TerminatedNot Applicable

Left Bundle Area Versus Selective His Bundle Pacing

Stopped: slow enrollment

United States9 participantsStarted 2019-10-07

Plain-language summary

This is a voluntary research study to find out which location in the heart a pacemaker wire is the most efficient for a patient's heart and for battery life. Patients who volunteer and are eligible for the study will be randomized to receive one of two positions for the wire to be screwed into, in addition to studying multiple positions in the heart during the pacemaker insertion. Enrolled patients will be in the study for 1 year. They will also have an Ultrasound of their heart performed to assess how the pacemaker wire is affecting their heart. Pacemakers are connected to the heart by wires that are screwed into the heart. The wires can be connected to the heart in different places, which can affect how well the heart beats over time. The typical position is at the tip of the heart. This position may cause the heart to beat inefficiently. Over time, this could lead to weakened heart muscle, irregular heart rhythm, and more hospitalizations. The heart has special muscle cells and fibers that carry electrical signals through and around the heart. An alternative spot to place the pacemaker wire is in an area where these special cells are grouped together (called the HIS bundle). The pacemaker wire can be connected to the heart at a location which may allow the heart to beat more efficiently when compared to putting the wire at traditional spots in the heart (called HIS bundle pacing). However, sometimes connecting the wire into the HIS bundle may cause the pacemaker battery to wear out faster. Physicians can also connect the pacemaker wired near the HIS bundle (called Left left Bundle bundle area pacing). The study physicians hope this will allow the heart to beat more efficiently without causing the battery to wear out faster. The study physicians would like to study how different wire positions change heart beat efficiency and how long the pacemaker battery lasts when the wires are placed in different locations. This study will connect the pacemaker wire at either the HIS Bundle or the left bundle area pacing, to see how effectively the heart pumps and how much battery is being used.

Who can participate

Age range19 Years

SexALL

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Inclusion criteria

✓. Over 18 years old.
✓. With signed consent.
✓. Pacemaker indication according to 2018 American College of Cardiology/American Heart Association/Heart Rhythm Society Guideline on the Evaluation and Management of Patients with Bradycardia and Cardiac Conduction Delay. With one or both of the following:
✓. Symptomatic sinus node dysfunction.
✓. Symptomatic Atrioventricular (AV) block or high degree AV block.
✓. Tachy-Brady syndrome

Exclusion criteria

✕. Previously implanted cardiac pacing devices except transvenous temporary pacemaker.
✕. Patients who are eligible for appropriate cardiac resynchronization therapy(CRT) or implantable cardiovert defibrillator (ICD) implantation
✕. Patients with prior septal myectomy
✕. Patients with prior surgical or transcatheter aortic valve replacement

What they're measuring

Ventricular Capture Threshold, 3 Months Unipolar or Bipolar

Timeframe: 3 months

Trial details

NCT IDNCT04093414

SponsorDavid Haines, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-14

Results submitted2022-06-09

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