NCT01970423

Brief Summary

Cardiac resynchronization therapy may reduce central sleep apnea, but there is no prospective randomized study so far demonstrating such an effect in patients with conventional pacemaker undergoing upgrading to CRT because of heart failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

October 22, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 28, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

6.6 years

First QC Date

October 22, 2013

Last Update Submit

September 2, 2020

Conditions

Cardiomyopathy

Keywords

Patients with pacemaker or ICD therapy

Outcome Measures

Primary Outcomes (2)

  • Improvement of central sleep apnea

    improvement of moderate / severe central sleep apnea (AHI ≥ 15/h) due to new onset CRT as compared to ongoing conventional right ventricular pacing

    January 2014 - June 2021

  • Validation of the AP scan by the gold standard polysomnography

    January 2014 - June 2021

Secondary Outcomes (1)

  • CRT response

    January 2014 - June 2021

Study Arms (2)

CRT

OTHER

After randomization and polysomnography the CRT will get activated. After 3-5 months cross over to conventional right ventricular stimulation.

Device: CRT

Right Ventricular Stimulation

OTHER

After randomization and polysomnography the conventional right ventricular stimulation will get activated. After 3-5 months cross over to CRT activation.

Device: conventional right ventricular stimulation

Interventions

CRTDEVICE

The new device is the first CRT-P that relies on a physiological parameter, respiration, to allow the pacemaker to follow the patient's breath and help create an appropriate pacing rate.

Also known as: INLIVEN / VISIONIST (Boston Scientific), INCEPTA / AUTOGEN (Boston Scientific)
CRT
conventional right ventricular stimulationDEVICE
Right Ventricular Stimulation

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • left ventricular ejection fraction \< 50%
  • implanted conventional pacemaker or ICD with a right ventricular pacing rate \> 40% or planned "ablate and pace" therapy
  • age 40 - 85 years

You may not qualify if:

  • NYAH IV
  • liver cirrhosis
  • renal insufficiency (GFR \< 30ml/min/1,73m²)
  • expectancy of life \< 1 year
  • premenopausal woman
  • drug or substance abuse
  • hyperthyreosis
  • custodianship
  • CM allergy
  • any condition that may compromise the compliance of the patient, or would preclude the patient from successful completion of the study
  • plaster allergy
  • enrollment in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical University Innsbruck, Department for Internal Medicine III

Innsbruck, 6020, Austria

Location

Medical University Innsbruck, Internal Medicine III (Cardiology & Angiology)

Innsbruck, 6020, Austria

Location

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Wolfgang Dichtl, MD

    Medical University of Innsbruck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Priv.-Doz. DDr.

Study Record Dates

First Submitted

October 22, 2013

First Posted

October 28, 2013

Study Start

January 1, 2014

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

September 3, 2020

Record last verified: 2020-09

Locations

AU(2)