedAtrial Fibrillation

Keywords

Permanent Atrial FibrillationResynchronization therapyAblation

Outcome Measures

Primary Outcomes (1)

  • Left ventricular reverse remodelling in cardiac resynchronization therapy and atrial fibrillation.

    Comparison of echocardiographic responders in patients with permanent atrial fibrillation submitted to cardiac resynchronization therapy depending on whether the atrio-ventricular junction is ablated or not. Echocardiographic response was defined as left ventricular end-systolic volume reduction \>10%.

    1-year follow-up

Secondary Outcomes (1)

  • Clinical response to Cardiac resynchronization therapy.

    1-year follow-up

Study Arms (2)

Atrioventricular junction ablation

EXPERIMENTAL

Atrioventricular junction ablation by using radiofrequency energy.

Procedure: Atrio ventricular junction ablation with radio-frequency

Drug control of ventricular rate

ACTIVE COMPARATOR

Drug control of ventricular rate.

Drug: Beta blocker/digoxine/amiodarone

Interventions

Atrio ventricular junction ablation with radio-frequencyPROCEDURE

Atrioventricular junction ablation by using radiofrequency energy.

Atrioventricular junction ablation
Beta blocker/digoxine/amiodaroneDRUG

Ventricular rate control by using drug treatment.

Also known as: Negative chronotropic drugs pharmacological treatment .
Drug control of ventricular rate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dilated cardiomyopathy (LVEDD \>56 mm)
  • wide QRS (\> 120 msec)
  • NYHA III-IV
  • EF\<35%
  • Permanent AF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Cardiomyopathy, DilatedAtrial Fibrillation

Interventions

Adrenergic beta-Antagonists

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adrenergic AntagonistsAdrenergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of Drugs

Study Officials

  • Jose M Tolosana, M.D.

    Hospital Clinic, University of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Arrhythmia Unit

Study Record Dates

First Submitted

August 2, 2010

First Posted

August 13, 2010

Study Start

October 1, 2010

Primary Completion

November 1, 2014

Study Completion

January 1, 2015

Last Updated

March 10, 2015

Record last verified: 2015-03

Locations

ES(1)