NCT04662970

Brief Summary

The principal aim is to analyze total left and right ventricular activation time in different CRT device programming algorithms (SyncAV) measured by non-invasive electrophysiology

Trial Health

77
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
20mo left

Started Jan 2020

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress79%
Jan 2020Dec 2027

Study Start

First participant enrolled

January 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 10, 2020

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

8 years

First QC Date

November 30, 2020

Last Update Submit

September 29, 2025

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Optimal (shortest) activation time of the right and left ventricular in heart failure patients after CRT implantation

    The activation time will be measured in 16 different device programming settings

    The measurements will be done at Day 1

Study Arms (1)

Device programming

EXPERIMENTAL

according to different settings from the SyncAV algorithm

Device: Device programming

Interventions

Device programmingDEVICE

Non-invasive electrophysiology with 65 ECG leads will be performed in 16 different device programming

Device programming

Eligibility Criteria

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

You may qualify if:

  • patients after successful implantation of a CRT-D or CRT-P device in whom a cardiac magnetic resonance examination is possible and the device is equipped with the SyncAV® programming software
  • left bundle branch block before CRT implantation
  • PQ interval ≤ 250 ms before implantation

You may not qualify if:

  • high-grade AV block
  • any contraindication concerning a safe CMR performance including claustrophobia
  • terminal heart failure (NYHA IV) or cardiac decompensation
  • life expectancy \< 1 year
  • women with child-bearing potential, pregnancy
  • drug abusus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Wolfgang Dichtl, MD PhD

    Medical University Innsbruck

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wolfgang Dichtl, MD PhD

CONTACT

004351250481388dichtl@me.com

Fabian Barbieri, MD

CONTACT

004351250482546fabian.barbieri@i-med.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2020

First Posted

December 10, 2020

Study Start

January 1, 2020

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)