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Bradycardia clinical trials

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NCT ID: NCT06115980 Active, not recruiting - Bradycardia Clinical Trials

Safety and Preliminary Performance of Xtrac O.S. System for Lead Extraction.

XTR
Start date: August 27, 2023
Phase: N/A
Study type: Interventional

This is an open label, interventional, feasibility, prospective, multicenter, clinical trial of lead extraction. The Xtrac O.S. system is intended for transvenous removal of pacing or defibrillator leads, having an inner lumen, through a superior approach. A total of 15 patients, who are scheduled for CIED lead extraction, will be recruited in order to ensure a total of at least 10 patients finishing the study procedures and follow up.

NCT ID: NCT05887323 Active, not recruiting - Heart Failure Clinical Trials

LBBAP Data Collection Registry

Start date: April 25, 2023
Phase:
Study type: Observational

The purpose of this registry is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients already implanted with the Tendril STS 2088 lead.

NCT ID: NCT05610176 Active, not recruiting - Heart Failure Clinical Trials

BIO|CONCEPT.Amvia Study

Start date: November 23, 2022
Phase: N/A
Study type: Interventional

The goal of this exploratory study is to test the preliminary safety and product performance of the new Amvia/Solvia pacemaker family in subjects that require a pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation. The study will be conducted at sites in Australia and New Zealand. It is planned to include 50 subjects in the study. Participants will visit sites at enrollment in the study, at implantation, pre-hospital discharge, 1- 3- and 12-month follow-up visits. At the visits the device will be interrogated and standard device measurements including those related to special features will be performed to assess the functionality of the device. Programming of the pacemakers will be done according to the participant´s therapeutical needs.

NCT ID: NCT05252702 Active, not recruiting - Bradycardia Clinical Trials

Aveir DR i2i Study

Start date: February 2, 2022
Phase: N/A
Study type: Interventional

Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveirâ„¢ Dual-Chamber (DR) Leadless Pacemaker system.

NCT ID: NCT05251363 Active, not recruiting - Bradycardia Clinical Trials

BIOTRONIK Conduction System Pacing With the Solia Lead

BIO-CONDUCT
Start date: December 12, 2022
Phase: N/A
Study type: Interventional

The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia S pacing lead when implanted in the left bundle branch (LBB) area. Safety will be assessed by evaluating serious adverse device effects that occur through 3 months post-implant. Efficacy will be assessed by evaluating implant success rate.

NCT ID: NCT04981353 Active, not recruiting - Clinical trials for Numerical Rating Pain Score

Thoracic Erector Spinae Plane Block for Painless 1st Stage Normal Vaginal Delivery: Randomized Controlled Study

Start date: July 5, 2021
Phase: N/A
Study type: Interventional

this study will test a novel indication for bilateral erector spinae plane block (painless 1st stage normal vaginal delivery) it depends on the hypnosis that the erector spinae plane block blocks the visceral pain also by affecting the ventral rami, dorsal rami and rami communicants.

NCT ID: NCT04632641 Active, not recruiting - Atrial Fibrillation Clinical Trials

Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial

SAFE-VEIN
Start date: April 23, 2021
Phase: N/A
Study type: Interventional

Primary objective: To compare the safety and efficacy of closure strategies post venous access procedures. Hypothesis: We anticipate that the use of a venous closure device will decrease the time to hemostasis (TTH), time to ambulation (TTA) and time to discharge (TTD) compared to conventional methods of closure following venous access procedure.

NCT ID: NCT04559945 Active, not recruiting - Bradycardia Clinical Trials

The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System

Start date: November 13, 2020
Phase: N/A
Study type: Interventional

prospective, non-randomized, multi-center, international clinical study is designed to confirm the safety and effectiveness of the Aveir LP System in a subject population indicated for a VVI(R) pacemaker.

NCT ID: NCT04253184 Active, not recruiting - Bradycardia Clinical Trials

Micra AV Transcatheter Pacing System Post-Approval Registry

Micra AV PAS
Start date: February 8, 2020
Phase:
Study type: Observational [Patient Registry]

Medtronic is sponsoring the Micra AV Registry using the Micra AV system for continued surveillance of chronic atrioventricular synchronous pacing as intended, through the collection of data based on routine clinical care practice, following commercial release. The Micra AV Registry is conducted within Medtronic's Product Surveillance Registry (PSR) platform.

NCT ID: NCT04235491 Active, not recruiting - Bradycardia Clinical Trials

Longitudinal Coverage With Evidence Development Study on Micra AV Leadless Pacemakers (Micra AV CED)

Start date: February 6, 2020
Phase:
Study type: Observational

The primary purpose of the study is to meet the CMS mandated Coverage with Evidence Development requirement in the National Coverage Determination for Leadless Pacemakers as they apply to Medtronic Micra devices. The study uses administrative claims data of the Medicare population implanted with Micra AV leadless pacemakers or dual-chamber transvenous pacemakers. Patients are enrolled through submission of claims or encounter data to CMS.