The CONFORM Pivotal Trial

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Conformal Medical, Inc
Study ID
NCT05147792
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CLAAS — DEVICE
    CLAAS
  • WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder — DEVICE
    WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder

Study Details

The CLAAS® device will be evaluated for safety and efficacy by establishing its performance is non-inferior to the commercially available WATCHMAN® and Amulet™ left atrial appendage closure devices in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the CLAAS device or the WATCHMAN or Amulet™ devices and will be followed for 5 years after device implant.

Key Dates

Start date
May 26, 2022
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2031

Study Design

Enrollment
1,600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: CLAAS
    Transcatheter left atrial occluder
  • Active Comparator: WATCHMAN / Amulet
    Transcatheter left atrial occluder

Primary Outcome Measure

Procedure-related complications, all-cause death, major bleeding [ Time Frame: 12 months ]

Central Contacts

Locations (76)

FacilityCityStateZIPSite coordinators
Grandview Medical CenterBirminghamAlabama35243
Anil Rajendra, MD (PRINCIPAL_INVESTIGATOR)
Abrazo Arizona Heart HospitalPhoenixArizona85016-
Arizona Heart Arrhythmia AssociatesPhoenixArizona85018
Helen Foughi
[email protected]
Akash Makkar, MD (PRINCIPAL_INVESTIGATOR)
Banner University Medical Center PhoenixPhoenixArizona85006
Wilber Su, MD (PRINCIPAL_INVESTIGATOR)
HonorHealthScottsdaleArizona85258
Ethan Ashley
[email protected]
Rahul Doshi, MD (PRINCIPAL_INVESTIGATOR)
Pima Heart & VascularTucsonArizona85719
Thomas Waggoner, DO (PRINCIPAL_INVESTIGATOR)
St. Bernard's Medical CenterJonesboroArkansas72401
Kayla Rubino
[email protected]
Devi Nair, M.D. (PRINCIPAL_INVESTIGATOR)
Loma Linda University HealthLoma LindaCalifornia92354
Tina Ramirez
[email protected]
Rahul Bhardwaj, MD (PRINCIPAL_INVESTIGATOR)
Huntington HospitalPasadenaCalifornia91105
Samia Solh
[email protected]
626-397-3883
Mayer Rashtian, MD (PRINCIPAL_INVESTIGATOR)
Pacific Heart InstituteSanta MonicaCalifornia90405
Alette Laughton
[email protected]
Shephal Doshi, M.D. (PRINCIPAL_INVESTIGATOR)
Community Memorial Hospital VenturaVenturaCalifornia93003
Marisa Grant
[email protected]
Jonathan Dukes, MD (PRINCIPAL_INVESTIGATOR)
South Denver Cardiology AssociatesLittletonColorado80120
Sarah Neilsen
[email protected]
Lee MacDonald, MD (PRINCIPAL_INVESTIGATOR)
Hartford Health Care St. Vincent's Medical CenterBridgeportConnecticut06606
Jesse Cardona
[email protected]
Edward Carreras, MD (PRINCIPAL_INVESTIGATOR)
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010
Nebu Alexander
[email protected]
Sarfraz Durrani, MD (PRINCIPAL_INVESTIGATOR)
Ascension St. Vincent's JacksonvilleJacksonvilleFlorida32204-
Largo Medical CenterLargoFlorida33770
Holly Lynn Grospitch
[email protected]
Saurabh Sanan, MD (PRINCIPAL_INVESTIGATOR)
Baptist Hospital of MiamiMiamiFlorida33176
Ramon Quesada, MD (PRINCIPAL_INVESTIGATOR)
AdventHealth OrlandoOrlandoFlorida32803
Chantie Garvey
[email protected]
Usman Siddiqui, MD (PRINCIPAL_INVESTIGATOR)
Baptist Health Care - PensacolaPensacolaFlorida32503
Bridget Lane
[email protected]
Thabet Alsheikh, MD (PRINCIPAL_INVESTIGATOR)
Sarasota Memorial Health Care SystemSarasotaFlorida34239
Kristen Sangmaster
[email protected]
941-917-2165
Robert Eckart, MD (PRINCIPAL_INVESTIGATOR)
AdventHealth TampaTampaFlorida33613
Daniel Robledo
[email protected]
Giancarlo Speziani, MD (PRINCIPAL_INVESTIGATOR)
USF - Tampa General HospitalTampaFlorida33620
Bibhu Mohanty, MD (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30342
David De Lurgio, MD (PRINCIPAL_INVESTIGATOR)
Northside Hospital, IncAtlantaGeorgia30342
Alok Gambhir, MD (PRINCIPAL_INVESTIGATOR)
Piedmont Health InstituteAtlantaGeorgia30309
Sandeep Goyal, MD (PRINCIPAL_INVESTIGATOR)
WellStar Kennestone HospitalMariettaGeorgia30062
Jennifer Cuvo
[email protected]
Amar Patel, MD (PRINCIPAL_INVESTIGATOR)
Midwest Cardiovascular InstituteNapervilleIllinois60540
Sherri McCoy
[email protected]
Moeen Saleem, MD (PRINCIPAL_INVESTIGATOR)
Ascension St. Vincent - Carmel, INIndianapolisIndiana46260-
University of IowaIowa CityIowa52242
Trisha Elliott
[email protected]
Paari Dominic, MD (PRINCIPAL_INVESTIGATOR)
University of Kansas Medical CenterKansas CityKansas66160
Grace Millington
[email protected]
Madhu Reddy, MD (PRINCIPAL_INVESTIGATOR)
Terrebone - Cardiovascular Institute of the SouthHoumaLouisiana70360
Vicky Parfait
[email protected]
Peter Fail, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins UniversityBaltimoreMaryland21287
Michele Martucci
[email protected]
Edward Powers, MD (PRINCIPAL_INVESTIGATOR)
Medstar Union Memorial HospitalBaltimoreMaryland21218
John Wang, MD (PRINCIPAL_INVESTIGATOR)
Lahey Hospital & Medical CenteerBurlingtonMassachusetts01805
Jonathan Silver, MD (PRINCIPAL_INVESTIGATOR)
Baystate Medical CenterSpringfieldMassachusetts01199
Christine Callahan
[email protected]
Andrew Goldsweig, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford St. John HospitalDetroitMichigan48236
Heather Metcalfe
[email protected]
Amir Kaki, MD (PRINCIPAL_INVESTIGATOR)
Corewell HealthGrand RapidsMichigan49503-
Henry Ford Providence Southfield HospitalSouthfieldMichigan48075
Candice Edillo
[email protected]
Dipak Shah, MD (PRINCIPAL_INVESTIGATOR)
M Health Fairview St. John's HospitalMaplewoodMinnesota55109
Beth Jorgenson
[email protected]
Marat Yanavitski, MD (PRINCIPAL_INVESTIGATOR)
CentraCare Heart and Vascular CenterSaint CloudMinnesota56303
Audrey Hillebrand-Raap
[email protected]
Jacob Dutcher, MD (PRINCIPAL_INVESTIGATOR)
North Mississippi Medical CenterTupeloMississippi38801
Kristin Eads
[email protected]
James Stone, MD (PRINCIPAL_INVESTIGATOR)
Saint Luke's Hospital of Kansas CityKansas CityMissouri64111
Cheryl Rutherford
[email protected]
Chetan Huded, MD (PRINCIPAL_INVESTIGATOR)
Kansas City Cardiac Arrhythmia Research, LLCOverlandMissouri66211
Rachael Koeppe
[email protected]
Dhanunjaya Lakkireddy, MD (PRINCIPAL_INVESTIGATOR)
CHI Health / CommonSpirit Research InstituteOmahaNebraska68124
Himanshu Agarwal, MD (PRINCIPAL_INVESTIGATOR)
University of Nebraska Medical CenterOmahaNebraska68198
Melissa Howard
[email protected]
Jason Payne, MD (PRINCIPAL_INVESTIGATOR)
Catholic Medical CenterManchesterNew Hampshire03102-
Hackensack University Medical CenterHackensackNew Jersey07601-
Cooper University - Heart HouseHaddon HeightsNew Jersey08104
Kaitlyn Downey
[email protected]
John Costello, MD (PRINCIPAL_INVESTIGATOR)
New Mexico Heart InstituteAlbuquerqueNew Mexico87102
LaTasha Johnson
[email protected]
Sean Mazer, MD (PRINCIPAL_INVESTIGATOR)
Albany Medical Center / Capital Cardiology AssociatesAlbanyNew York12208
Chris Chapman
[email protected]
Augustin DeLago, MD (PRINCIPAL_INVESTIGATOR)
University of Buffalo / Kaleida HealthBuffaloNew York14203
Lindsay Moshides
[email protected]
Vijay Iyer, MD (PRINCIPAL_INVESTIGATOR)
Mount Sinai HospitalNew YorkNew York10029
Vivek Reddy, MD (PRINCIPAL_INVESTIGATOR)
Mission HospitalAshevilleNorth Carolina28801
Christina Riggsbee
[email protected]
Joshua Leitner, MD (PRINCIPAL_INVESTIGATOR)
TriHealthCincinnatiOhio45242
Marta McClellan
[email protected]
Hemal Shah, MD (PRINCIPAL_INVESTIGATOR)
Ohio Health Research InstituteColumbusOhio43214-
ProMedica Toledo HospitalToledoOhio43606
Sonya Inderrieden
[email protected]
Kasi Ramanathan, MD (PRINCIPAL_INVESTIGATOR)
UPMC HarrisburgMechanicsburgPennsylvania17050
Matthew Rutt
[email protected]
Hemal Gada, MD (PRINCIPAL_INVESTIGATOR)
Lankenau Heart InstituteWynnewoodPennsylvania19096
Ali Keramati, M.D. (PRINCIPAL_INVESTIGATOR)
Lifespan Health SystemProvidenceRhode Island02903-
Prisma HealthColumbiaSouth Carolina29203
Michael Cryer, MD (PRINCIPAL_INVESTIGATOR)
HCA Grand StrandMyrtle BeachSouth Carolina29572
Carley Brandli
[email protected]
John Sturdivant, MD (PRINCIPAL_INVESTIGATOR)
Trident Medical CenterNorth CharlestonSouth Carolina29406
Danielle Pagan
[email protected]
Frank Cuoco, MD (PRINCIPAL_INVESTIGATOR)
Erlanger Health SystemChattanoogaTennessee37403-
Tennova Healthcare - Turkey Creek Medical CenterKnoxvilleTennessee37934
Juliana Bailey
[email protected]
Malcolm Foster, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
Amanda Caroll
[email protected]
Christopher Ellis, MD (PRINCIPAL_INVESTIGATOR)
Houston MethodistHoustonTexas77030
Chinwe Ngumezi
[email protected]
Miguel Valderrabano, MD (PRINCIPAL_INVESTIGATOR)
Memorial Hermann Memorial City Medical CenterHoustonTexas77094
Amir Kashani, MD (PRINCIPAL_INVESTIGATOR)
Baylor Scott & White Research InstitutePlanoTexas75093
Emmitt Lavergne
[email protected]
Sibi Thomas, MD (PRINCIPAL_INVESTIGATOR)
CHRISTUS HealthTylerTexas75701
Jamie-Crystal Wylie
[email protected]
Stanislav Weiner, MD (PRINCIPAL_INVESTIGATOR)
Sentara NorfolkNorfolkVirginia23507-
Chippenham HospitalRichmondVirginia23225
Ariana Dickens
[email protected]
Charles Joyner, MD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth UniversityRichmondVirginia23219
Esoterica Berry
[email protected]
Jayanthi Koneru, MD (PRINCIPAL_INVESTIGATOR)
Carilion ClinicRoanokeVirginia24014
Jason Foerst, MD (PRINCIPAL_INVESTIGATOR)
Virginia Mason Medical CenterSeattleWashington98101
Ming Zhang, MD (PRINCIPAL_INVESTIGATOR)
West Virginia UniversityMorgantownWest Virginia26506
Danielle Walden
[email protected]
Ramesh Daggubati, MD (PRINCIPAL_INVESTIGATOR)
Bellin HealthGreen BayWisconsin54301
Katherine Guilliams
[email protected]
Rudolph Evonich, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Atrial fibrillationStroke
By specialty
CardiologyHeart diseaseNeurologyBrain disorders
By research site
Grandview Medical Center· Birmingham, ALAbrazo Arizona Heart Hospital· Phoenix, AZArizona Heart Arrhythmia Associates· Phoenix, AZBanner University Medical Center Phoenix· Phoenix, AZHonorHealth· Scottsdale, AZPima Heart & Vascular· Tucson, AZ

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