Atrial Fibrillation Trial, Recruiting NCT06989580 Sponsor: Biotronik SE & Co. KG Condition: Atrial Fibrillation
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Atrial Fibrillation Trial, Recruiting

NCT06989580
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with heart failure for at least 90 days and are currently experiencing moderate symptoms (not the most mild, but not the most severe)
  • People who, in the past year, were admitted to hospital with worsening heart failure as the main reason for admission
  • OR people who had an unplanned outpatient visit in the past 6 months where their water tablet (diuretic) dose was significantly increased, or they received diuretics through a drip, or had fluid removed by a medical procedure for worsening heart failure
  • OR people who had a specific heart-related blood test (NT-proBNP or BNP) result above a certain level in the past 3 months — the exact level required depends on the person's heart pump function and heart rhythm (confirm with trial site)
  • People who are able to understand what the study involves
  • People who are willing to sign a consent form agreeing to take part
  • People who are able and willing to attend follow-up appointments at the study site and by phone
  • People who are able and willing to use a specific remote heart monitoring device called the CardioMessenger, and who accept the BIOTRONIK Home Monitoring system

Who may not be able to join:

  • People who already have a pacemaker, implantable defibrillator (ICD), cardiac resynchronisation therapy (CRT) device, or implantable cardiac monitor
  • People for whom current medical guidelines strongly recommend implanting one of those devices
  • People with a permanent or long-standing persistent irregular heart rhythm called atrial fibrillation (AF)
  • People who have had a stroke, heart attack, or certain heart procedures (coronary stenting or bypass surgery) within the past 3 months
  • People who are currently on ongoing kidney dialysis or peritoneal dialysis
  • People who have complex congenital heart disease (a heart condition present from birth that is structurally complicated)
  • People who are currently receiving chemotherapy, immunotherapy, or radiation therapy for active cancer
  • People whose life expectancy is estimated to be less than one year
  • People under 18 years of age
  • People who are already taking part in another device or drug trial that could interfere with this study or affect its results

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Thorsten Lewalter, Prof. Dr., Biotronik SE & Co. KG

Phone: +49 (0) 30 68905 1182

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Biotronik SE & Co. KG
Registry
ClinicalTrials.gov
Start date
22 August 2025
Est. completion
31 December 2028

Where this trial is recruiting

🇧🇪 Belgium 🇩🇪 Germany

Primary endpoints

Heart failure events confirmed by WHF Adjudication Committee; Arrhythmias and subsequent therapeutic interventions

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov