Comparing two treatments for elderly patients with persistent atrial fibrillation
Pulmonary-vein Isolation or Ablation of Atrioventricular-node and Pacemaker Implantation for Elderly Patients with Persistent Atrial Fibrillation (ABLATE Versus PACE)
NA · St. Josefs-Hospital Wiesbaden GmbH · NCT04906668
This study is testing two different treatments for older patients with ongoing atrial fibrillation to see which one helps them feel better and stay out of the hospital.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 196 (estimated) |
| Ages | 75 Years to 99 Years |
| Sex | All |
| Sponsor | St. Josefs-Hospital Wiesbaden GmbH (other) |
| Locations | 13 sites (Innsbruck and 12 other locations) |
| Trial ID | NCT04906668 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares two treatment options for elderly patients aged 75 and older with persistent atrial fibrillation: pulmonary vein isolation (PVI) and atrioventricular (AV) node ablation combined with pacemaker implantation. The study aims to evaluate the effectiveness of these interventions in reducing rehospitalizations and improving quality of life. Participants will be randomly assigned to one of the two treatment groups, and their outcomes will be monitored over time. The trial focuses on patients with normal ejection fraction who continue to experience symptoms despite medical therapy.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 75 years and older with persistent atrial fibrillation who experience significant symptoms despite appropriate medical treatment.
Not a fit: Patients with impaired left ventricular function, high-grade valvular disease, or those who have contraindications for the proposed treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for managing atrial fibrillation in elderly patients, potentially reducing hospitalizations and improving their quality of life.
How similar studies have performed: Other studies have shown varying success with similar approaches, but this trial specifically targets an older population with unique challenges in managing atrial fibrillation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Persistent AF according to current ESC guideline (2020) * Symptoms EHRA classification II - IV despite guideline indicated medical therapy * Age ≥ 75 years * Capability of giving written informed consent Exclusion Criteria: * impaired systolic left ventricular function (ejection fraction \< 50%) * High-grade (III°) left cardiac valvular disease * pre-implanted pacemaker * bradycardia-indication for pacemaker * Surgical coronary revascularization (within the last 90 days) or current triple therapy after stent PCI * contraindication for PVI or pacemaker-implantation * contraindication for oral anticoagulation * body-mass-index BMI \> 40 kg/m2 * inability to give written informed consent * concomitant participation in another registered trial * life expectancy \< 12 months * reversible cause of AF (e.g. thyrotoxicosis, alcohol ingestion)
Where this trial is running
Innsbruck and 12 other locations
- Universitätsklinikum Innsbruck — Innsbruck, Austria (RECRUITING)
- Kerckhoff-Klinik Bad Nauheim — Bad Nauheim, Germany (RECRUITING)
- Universitätsklinikum Essen — Essen, Germany (RECRUITING)
- Universitätsklinikum Frankfurt am Main — Frankfurt, Germany (NOT_YET_RECRUITING)
- Klinikum Fürth — Fürth, Germany (RECRUITING)
- Ev. Krankenhaus Hagen-Haspe — Hagen, Germany (RECRUITING)
- Westpfalz-Klinikum Kaiserslautern — Kaiserslautern, Germany (RECRUITING)
- Herz-Zentrum Bodensee — Konstanz, Germany (RECRUITING)
- Krankenhaus Landshut-Achdorf — Landshut, Germany (NOT_YET_RECRUITING)
- St. Marien Hospital Lünen — Lünen, Germany (RECRUITING)
- BG Murnau — Murnau Am Staffelsee, Germany (RECRUITING)
- Universitätsklinikum Münster — Münster, Germany (RECRUITING)
- St. Josefs-Hospital Wiesbaden GmbH — Wiesbaden, Germany (RECRUITING)
Study contacts
- Principal investigator: Joachim Ehrlich, MD — St. Josefs-Hospital Wiesbaden GmbH
- Study coordinator: Joachim Ehrlich, MD
- Email: jehrlich@joho.de
- Phone: + 49 6111771201
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrial Fibrillation