NCT00528307

Brief Summary

To determine whether Biventricular pacing in patients undergoing HIS bundle ablation for atrial fibrilation has beneficial effects on myocardial perfusion and left ventricularr ejection fraction.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Oct 2007

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
terminated

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

September 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2007

Completed
19 days until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

2.8 years

First QC Date

September 11, 2007

Last Update Submit

November 4, 2014

Conditions

Atrial Fibrillation

Keywords

myocardial perfusionHis ablationbiventricular pacingHis bundle ablation for atrial fibrillation

Outcome Measures

Primary Outcomes (1)

  • Difference in size of myocardial perfusion abnormalities in the two treatment groups as measured with MPS.

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR

First 3 months of biventricular pacing, second 3 months right ventricular apical pacing

Device: HIS buldle ablation

2

ACTIVE COMPARATOR

First 3 months of right ventricular apical pacing, second 3 months biventricular pacing

Device: HIS buldle ablation

Interventions

HIS buldle ablationDEVICE

HIS bundle ablation, followed by implant of a biventricular pacemaker

12

Eligibility Criteria

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

You may qualify if:

  • Normal to nearly normal LVF (EF \> 40%)
  • Drug-refractory, persistent or permanent atrial fibrillation
  • Referred for His ablation

You may not qualify if:

  • Unwilling or unable to sign the informed consent
  • Life expectancy \< 1year from non-cardiac causes
  • Previous myocardial infarction
  • Previous coronary bypass surgery
  • Poor left ventricle function (EF\< 40%) from any cause
  • Symptomatic obstructive coronary artery disease
  • Poor ultra sound imaging quality.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Antonius Hospital

Nieuwegein, Utrecht, 3435CM, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lucas VA Boersma, MD, PHD

    St. Antonius Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 11, 2007

First Posted

September 12, 2007

Study Start

October 1, 2007

Primary Completion

July 1, 2010

Study Completion

December 1, 2010

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations

NL(1)