REmodeling the Left Ventricle With Atrial Modulated Pacing

Heart Failure Clinical Trial

— REVAMP  

Official title:

REmodeling the Left Ventricle With Atrial Modulated Pacing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03210402
• Other study ID #: REVAMP
• Status: Completed
• Phase: N/A
• Start date: September 15, 2017
• Est. completion date: March 15, 2021

Study information

• Verified date: April 2021
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Elevated night pacing on
Device will be programmed to 100 beats per minute (bpm) for five hours during normal sleep times
• Elevated night pacing off
Device will be programmed to normal lower rates

Locations

Country	Name	City	State
United States	Medical University of South Carolina (MUSC)	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	The Lindner Research Center	Cincinnati	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	University of Minnesota Medical Center Fairview	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	St Joseph's Medical Center	Stockton	California
United States	University of Arizona - Sarver Heart Center	Tucson	Arizona
United States	Lourdes Cardiology Services	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant's Ability to Tolerate Therapy	Participant's Ability to Tolerate Night Heart Pacing. The outcome of interest is the proportion of subjects who remain in the study. Study exit reasons will include intolerable symptoms, increase in NT-proBNP levels, decrease in LVEF or increase in troponin. The proportion of subjects remaining in study will be calculated along with the lower bound of the one-sided 95% confidence interval.	Baseline through 12 week follow-up