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क्लिनिकल ट्रायल NCT07209852 (SEPTA PMCF) के लिए ब्रैडीकार्डिया, एट्रियोवेंट्रिकुलर ब्लॉक, साइनस नोड विकार, बंडल-ब्रांच ब्लॉक वर्तमान में भर्ती जारी है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें।
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कार्ड दृश्य

Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up (SEPTA PMCF) 140 अवलोकनात्मक

भर्ती जारी
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT07209852 (SEPTA PMCF) एक अवलोकनात्मक चिकित्सकीय अध्ययन है जो ब्रैडीकार्डिया, एट्रियोवेंट्रिकुलर ब्लॉक, साइनस नोड विकार, बंडल-ब्रांच ब्लॉक से जुड़ा हुआ है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 19 दिसंबर 2025 को हुई थी, और इसमें कुल 140 प्रतिभागियों के नामांकन की योजना है। Boston Scientific इस परीक्षण का नेतृत्व कर रहे हैं और इसके 31 अगस्त 2029 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 17 मार्च 2026 को अंतिम बार अपडेट की गई थी
संक्षिप्त सारांश
The goal of this observational post-market clinical Follow-up study is to learn about the long-term safety, performance, and clinical benefits of pacing the left bundle branch area (LBBAP) using the INGEVITY+ pacemaker lead in patients with bradycardia who need a pacemaker.
आधिकारिक शीर्षक

Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up (SEPTA PMCF)

स्वास्थ्य स्थितियां
ब्रैडीकार्डियाएट्रियोवेंट्रिकुलर ब्लॉकसाइनस नोड विकारबंडल-ब्रांच ब्लॉक
अन्य अध्ययन आईडी
  • SEPTA PMCF
  • SEPTA PMCF - C2211
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2025-12-19
अंतिम अद्यतन प्रकाशित
2026-03-17
अध्ययन की समाप्ति तिथि (अनुमानित)
2029-08-31
नामांकन (अनुमानित)
140
अध्ययन प्रकार
अवलोकनात्मक
स्थिति
भर्ती जारी
प्रमुख शब्द
Left Bundle Branch Area Pacing (LBBAP)
INGEVITY+ Lead
Pacemaker
Cardiac Pacing
Conduction System Pacing
Ventricular Synchrony
Post-Market Clinical Follow-up
समूह/हस्तक्षेप
प्रतिभागी समूह/शाखाहस्तक्षेप/उपचार
Patients receiving INGEVITY+ lead for left bundle branch area pacing
This group includes adult patients with bradycardia who are indicated for a Boston Scientific pacemaker system. All participants will undergo implantation of an INGEVITY+ pace/sense lead in the left bundle branch area (LBBAP) with a compatible Boston Scientific pacemaker.
Pacemaker lead
The pacemaker lead under investigation is a bipolar, steroid-releasing pacemaker electrode with active fixation (IS-1 connection) designed for chronic stimulation and sensing in the right atrium, right ventricle or left bundle branch area (LBBA). In this study, the lead is implanted in the LBBA and connected to a single- or dual-chamber pacemaker. Implantation is performed using a compatible, CE-marked catheter for p...और दिखाएँ
प्राथमिक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
LBBA Implant Success Rate
Percentage of subjects in whom the INGEVITY+ lead is successfully implanted in the left bundle branch area (LBBA). Implant success is determined by ECG and procedural criteria, as defined per protocol.
At the time of implant procedure (Day 0).
Maintenance of Ventricular Synchrony (Paced QRS Duration)
Mean paced QRS duration measured by 12-lead ECG to assess preservation of ventricular synchrony.
From implant through 3-year follow-up.
भागीदारी सहायक
पात्रता मानदंड

अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
  1. Subjects intended to undergo initial (de novo) pacing system implant using the INGEVITY+ lead in the left bundle branch area (LBBA) and a Boston Scientific single or dual- chamber pacemaker (Note: no prior attempted pacing system components);

  2. Subjects who are indicated for and will receive a Boston Scientific pacemaker system (including the single or dual chamber pacemaker and an INGEVITY+ lead in the LBBA location) for one of the following medical conditions:

    1. Symptomatic paroxysmal or permanent second- or third-degree AV block,

    2. Symptomatic bilateral bundle branch block,

    3. Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial \[SA\] block),

    4. Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias,

    5. Neurovascular (vasovagal) syndromes or hypersensitive carotid sinus syndromes,

    6. Adaptive-rate pacing for patients exhibiting chronotropic incompetence and who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or level of physical activity.

      Dual-chamber and atrial tracking modes are also indicated for patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of the following:

    7. Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block,

    8. VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm,

    9. Low cardiac output or congestive heart failure secondary to bradycardia;

  3. Subjects willing and capable of providing informed consent and participating in all testing and clinic visits associated with the clinical study at an approved clinical study location and at the intervals defined by protocol;

  4. Subjects who are ≥18 years of age, and of legal age to give informed consent specific to state and national law.

  1. Subjects meeting guideline indications for cardiac resynchronization therapy (CRT) in the absence of a bradycardia indication;
  2. Subjects with a known or suspected sensitivity to dexamethasone acetate (DXA);
  3. Subjects with a Mechanical Tricuspid Valve;
  4. Subjects requiring hemodialysis or peritoneal dialysis;
  5. Subject has or has had implanted any pacemaker, ICD system, including subcutaneous, transvenous or leadless systems (Note: except for temporary pacing wire at time of enrollment) or CRT system;
  6. Subjects currently on an active organ transplant list;
  7. Subject referred to or admitted for hospice care;
  8. Subjects with a documented life expectancy of less than 12 months;
  9. Subjects enrolled in any other concurrent study (unless prior approval is received from the Sponsor);
  10. Subjects who are, or plan to become pregnant during the course of the study or are breastfeeding at time of enrollment;
  11. Subjects who are unable or unwilling to comply with the follow-up schedule, including those living at such a distance from the investigational site that attending follow-up visits would be unusually difficult or burdensome.
Boston Scientific Corporation logoBoston Scientific
अध्ययन केंद्रीय संपर्क
संपर्क: Jens Goetzke, Dipl.-Ing. (FH), 800-227-3422, [email protected]
संपर्क: Gena Kantor, MPH, 800-227-3422, [email protected]
13 7 देशों में अध्ययन स्थान
St. Jan-Hospital, Bruges, 8000, Belgium
Jean-Benoît Le Polain De Waroux, MD, संपर्क, +3250, [email protected]
भर्ती जारी
Clinique Saint-Pierre Ottignies-Hospital, Brussels, 1340, Belgium
Aurélien Wauters, MD, संपर्क, +3210, [email protected]
भर्ती जारी
CHRU de Lille, Lille, 59037, France
Christelle Marquié, MD, संपर्क, [email protected]
अभी भर्ती शुरू नहीं
Hospital Europeen Georges-Pompidou (HEGP), Paris, 75908, France
Pierre Baudinaud, MD, संपर्क, +33 1 56 09 20 00, [email protected]
अभी भर्ती शुरू नहीं

Lower Saxony

Marienhospital-Hospital, Osnabrück, Lower Saxony, 49074, Germany
Dirk Amelingmeyer, MD, संपर्क, +49 541 3260, [email protected]
अभी भर्ती शुरू नहीं

Saarland

Saarland University Hospital, Homburg, Saarland, 66421, Germany
Amr Abdin, MD, संपर्क, +496841, [email protected]
अभी भर्ती शुरू नहीं

Emilia-Romagna

Azienda Ospedaliero-Universitaria di Ferrara-Hospital, Ferrara, Emilia-Romagna, 44100, Italy
Matteo Bertini, MD, PhD, संपर्क, +39 532 236111, [email protected]
अभी भर्ती शुरू नहीं
Azienda Ospedaliera Ospedale Niguarda Ca Granda, Milan, 20162, Italy
Matteo Baroni, MD, संपर्क, +39 02 6444 7791, [email protected]
अभी भर्ती शुरू नहीं
AOU Maggiore, Novara, 28100, Italy
Federica De Vecchi, MD, संपर्क, +39 0321, [email protected]
अभी भर्ती शुरू नहीं
Virgen de las Nieves University Hospital, Granada, 18014, Spain
Manuel Molina Lerma, MD, संपर्क, +34 958 020 000, [email protected]
अभी भर्ती शुरू नहीं
Hospital Clinico Universitario Lozano Blesa, Zaragoza, 50009, Spain
Javier Ramos Maqueda, MD, संपर्क, +34 976 76 57 00, [email protected]
भर्ती जारी
Inselspital Bern, Bern, 3010, Switzerland
Andreas Häberlin, Prof., MD, संपर्क, +41 31 632 50 00, [email protected]
अभी भर्ती शुरू नहीं

Surrey

East Surrey Hospital, Redhill, Surrey, RH1 5RH, United Kingdom
Cheuk Chan, MD, संपर्क, +44 1737 768511, [email protected]
अभी भर्ती शुरू नहीं