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NCT03839121: BIO|REDUCE
Safety and Performance Aspects of CRT-DX System in Patients With Sinus Rhythm
trial testing Cardiac Resynchronization Therapy (CRT) in Heart Failure in 113 participants. Completed in 8 June 2023.
8 June 2023
Quick facts
| Lead sponsor | Biotronik SE & Co. KG |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 113 |
| Start date | 1 April 2019 |
| Primary completion | 8 June 2023 |
| Estimated completion | 8 June 2023 |
| Sites | 21 locations across Austria, Germany, Hungary, Czechia |
Drugs / interventions tested
- Cardiac Resynchronization Therapy (CRT)
Conditions studied
- Heart Failure — all drugs for Heart Failure →
- Cardiac Resynchronization Therapy — all drugs for Cardiac Resynchronization Therapy →
Sponsor
Biotronik SE & Co. KG — full company profile →
Who can join
18 and older, any sex, with Heart Failure or Cardiac Resynchronization Therapy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The conventional CRT-D system consists of 3 leads in patients with Heart Failure (HF). A part of HF patients have non-impaired sinus node function and will not be stimulated in the right atrium. The implantation of the right atrial lead, which is not mandatory in these patients, harbors potential complication risks and prolongs implantation procedure. The new CRT-DX system uses 2 leads only: a right ventricular lead extended with floating RA sending dipole and a left ventricular lead. The aim of the BIO\|REDUCE study is to assess the residual safety and performance aspects of the CRT-DX system within 12 months follow-up in HF patients with an indication for a CRT-D, sinus rhythm, and no need for an atrial lead implantation.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Biventricular Cardiac Resynchronization Therapy with Atrial Sensing but No Atrial Lead: A Prospective Registry of Patients, Complications, and Therapy Responses.
Kolb C, Zima E, Arnold M, Fedorco M, et al · · 2025 · cited 1× · PMID 40725698 · DOI 10.3390/jcm14145009
Verify or expand the search:
- PubMed search for NCT03839121
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Cardiac Resynchronization Therapy (CRT)
Trials testing the same drug.
- NCT03366545 — Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices · active not recruiting
- NCT03077139 — Cardiac Resynchronization Therapy in Pulmonary Hypertension · NA · completed
Other recruiting trials for Heart Failure
Currently open trials in the same condition.
- NCT06118983 — Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF) · NA · recruiting
- NCT07496372 — Efficacy and Safety of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart · Phase 3 · recruiting
- NCT07527156 — Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure · Phase 4 · recruiting
- NCT07263035 — Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure · Phase 4 · recruiting
- NCT07531966 — Vascular Complications After Kidney Transplantation · recruiting
Other Biotronik SE & Co. KG trials
Trials by the same sponsor.
- NCT07393009 — Studying Routine Patient Care With BIOTRONIK Devices That Allow a More Natural Heart Stimulation · not yet recruiting
- NCT06989580 — BIO|CONCEPT.BIOMONITOR-HF Collect Clinical Data From Heart Failure Patients Using BIOMONITOR Devices With a Study Specif · NA · recruiting
- NCT06018818 — Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family · NA · completed
- NCT05426785 — To Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing (BIO|ATP) · NA · recruiting
- NCT05761249 — BIOSTREAM.HF HeartInsight · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03839121 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Biotronik SE & Co. KG
- Last refreshed: 9 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03839121.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing