deltatrials
Unknown OBSERVATIONAL NCT03024047

Cohort Description of Younger With AV-block

Sponsor: University of Aarhus

Interventions Pacemaker
Updated 8 times since 2017 Last updated: Jan 13, 2017 Started: Jan 31, 2017 Primary completion: Aug 31, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03024047, this observational or N/A phase trial focuses on Atrioventricular Block and Genetic Disease and remains ongoing. Sponsored by University of Aarhus, it has been updated 8 times since 2017, reflecting limited change activity. This study contributes longitudinal data to the cardiovascular research landscape.

Study Description(click to expand)

Method: The following covariates will be reported. Date of diagnosis of AV-block: The date of diagnosis is defined as the day the physician diagnoses the AV-block. E.g. if the patient has a Holter monitoring performed, the date of diagnosis is the dag the monitoring is reviewed. Reported as: Day-month-year Comorbidity at day of first pacemaker implant: Registered as one or more of the following: 1. Diabetes 2. Hypertension 3. Hypercholesterolemia 4. Heart failure 5. Atrial fibrillation or flutter 6. Ischemic heart disease 7. Sarcoidosis 8. Connecting tissue disorder 9. Other Smoking status at day of first pacemaker implant: Registered as: Current, former, never Device selected at first pacemaker implant: Registered as: DDD, CTR, etcetera Genetic investigation: Is there performed genetic investigation due to the finding of AV-block? Investigation must be initiated maximum 4 weeks after day of first pacemaker implant. Registered as: y/n. Date of first pacemaker implant: Registered as: Day-month-year Implant sight ECG 12 description: ECG 12 must be taken maximum one week before day of first pacemaker implant Registered as: Bpm., RBBB y/n, LBBB y/n, PR in msec, QRS in msec, QT in msec, QTc in msec (Frederica) Implant indication: Registered as one of following: 1. First-degree atrioventricular...

Method:

The following covariates will be reported.

Date of diagnosis of AV-block:

The date of diagnosis is defined as the day the physician diagnoses the AV-block. E.g. if the patient has a Holter monitoring performed, the date of diagnosis is the dag the monitoring is reviewed.

Reported as: Day-month-year

Comorbidity at day of first pacemaker implant:

Registered as one or more of the following:

1. Diabetes 2. Hypertension 3. Hypercholesterolemia 4. Heart failure 5. Atrial fibrillation or flutter 6. Ischemic heart disease 7. Sarcoidosis 8. Connecting tissue disorder 9. Other

Smoking status at day of first pacemaker implant:

Registered as: Current, former, never

Device selected at first pacemaker implant:

Registered as: DDD, CTR, etcetera

Genetic investigation:

Is there performed genetic investigation due to the finding of AV-block? Investigation must be initiated maximum 4 weeks after day of first pacemaker implant.

Registered as: y/n.

Date of first pacemaker implant:

Registered as: Day-month-year

Implant sight

ECG 12 description:

ECG 12 must be taken maximum one week before day of first pacemaker implant Registered as: Bpm., RBBB y/n, LBBB y/n, PR in msec, QRS in msec, QT in msec, QTc in msec (Frederica)

Implant indication:

Registered as one of following:

1. First-degree atrioventricular block with symptoms 2. Mobitz type 1 with symptoms 3. Mobitz type 2 4. Advanced second-degree atrioventricular block 5. Third-degree atrioventricular block 6. Unknown The most malignant is chosen and it is reported if it is intermittent or persistent.

Symptoms:

Registered as one or more of following:

1. Dyspnoea 2. Fatigue 3. Malaise 4. Dizziness 5. Syncope 6. Angina 7. Cardiac arrest 8. No symptoms

Echocardiography:

Performed maximum two weeks before day of first pacemaker implant The reported values are what the echocardiographer describes.

Registered as:

LVEF in % (values over 60% is reported as \>60 %) Hypertrophy of LV y/n Dilatation of LV y/n Dilatation of LA y/n Valvular disease/artificial valve y/n

Coronary angiography:

At day of first pacemaker implant +/- 4 weeks

Registered as:

Normal y/n Significantly disease on LAD y/n Significantly disease on RCA y/n Significantly disease on CX y/n Significantly disease = leading to CABG, PCI or antithrombotic treatment

Status Flow

~Feb 2017 – ~Apr 2018 · 14 months · monthly snapshotNot Yet Recruiting~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotNot Yet Recruiting~Jun 2018 – ~Feb 2019 · 8 months · monthly snapshotNot Yet Recruiting~Feb 2019 – ~Jan 2021 · 23 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – present · 19 months · monthly snapshotUnknown~Jan 2026 – present · 3 months · monthly snapshotUnknown

Change History

8 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown

  2. Sep 2024 — Present [monthly]

    Unknown

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown

    Status: Unknown StatusUnknown

  4. Jan 2021 — Jul 2024 [monthly]

    Unknown Status

  5. Feb 2019 — Jan 2021 [monthly]

    Unknown Status

    Status: Not Yet RecruitingUnknown Status

Show 3 earlier versions
  1. Jun 2018 — Feb 2019 [monthly]

    Not Yet Recruiting

  2. Apr 2018 — Jun 2018 [monthly]

    Not Yet Recruiting

    Phase: NANone

  3. Feb 2017 — Apr 2018 [monthly]

    Not Yet Recruiting NA

    First recorded

Jan 2017

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • University of Aarhus
Data source: University of Aarhus

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations