REmodeling the Left Ventricle With Atrial Modulated Pacing
Status: | Recruiting |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 2/21/2019 |
Start Date: | September 15, 2017 |
End Date: | December 2019 |
Contact: | REVAMP Clinical Study Manager |
Email: | medtronicCRMtrials@medtronic.com |
Phone: | 1-800-328-2518 |
New therapy tested in heart failure with preserved ejection fraction (HFpEF) patients with
approved indications for pacing to determine if elevated pacing therapy is tolerated and
whether there is a signal for efficacy.
approved indications for pacing to determine if elevated pacing therapy is tolerated and
whether there is a signal for efficacy.
Inclusion Criteria:
- Subject has had a market released dual chamber Medtronic Pacemaker with a Sleep
function for at least 3 months
- Subject is stable on current medications
- Subject has dyspnea with exertion or diagnosed as NYHA Class II or III Heart Failure
- Subject has had a prior Echo in past 6 months with: EF ≥ 50% and Diastolic volume <80
ml/m²
- Subject has evidence of hypertrophy (indexed to body surface area: men 115 g/m², women
95 g/m² or indexed to height: men 49.2 g/m2.7, women 46.7 g/m2.7) or Relative Wall
thickness >0.42, or Wall Thickness>1.2cm (posterior wall)
- Subject is willing to sign and date the study Informed Consent Form (IC Form) -
Subject is 18 years of age or older, or of legal age to give informed consent per
local law
- Subject is expected to remain available for follow-up visits
Exclusion Criteria:
- Subject has permanent AF or AF noted on baseline interrogation rhythm strip
- Subject has uncontrolled BP; (systolic pressure needs to be >100mmHg and <160mmHg on
medications)
- Subject has severe stenosis of the aortic or mitral valve, defined as valve area ≤1.0
cm² or severe regurgitation of the aortic or mitral valve
- Subject has symptomatic Chronic Obstructive Pulmonary Disease (COPD) requiring oxygen
- Subject's Pacemaker has less than 6 months of Pacemaker battery life
- Subject had an aortic valve replacement (surgical or TAVR) procedure less than 9
months prior to enrollment
- Subject's programmed upper rate limit is less than 100 bpm because of concerns of
elevated pacing
- Subject is unable or unwilling to perform the 6 Minute Walk Test at all scheduled
study visits
- Subject is currently enrolled or planning to enroll in a potentially confounding trial
during the course of the study (co-enrollment in concurrent studies is only allowed
when documented pre-approval is obtained from the Medtronic study manager)
- Subject is pregnant
- Subject meets any exclusion criteria required by local law
- Subject's life expectancy is less than 12 weeks
- Subject with medical condition that precludes the patient from participation in the
opinion of the investigator
- Subject has known coronary disease with Class II angina
We found this trial at
10
sites
410 W 10th Ave
Columbus, Ohio 43210
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Rami Kahwash
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Deepak Gupta
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
Click here to add this to my saved trials
Charleston, South Carolina 29425
Principal Investigator: Sheldon Litwin
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
Chicago, Illinois 60611
Principal Investigator: Sanjiv Shah
Click here to add this to my saved trials
Click here to add this to my saved trials
555 N Duke St
Lancaster, Pennsylvania 17602
Lancaster, Pennsylvania 17602
(717) 544-5511
Principal Investigator: Amit Varma
Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
Click here to add this to my saved trials
2450 Riverside Ave
Minneapolis, Minnesota 55454
Minneapolis, Minnesota 55454
(612) 273-3000
Principal Investigator: IIknur Can
Phone: 612-624-7178
University of Minnesota Medical Center, Fairview Improving patients' lives drives the innovation that makes University...
Click here to add this to my saved trials
Stockton, California 95204
Principal Investigator: Cyrus Buhari
Phone: 209-461-5257
Click here to add this to my saved trials
Tucson, Arizona 85724
Principal Investigator: Mark Friedman
Click here to add this to my saved trials
Click here to add this to my saved trials