NCT02186314

Brief Summary

In this study we will select twenty patients with chronic atrial fibrillation and ventricular dysfunction with permanent cardiac pacemaker indication. We will dosage serum level natriuretic peptides for comparison between conventional and bifocal cardiac pacing.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2014

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

August 3, 2016

Status Verified

August 1, 2016

Enrollment Period

2.8 years

First QC Date

June 16, 2014

Last Update Submit

August 1, 2016

Conditions

Heart Failure

Keywords

atrial fibrillation, heart failure, pacemaker

Outcome Measures

Primary Outcomes (1)

  • Serum level of natriuretic peptides

    Assess whether resynchronization achieved by bifocal right ventricle pacing has influence on serum levels of natriuretic peptides and whether this could be used as a marker of success.

    2 months

Secondary Outcomes (3)

  • Clinical parameters

    2 months

  • Electrocardiographic parameters

    2 months

  • Assess quality of life

    2 months

Study Arms (2)

Apical stimulation

ACTIVE COMPARATOR

Pacemaker Biotronik: apical stimulation

Device: Pacemaker Biotronik: apical stimulationDevice: Pacemaker Biotronik: bifocal stimulation

Bifocal stimulation

ACTIVE COMPARATOR

Pacemaker Biotronik: bifocal stimulation

Device: Pacemaker Biotronik: apical stimulationDevice: Pacemaker Biotronik: bifocal stimulation

Interventions

Pacemaker Biotronik: apical stimulationDEVICE

Patients with pacemaker (Biotronik): an electrode will be implanted in the apical position of the right ventricle and an electrode implanted in the septal position of the right ventricle.The patients will remained in apical stimulation for two months, after that they will be subjected to evaluation. At the end of the evaluation, patients will undergo cross-over groups( bifocal stimulation) and patients will be kept in the new pacing mode for two months when they will be submitted to clinical, laboratory evaluation and assessment of pacemaker

Apical stimulationBifocal stimulation
Pacemaker Biotronik: bifocal stimulationDEVICE

Patients with pacemaker (Biotronik): an electrode will be implanted in the apical position of the right ventricle and an electrode implanted in the septal position of the right ventricle.The patients will remained in bifocal stimulation for two months, after that they will be subjected to evaluation. At the end of the evaluation, patients will undergo cross-over groups( apical stimulation) and patients will be kept in the new pacing mode for two months, when they will be submitted to clinical, laboratory evaluation and assessment of pacemaker

Apical stimulationBifocal stimulation

Eligibility Criteria

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

You may qualify if:

  • Permanent atrial fibrillation with bradycardia and classic indication for permanent pacemaker
  • mild or moderate ventricular dysfunction (35% \<left ventricle ejection fraction \<55%) of any etiology
  • Signature of the free and informed consent

You may not qualify if:

  • Age \<18 years
  • left ventricle ejection fraction \> 55% or ≤ 35%
  • classic indication of cardiac resynchronization therapy by Brazilian Guidelines for Cardiac Implantable Electronic Devices
  • Patients with left ventricle ejection fraction ≤ 35%, with permanent atrial fibrillation, heart failure with functional class III or IV despite optimal pharmacological treatment and QRS\> 150 ms
  • Patients with left ventricle ejection fraction ≤ 35%, with permanent atrial fibrillation, heart failure with functional class III or IV despite optimal pharmacological treatment and QRS 120-150 ms with evidence of dyssynchrony by imaging method
  • Patients with indication for pacemaker when ventricular pacing is essential, left ventricle ejection fraction ≤ 35% and heart failure with functional class III or IV
  • Refusal to signing the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carolina Christianini Mizzaci

São Paulo, São Paulo, 04012909, Brazil

RECRUITING

MeSH Terms

Conditions

Heart FailureAtrial Fibrillation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • carolina Mizzaci

    Instituto Dante Pazzanese de Cardiologia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolina Mizzaci

CONTACT

11 966209622carolina.mizzaci@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Effect of right bifocal cardiac ventricular pacing on serum level natriuretic peptides in patients with heart failure and pacemaker indication

Study Record Dates

First Submitted

June 16, 2014

First Posted

July 10, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2016

Study Completion

February 1, 2017

Last Updated

August 3, 2016

Record last verified: 2016-08

Locations

BR(1)