NCT00839566

Brief Summary

Examination of CRT efficacy in patients with progressive heart failure and atrial fibrillation at the same time

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_4 atrial-fibrillation

Timeline
Completed

Started Nov 2008

Typical duration for phase_4 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

Study Start

First participant enrolled

November 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 9, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 3, 2025

Status Verified

February 1, 2017

Enrollment Period

3.3 years

First QC Date

January 13, 2009

Last Update Submit

June 30, 2025

Conditions

Atrial FibrillationHeart Failure

Keywords

Atrial FibrillationHeart Failure

Outcome Measures

Primary Outcomes (1)

  • End systolic left ventricular diameter

    12 months

Secondary Outcomes (1)

  • NYHA-Class, Echo-parameters, ECG-parameters, VO2 max,6 minutes hallwalk-test

    12 months

Study Arms (3)

AV ablation

EXPERIMENTAL
Procedure: Ablation

Rate control

ACTIVE COMPARATOR

Rate control by drugs

Other: Rate Control

Sinus rhythm

NO INTERVENTION

Interventions

AblationPROCEDURE

AV-node ablation

AV ablation
Rate ControlOTHER

Rate control by drug

Rate control

Eligibility Criteria

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

You may qualify if:

  • LVEF \<35%
  • QRS time ≥150ms LBB
  • NYHA classification ≥ NYHA III
  • permanent (\> 6 months) Atrial Fibrillation
  • sinus rhythm (control group)
  • Condition after Implantation of a Medtronic CRT device
  • written informed consent

You may not qualify if:

  • exchange of the current CRT device
  • mitral incompetence (2. degree)
  • no compliance
  • participation in another study
  • pregnancy
  • patients with AV node
  • patients after heart transplant or those who are on the transplant list

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Professor Dr. med. Christian Perings

Lünen, 44534, Germany

Location

MeSH Terms

Conditions

Atrial FibrillationHeart Failure

Interventions

Heart Rate

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Christian Perings, MD

    marien Hospital Luenen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2009

First Posted

February 9, 2009

Study Start

November 1, 2008

Primary Completion

March 1, 2012

Study Completion

July 1, 2012

Last Updated

July 3, 2025

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Not applicable as NO is selected above for 'Plan to share IPD?"

Locations

DE(1)