First Degree AV Block
Conditions
Keywords
Implantable ICD, First Degree AV block
Brief summary
The objective of the trial is to observe the effects of restoring atrioventricular (AV) synchrony in subjects with prolonged PR intervals. This will be assessed both acutely and chronically using echocardiographic and functional measurements.
Detailed description
Same as above.
Interventions
Device programming that modifies AV timing
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meet current indications for an implantable cardioverter-defibrillator (ICD) implant with: * QRS width \< 120 msec * Left ventricular ejection fraction (LVEF) \< 35% (no more than 180 days prior to enrollment) * NYHA functional class II/III * Optimal pharmacological heart failure therapy * PR interval \>/= 230 msec * Ability to tolerate protocol required programming * Access to a telephone line compatible with the LATITUDE® Communicator * Subjects in sinus rhythm at the time of the baseline visit and who are expected to remain in sinus rhythm for the duration of the study * Age 18 or above, or of legal age to give informed consent specific to state and national law * Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational center and return to the investigational center at the intervals defined by this protocol
Exclusion criteria
* Previously placed pacemaker, ICD, or CRT device * Inability or refusal to sign the Informed Consent Form * Documented life expectancy of less than 12 months or expected to undergo heart transplant within the next 12 months * Have tricuspid valve disease or who are likely to receive a mechanical tricuspid valve during the course of the clinical investigation * Inability or refusal to comply with the follow-up schedule * Have a neuromuscular, orthopedic, or other noncardiac condition that prevents subject from normal unsupported walking for the six minute hall walk test * Have surgically uncorrected primary valvular heart disease * Second or third degree atrioventricular block (AVB) * Permanent or persistent atrial tachyarrhythmia that is refractory to all therapies * Have had cardiac surgery, percutaneous coronary intervention, or myocardial infarction within 3 months of signing consent or who are likely to undergo a cardiac surgery or procedure in the foreseeable future * Enrolled in any concurrent study unless written approval has been obtained from Boston Scientific or The Integra Group * Women who are pregnant or plan to become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Range Finding of Functional and Hemodynamic Changes Using Echocardiographic Determined Measures. | 6 months | Echocardiographic measures will include, but not be limited to, left ventricular volumes, left ventricular diameters, and ejection fraction. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Device Programming Modifies AV Timing DDD-40-BiV
Cardiac resynchronization therapy-defibrillator: Device programming that modifies AV timing | 1 |
| Device Programming Allows Intrinsic AV Timing. VVI-40-RV | 1 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study terminated | 1 | 1 |
Baseline characteristics
| Characteristic | Device Programming Modifies AV Timing | Device Programming Allows Intrinsic AV Timing. | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 1 participants | 1 participants | 2 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 1 / 1 | 1 / 1 |
| serious Total, serious adverse events | 1 / 1 | 0 / 1 |
Outcome results
Primary
Range Finding of Functional and Hemodynamic Changes Using Echocardiographic Determined Measures.
Echocardiographic measures will include, but not be limited to, left ventricular volumes, left ventricular diameters, and ejection fraction.
Time frame: 6 months
Population: The study was terminated early: long PR intervals are relatively rare in this population, and it would take an inordinately long time to enroll sufficient patients. Because of the early termination of the study, no data was analyzed since the primary objective is underpowered.
| Arm | Measure | Value |
|---|---|---|
| Device Programming That Modifies AV Timing | Range Finding of Functional and Hemodynamic Changes Using Echocardiographic Determined Measures. | 0 |
| Device Programming That Allows Intrinsic AV Timing. | Range Finding of Functional and Hemodynamic Changes Using Echocardiographic Determined Measures. | 0 |